Improvements In Patient-reported Outcomes Research Articles

Margin convergence vs. superior capsular reconstruction for massive irreparable rotator cuff tears: outcomes are equivalent unless there is preoperative pseudoparesis

Margin convergence (MC) and superior capsular reconstruction (SCR) are common treatment options for irreparable rotator cuff tears in younger patients, although they differ in associated costs and operative times. The purpose of this study was to compare range of motion, patient-reported outcomes (PROs), and reoperation rates following MC and SCR. We hypothesized superior outcomes after SCR relative to MC regarding functional outcomes, subjective measures, and reoperation rates. This was a multicenter retrospective review of 59 patients from 3 surgeons treating irreparable rotator cuff tears with either MC (n=28) or SCR (n=31) and minimum 1-year follow-up from 2014-2019. Visual analog scale (VAS) for pain, Subjective Shoulder Value (SSV), active forward flexion (FF), external rotation (ER), retear rate, and conversion rate to reverse shoulder arthroplasty were evaluated. t tests and χ2 tests were used for continuous and categorical variables, respectively (P<.05). Baseline demographics, range of motion, and magnetic resonance imaging findings were similar between groups. Average follow-up was 31.5 months and 17.8 months for the MC and SCR groups, respectively (P<.001). The MC and SCR groups had similar postoperative FF (151°±26° vs. 142°±38°; P=.325) and ER (48°±12° vs. 46°±11°; P=.284), with both groups not improving significantly from their preoperative baselines. However, both cohorts demonstrated significant improvements in VAS score (MC: 7.3 to 2.5; SCR: 6.4 to 1.0) and SSV (MC: 54% to 82%; SCR: 38% to 87%). There were no significant differences in postoperative VAS scores, SSV, and rates of retear or rates of conversion to arthroplasty between the MC and SCR groups. In patients with preoperative pseudoparesis (FF<90°), SCR (n=9) resulted in greater postoperative FF than MC (n=5) (141°±38° vs. 67°±24°; P=.002). Both MC and SCR demonstrated excellent postoperative outcomes in the setting of massive irreparable rotator cuff tear, with significant improvements in PROs and no significant differences in range of motion. Specifically for patients with preoperative pseudoparesis, SCR was more effective in restoring forward elevation. Further long-term studies are needed to compare outcomes and establish appropriate indications.

Etanercept in Axial Spondyloarthritis, Psoriatic Arthritis, and Plaque Psoriasis: Real-World Outcome Data from German Non-interventional Study ADEQUATE.

For chronic diseases such as axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and plaque psoriasis (PsO), treatment goals include remission or at least low disease activity (LDA) by 12weeks. Improvements in symptoms such as pain and fatigue should also be treatment goals. ADEQUATE was a German, prospective, non-interventional study to evaluate the proportion of patients with rheumatoid arthritis, PsA, axSpA, or PsO who, in routine clinical practice, benefit from the continuation of treatment with etanercept (ETN) beyond 12weeks, even when their treatment goals have not yet been reached. Patient-reported outcomes (PROs) and changes in concomitant glucocorticoid use were also recorded. This article focuses on results for patients with axSpA and PsA; data for patients with PsO are described briefly. In total, 305, 254, and 70 patients with axSpA, PsA, and PsO, respectively, were included. Rates of remission at week12 and week24, respectively, were 19% and 18% for axSpA, 38% and 51% for PsA, and 7% and 19% for PsO. Rates of LDA at week12 and week24, respectively, were 39% and 45% for axSpA, 50% and 60% for PsA, and 34% and 51% for PsO. Extending treatment up to 52weeks was associated with stable rates of or further increases in remission and LDA rates. Improvements in pain, fatigue, and depression (axSpA, PsA, and PsO) and reductions in concomitant glucocorticoid use (axSpA and PsA) were observed. No new safety signals were detected. These findings confirm the effectiveness and safety of ETN in routine clinical practice for several indications and highlight potential benefits of continuing ETN treatment in patients who have not reached their treatment goals after 12weeks. Additional benefits included improvements in PROs and reduction of concomitant glucocorticoids. ClinicalTrials.gov NCT02486302.

Hip Arthroscopy in Recreational Athletes: Risk Factors For Failure to Return to Sport and Factors That Influence Psychological Readiness to Return to Sport

Objective: High level athletes achieve high rates of return to play and improved patient reported outcomes (PROMs) after hip arthroscopy for femoroacetabular impingement (FAI). However, few studies have evaluated return to sport rates in recreational athletes, risk factors for failure to return to sport, and the effect of psychological readiness to return to sport (RTS) within this population. We hypothesize that recreational athletes undergoing hip arthroscopy for FAI achieve high PROMs and rates of RTS and that psychological readiness is a risk factor for failure to RTS. Additionally, we hypothesize that male athletes and younger age are positively associated with psychological readiness to RTS. Methods: Retrospective review of prospectively collected data in our institution's Center for Hip Pain and Preservation Outcomes Registry identified recreational athletes with a minimum of 12 months follow-up, who underwent hip arthroscopy for FAI between 2008-2018. The primary outcome was RTS. The secondary outcomes were ---Hip-RSI (SF) score, modified Harris Hip Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), Hip Outcome Score Sport (HOS-Sport), and International Hip Outcome Tool (iHOT33). Results: 84.8% of recreational athletes returned to sport with 70.52% returning to the same level of play. Athletes who failed to RTS were younger (p-value=0.0427), last participated 9-12 months prior to surgery (32.26%) or had stopped participating in sports altogether (70.97%) (p-value=0.0002 and p-value=0.0013). Hip-RSI Score was a statistically significant predictor of failure to RTS at one and two years respectively (OR 0.915 (95%CI 0.87, 0.962) and OR 0.904 (95%CI 0.818, 0.999)). Increasing age had a positive effect on psychological readiness to RTS (0.5004-point increase in RSI score (p-value=0.0002)) while sex, BMI, additional ipsilateral surgery, and last participation in sport were not predictive of psychological readiness (p-values&gt;0.05). Conclusions: Recreational athletes undergoing hip arthroscopy achieve high rates of RTS, return to the same level of play, and demonstrate significant improvements in PROMs. The Hip-RSI-score was a statistically significant predictor of failure to RTS at 1 and 2 years post operatively. Lastly, higher psychological readiness for return to sport was seen in older recreational athletes undergoing hip arthroscopy for FAI.

Severe Preoperative Disability Is Associated With Greater Mental Health Improvements Following Surgery for Degenerative Spondylolisthesis: A Cohort Matched Analysis.

To evaluate preoperative disability's influence on patient-reported outcomes (PROs) following surgery for degenerative spondylolisthesis (DS). DS patients who underwent surgical intervention were retrospectively identified from a single-surgeon spine registry. Cohorts based on Oswestry Disability Index (ODI) < 41 (milder disability) and ≥ 41 (severe disability) were created. Demographic differences were accounted for with 1:1 propensity score matching. For the matched sample, perioperative and PRO data were additionally collected. PROs assessed included mental health, physical function, pain, and disability. Pre- and up to 2-year postoperative PROs were utilized. Average time to final follow-up was 15.7 ± 8.8 months. Improvements in PROs and minimal clinically important difference (MCID) rates were calculated. Continuous variables were compared through Student t-test and categorical variables were compared through chi-square tests. Altogether, 214 patients were included with 77 in the milder disability group. The severe disability group had worse postoperative day (POD) 1 pain scores and longer hospital stays (p ≤ 0.038, both). The severe disability group reported worse outcomes pre- and postoperatively (p < 0.011, all), but had greater average improvement in 12-item Short Form health survey mental composite score (SF-12 MCS), 9-Item Patient Health Questionnaire (PHQ-9), visual analogue scale (VAS)-back, and ODI by 6 weeks (p ≤ 0.037, all) and PHQ-9, VAS-back and ODI by final follow-up (p ≤ 0.015, all). The severe disability cohort was more likely to achieve MCID for SF-12 MCS, PHQ-9, and ODI (p ≤ 0.003, all). Patients with greater baseline disability report higher POD 1 pain and discharge later than patients with milder disability. While these patients report inferior physical/mental health before and after surgery, they report greater improvements in mental health and disability postoperatively.

Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials.

We examined the relationships of work productivity and activity impairment with key patient-reported outcomes (PROs) assessing pain, disease activity, and health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS). This post hoc analysis pooled available data from baseline to end of the double-blind phase of phase 2 and 3 placebo-controlled tofacitinib trials in patients with active AS. A repeated-measures longitudinal model assessed the relationships (linear or nonlinear) between Work Productivity and Activity Impairment questionnaire in Spondyloarthritis (WPAI:SpA) domains (absenteeism, activity impairment, presenteeism, and productivity loss) as outcomes and key PROs (total back pain, nocturnal spinal pain, Patient Global Assessment of Disease Activity, AS Quality of Life, EuroQol 5-Dimension 3-Level [EQ-5D-3L], and EQ-5D Visual Analog Scale [EQ-5D-VAS]) as predictors. Data from 330 to 475 patients were available, depending on the analysis. Relationships between WPAI:SpA domains and PROs were approximately linear. The worst PRO scores were associated with a decline in patients' work capacity (measured by activity impairment, presenteeism, and productivity loss [>65%]); the best scores were associated with improvements in WPAI:SpA domains (8%-23%). Incremental PRO improvements were associated with improvement of activity impairment, presenteeism, and productivity loss. Relationships between absenteeism and PROs were the weakest, owing to absenteeism being low in the study population. Evidence of linear relationships between work productivity and activity impairment with patient-reported pain, disease activity, and HRQoL was observed. Interventions to control pain and disease activity and improve HRQoL are therefore likely to improve work productivity and reduce activity impairment in patients with AS.

Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that causes pain and fatigue, reduces physical function, and negatively impacts health-related quality of life (HRQoL). In the phase III BE OPTIMAL and BE COMPLETE studies, bimekizumab demonstrated clinical efficacy and meaningful improvements in patient-reported outcome (PRO) measures in biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients, and those who had prior inadequate response/intolerance to tumor necrosis factor inhibitors (TNFi-IR). To examine the association between achieving increasingly stringent clinical disease control criteria and improvements in PRO measures in patients with active PsA receiving bimekizumab. Post hoc analysis of two phase III studies. BE OPTIMAL and BE COMPLETE assessed subcutaneous bimekizumab 160 mg every 4 weeks in bDMARD-naïve and TNFi-IR patients with active PsA. Disease control was assessed using American College of Rheumatology (ACR) response criteria, Minimal Disease Activity, Disease Activity Index for Psoriatic Arthritis, and the composite outcome of ACR50 and 100% improvement in Psoriasis Area and Severity Index. Associations between clinical disease control criteria and PRO measures of pain, fatigue, physical function, and HRQoL were assessed at week 16 and week 52/40 (BE OPTIMAL/BE COMPLETE). Achievement of increasingly stringent clinical disease control criteria was generally associated with sequentially greater improvements in all PRO measures, including pain. At week 52/40, 94.7% of bDMARD-naïve and 97.6% of TNFi-IR patients achieving ACR70 reported ⩾50% improvements in pain from baseline, and the greatest numerical improvements (-48.5 bDMARD-naïve; -54.7 TNFi-IR). This pattern was evident as early as week 16 and sustained when assessed at week 52/40 across the majority of clinical disease control criteria and PRO measures reported. The achievement of increasingly stringent thresholds of disease control was associated with corresponding greater improvements in PROs, for patients receiving bimekizumab treatment, irrespective of prior TNFi use. NCT03895203, NCT03896581, and NCT04009499.

Risankizumab Induction Therapy Achieves Early Symptom Improvements That Are Associated With Future Clinical and Endoscopic Outcomes in Crohn's Disease: Post Hoc Analysis of the ADVANCE, MOTIVATE, and FORTIFY Phase 3 Studies.

Crohn's disease [CD] symptoms are a main driver for impaired quality of life, and fast relief is important for patient care. Stool frequency [SF] and abdominal pain score [APS] are patient-reported outcomes [PROs] measuring symptom severity, which are supported as treatment targets by the STRIDE-II consensus. This post hoc analysis examined the efficacy of risankizumab [RZB], a humanised monoclonal antibody with high specificity for interleukin-23 p19, for providing early symptom relief, along with the prognostic value of early symptom relief for achieving future clinical and endoscopic endpoints. Individual and combined measures of SF and AP at Weeks 1, 2, and 3 were assessed in patients with moderate to severe CD who received 600 mg intravenous RZB or placebo [PBO] in the ADVANCE or MOTIVATE induction studies. Multivariate logistic regression was used to examine the predictiveness of early symptom improvement for clinical and endoscopic outcomes following RZB induction and maintenance. Higher rates of SF/APS clinical remission and enhanced clinical response were observed as early as Week 1 with RZB vs PBO. A larger proportion of patients achieved clinical endpoints with RZB vs PBO, irrespective of prior bio-failure status. Early PRO improvement was associated with a greater likelihood of achieving clinical and endoscopic improvement following 12-week induction and 52-week maintenance RZB dosing. After the first intravenous RZB induction dose, significantly greater rates of symptom improvement vs PBO were achieved. Improvements could be observed as early as Week 1 and were predictive of Weeks 12 and 52 clinical and endoscopic improvement.

Systematic Review of Clinical Outcomes After Proximal Tibia Anterior Closing-Wedge Osteotomy With ACL Reconstruction.

While increased posterior tibial slope (PTS) is an important risk factor for failure after anterior cruciate ligament (ACL) reconstruction, controversy exists regarding indications and outcomes of proximal tibia anterior closing-wedge osteotomy (ACWO) with concomitant ACL reconstruction in patients with ACL tears. To assess clinical outcomes after combined ACL reconstruction and proximal tibia ACWO. Systematic review; Level of evidence, 4. In accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, we performed a systematic review of the existing literature on ACWO and ACL reconstruction using PubMed (MEDLINE), Cochrane Library, Scopus, and Embase. The search phrases included "anterior closing wedge osteotomy,""anterior closing wedge tibial osteotomy,""anterior closing wedge proximal tibial osteotomy,""anterior cruciate ligament," and "revision anterior cruciate ligament." Non-English publications and single-patient case reports were excluded. Extracted data included study details, patient demographics, patient-reported outcomes (PROs), clinical outcomes, radiographic outcomes, complications, and return-to-sport (RTS) rates. A total of 6 studies with 110 patients (110 knees) were included. Two-stage ACWO and ACL reconstruction was reported in 2 studies of 78 patients (71%), while a single-stage technique was reported in 4 studies of 32 patients (29%). ACWO was performed in the setting of primary ACL tear in 23 patients (21%) and in recurrent ACL tear in 87 patients (79%). Patients demonstrated postoperative improvements in Lysholm, pivot-shift test, and side-to-side difference in anterior tibial translation. After ACWO, all studies reported mean postoperative PTS of <10° (range, 4.4°-9.2°). Of patients with available RTS data (n = 43), the same-level RTS rate ranged from 65% to 100%. A two-stage procedure reported in 1 study had a lower RTS rate (n = 13 of 20 [65%]) than that of 2 studies with single-stage procedure (n = 4 of 5 [80%] and n = 18 of 18 [100%]). The overall complication rate was 0.9% to 1.3%, and there were no reported ACL retears. The current evidence, which is constrained by the quantity and quality of studies, showed that ACWO with single- or two-stage ACL reconstruction in patients with ACL insufficiency and increased PTS was associated with significant improvements in PROs and high RTS rates.

Longitudinal Patient-Reported Outcomes and Clinical Outcomes By VES-13 and Comprehensive Geriatric Assessment in Older Adults with Aggressive Non-Hodgkin Lymphomas

Background: Older adults with aggressive non-Hodgkin lymphoma (NHL) can experience durable remissions with therapy but also substantial toxicities and healthcare utilization. The Vulnerable Elders Survey (VES-13) is a 13-item tool assessing age, self-rated health, and ability to perform physical and functional activities (score of 3+ indicates vulnerability). The Fondazione Italiana Linfomi comprehensive geriatric assessment (CGA) assesses age, comorbidities, and ability to perform physical and functional activities and classifies patients as fit, unfit, or frail. Both the VES-13 and CGA hold promise to risk stratify older adults for poor outcomes. Few data are available comparing these tools in assessing risk for poor survival and healthcare utilization, and prior studies have not examined the impact of therapy on longitudinal patient-reported outcomes (PROs). Methods: We conducted a longitudinal prospective study of 105 older adults with aggressive NHL at Massachusetts General Hospital or the Dana-Farber Cancer Institute between 9/2020 and 1/2023. Eligible patients were age &amp;gt;= 65 years at time of treatment initiation receiving combination chemoimmunotherapy. Patients could enroll up until cycle 1 day 8 of therapy. Patients completed questionnaires at baseline and 6 weeks, 12 weeks, 18 weeks, and 6 months post therapy initiation assessing demographics, quality of life (QOL-Functional Assessment of Cancer Therapy-Lymphoma [FACT-Lym]), depression and anxiety (Hospital Depression and Anxiety Scale [HADS]), and physical symptoms (Edmonton Symptom Assessment Scale-revised [ESAS-r]). At baseline patients also completed the VES-13 and underwent CGA evaluated by an oncologist. We utilized linear mixed models to examine longitudinal QOL, depression, anxiety, and physical symptoms. We assessed univariate factors associated with longitudinal QOL. Using Cox regression models controlling for gender, age-adjusted International Prognostic Index (IPI), hypoalbuminemia, Charlson comorbidity index (CCI), and lymphoma subtype, we assessed the relationship of VES-13 and CGA in separate models with overall survival (OS). We also examined factors associated with unplanned hospitalization within 6 months of therapy start using logistic regression. Results: We enrolled 106/163 (65.0%) patients. 1 patient was excluded due to treatment with an ineligible therapy. Patients had a median age of 73 years (range: 65-99, 38.1% &amp;gt;75, 21.9% &amp;gt;=80); most were male gender (64.8%), White race (96.2%), and married/with a life partner (72.4%). The most common lymphoma subtypes were DLBCL (73.0%), DLBCL/high grade B-cell lymphoma with MYC and BCL2 translocations (12.4%), and mantle cell lymphoma (10.5%). The majority (56/104, 53.8%) had an age-adjusted IPI of 2 or 3, over a third (34.3%) had a CCI score of 2+, and 82.9% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. 45.7% (48/105) had a VES-13 score of 3+. 40.0%, 9.5%, and 50.5% were fit, unfit, and frail, respectively, on CGA. QOL, depression, anxiety, and physical symptoms all improved over time (Figure 1). QOL improved regardless of age group, VES-13 category (&amp;lt;3 vs 3+), or CGA result (Figure 1). Compared to other patients, those 80+ years with either VES-13 score 3+ (β= -2.90, p=0.045) or frail on CGA (β= -3.68, p=0.007) had a worse QOL trajectory. Income &amp;gt; $50,000 annually (β=2.41; p=0.041) was associated with better QOL trajectory. VES-13 score of 3+ (HR=6.08; p=0.014) and frail on CGA (HR=5.20; p=0.028) were both associated with worse survival. Of those with follow up (N=66), 8 died within 1 year (1-year OS=87.9%), all of whom were both frail on CGA and had VES-13 score 3+. 25.8% (8/31) of the CGA frail patients and 28.6% (8/28) of those with VES-13 3+ died within 1 year. VES-13 score (OR=1.16, p=0.028) was associated with greater likelihood of unplanned hospitalization. Conclusion: Older adults with aggressive NHL often experience improvement in QOL and other PROs with treatment, even across age and frailty categories. VES-13 score and CGA identify patient groups at high risk for early death and poor QOL trajectory, for whom novel therapies and supportive care interventions are warranted. Higher VES-13 score is also associated with higher risk of unplanned hospitalization. Routine assessment of VES-13 and CGA has high potential for early identification of high risk patients and implementation of appropriate interventions.

Anatomic vs. reverse total shoulder arthroplasty with glenoid retroversion of at least 15 degrees in rotator cuff intact patients: a comparison of short-term results

BackgroundSevere glenoid deformity has been associated with inferior outcomes and higher complication rates in shoulder arthroplasty. In patients with intact rotator cuffs, there is no clear consensus as to whether anatomic total shoulder arthroplasty (aTSA) or reverse (rTSA) shoulder arthroplasty is the optimal implant in patients with glenoid deformities. The purpose of this study was to compare outcomes of aTSA vs. rTSA in glenoid deformities with greater than 15° retroversion. MethodsA retrospective review of a large multicenter database was conducted. All patients who underwent either aTSA or rTSA with an intact rotator cuff and glenoid retroversion 15° or greater with minimum 2-year follow-up were included. Range of motion (ROM), revisions, and patient reported outcomes (PROs) including Constant score, Simple Shoulder test, American Shoulder and Elbow Surgeons score, University of California Los Angeles shoulder score, Shoulder Pain and Disability Index), Shoulder Arthroplasty Smart score were collected for all patients pre and postsurgery. ResultsOverall, 336 patients were included with 187 receiving an aTSA and 149 rTSA. Reverse patients overall had more comorbidities (75.0% vs. 65.1%; P = .05) and were older (70.9 ± 7.0 vs. 66.3 ± 7.7 years; P < .001). Average follow-up for the aTSA group was 62.0 ± 37.8 months vs. 40.6 ± 22.9 months for rTSA (P < .001). Preoperative retroversion in the anatomic group averaged 20.7 ± 5.5 degrees vs. 24.2 ± 7.7 in reverse patients (P < .001). Both groups demonstrated significant improvements in all PROs and ROM from pre to postsurgery. At latest follow-up aTSA patients had significantly better internal rotation scores (4.9 ± 1.6 vs. 4 ± 1.8; P < .001), external rotation (50 ± 19 vs. 38 ± 18; P < .001) and Shoulder Arthroplasty Smart scores (80.2 ± 13.5 vs. 76.6 ± 11.3; P = .017) but worse pain VAS (1.5 ± 2.3 vs. 0.9 ± 1.9; P = .016). There was no significant difference in abduction or forward elevation or PRO’s (Shoulder function, Simple Shoulder test, Constant, American Shoulder and Elbow Surgeons score, University of California Los Angeles shoulder score, or Shoulder Pain and Disability Index). Overall revision rate (7% vs. 1%; P = .002) was higher in aTSA. ConclusionATSA and rTSA results in significant improvements in patients with glenoid retroversion equal or greater than 15°. Anatomic TSA patients have better postoperative internal rotation score, external rotation, and SAS score but demonstrated no other significant improvement in ROM or PRO. However, there was significantly higher rate of complications and revisions with short-term follow-up following aTSA.

Arthroscopic Lysis of Adhesions for Stiffness After Surgical Management of Proximal Humerus Fractures Leads to Satisfactory Outcomes in Most Patients

To report patient-reported outcomes (PROs), range of motion (ROM), and satisfaction, in patients who underwent arthroscopic lysis of adhesions for stiffness after open reduction with internal fixation (ORIF) or reverse shoulder arthroplasty (RSA) for fracture. A retrospective review was performed to identify patients with stiffness who underwent arthroscopic lysis of adhesions following ORIF or RSA for proximal humerus fracture at a single institution between 2012 and 2021 with minimum 1-year follow-up. PROs including visual analog scale for pain (VAS), American Shoulder and Elbow Surgeons (ASES), and Subjective Shoulder Value (SSV), as well as active ROM including forward flexion (FF), external rotation (ER), internal rotation (IR), were collected pre- and postoperatively. Attempted nonoperative treatment before arthroscopic lysis of adhesions was documented. Complications and satisfaction were also recorded. A total of 21 patients met the study criteria (4 RSA, 17 ORIF), with an average age of 66.7 ± 8 years. The study sample comprised mostly of female patients (90%). The mean time from the index surgery to arthroscopy was 9 months, and mean follow-up post-lysis was 17 months. Patients with ORIF reported significant pain relief (VAS, Δ -3.2) and improvement in range of motion (FF, Δ 36°; ER, Δ 20°; IR Δ 3 spinal levels) and PROs (ASES, Δ 34.7; SSV Δ 44.8) (P < .01) after lysis. Patients with RSA had significant improvement in ASES (Δ 21.8; P= .04), SSV (Δ 8.8; P= .04), and FF (Δ38; P= .02) but did not have significant improvement in VAS (Δ -2; P= .2), ER (Δ 0°; P= 1.0), and IR (Δ 1 spinal level; P= .2). Satisfaction was 100% in the RSA cohort and 82% in the ORIF cohort. No complications were observed. Arthroscopic lysis of adhesions for stiffness after surgical management of proximal humerus fracture leads to satisfactory outcomes in most patients. Post-ORIF, patients may achieve improvement in PROs and global ROM, whereas post-RSA, patients may achieve improvement in PROs and FF but do not necessarily improve in rotational ROM. Level IV, therapeutic case series.

Arthroscopic Repair of Retracted Large and Massive Rotator Cuff Tears With and Without Augmentation With a Bio-Inductive Collagen Implant Reveals Substantial and Comparable Clinical Improvement

PurposeThe study objective was to compare clinical and imaging results following repair of retracted large and massive full thickness rotator cuff tears, including revision repairs, with and without augmentation with a bio-inductive collagen implant. MethodsThe study group comprised 24 patients (17 males) with retracted 2-3 tendon rotator cuff tears undergoing arthroscopic repair followed by on-lay augmentation with a bio-inductive collagen implant. The control group comprised 24 patients (19 males) matched by tear size undergoing repair without augmentation. Mean patient age at repair in both groups was 61 years. Active range of motion (ROM) and patient-reported outcomes (PROs) were recorded pre- and post-operatively. Non-contrast high-field MRI was obtained in 20/24 collagen implant patients and 17/24 control patients at minimum 6 months follow-up to assess tendon healing. ResultsASES scores and SST improved from 35 to 86 and 3.6 to 9.3, respectively, in the collagen implant group and from 39 to 87 and 3.9 to 9.7 in the control group. VAS-pain improved from 6.0 to 0.9 and from 5.9 to 0.9 in the collagen implant and control groups, respectively (p<0.001 for all). Overall improvements in ROM and PROs were similar in both groups. MRI revealed intact repairs in 11/20 (55%) patients in the patch group and 9/17 (53%) in the control group. Two patients in each group were revised to reverse shoulder arthroplasty. ConclusionsArthroscopic repair of retracted large and massive rotator cuff tears, including revision repairs, with and without augmentation using a bio-inductive collagen implant results in substantial and comparable early clinical improvement, although predictable healing remains elusive. Further work is needed to optimize patient selection for massive rotator cuff repair and define more precisely the indications for augmentation of these repairs using the collagen implant.

Effects of Idecabtagene Vicleucel (Ide-Cel) Versus Standard Regimens on Health-Related Quality of Life (HRQoL) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Who Had Received 2-4 Prior Regimens: Updated Results from the Phase 3 KarMMa-3 Trial

Background: An interim analysis (data cutoff date April 18, 2022) of the international, open-label, phase 3 KarMMa-3 trial (NCT03651128) showed the chimeric antigen receptor T cell therapy idecabtagene vicleucel (ide-cel) significantly improved progression-free survival and treatment response rates, as well as HRQoL, as compared with standard regimens, in patients with triple-class exposed (TCE) RRMM who had received 2-4 prior regimens (Rodriguez-Otero P, et al. N Engl J Med 2023;388:1002-1014; Delforge M, et al., HemaSphere, 2023;7(S3):P905). The aim of the present study was to analyze the effect of ide-cel versus standard regimens (daratumumab [DARA], pomalidomide, and dexamethasone [DEX]; DARA, bortezomib, and DEX; ixazomib, lenalidomide, and DEX; carfilzomib and DEX; or elotuzumab, pomalidomide, and DEX) on HRQoL in KarMMa-3 trial participants with an extended follow-up of patient-reported outcomes (PRO) data collection (data cutoff date April 28, 2023). Methods: In KarMMa-3, HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20), and EQ-5D-5L. HRQoL assessments were completed at screening (baseline); the day of ide-cel infusion or the first dose of standard treatment; and monthly from 2 to 28 months; and every 3 months thereafter. The prespecified primary outcomes of interest were EORTC QLQ-C30 global health status/QoL, physical functioning, cognitive functioning, fatigue, and pain; EORTC QLQ-MY20 disease symptoms and side effects of treatment; and the EQ-5D visual analog scale (EQ-VAS). Least squares (LS) mean changes from baseline through month 25 for ide-cel and standard regimens were compared by constrained longitudinal data analysis (cLDA). Effect sizes were estimated by Hedges' g. The effect of ide-cel versus standard regimens on time to confirmed improvement and deterioration in HRQoL (defined by prespecified change thresholds and sustained duration) were compared by stratified Cox proportional hazards regression. There was no adjustment for multiple testing, and all P values reported are nominal. Results: Overall, 254 patients were randomized to the ide-cel arm and 132 to the standard regimens arm. Baseline characteristics were well balanced across treatment arms; both arms had a median age of 63 years, a median of 3 prior anti-myeloma regimens, and median time from MM diagnosis to screening was 4 years. The baseline HRQoL scores were generally comparable between treatment arms. Overall LS mean changes from baseline to month 25 showed significant differences (nominal P value &amp;lt; 0.05) in favor of ide-cel for 18 out of 21 HRQoL domains, with effect sizes (Hedges' g) of 0.27 to 0.82 (Table). For 13 of these domains (including 6 primary domains of interest), the difference in overall LS mean change from baseline exceeded the prespecified minimum important difference (MID) threshold. Time to confirmed improvement was significantly shorter in the ide-cel arm than the standard regimens arm for 19 domains, including all primary domains of interest (Table). Time to confirmed deterioration showed trends of being longer in the ide-cel arm than the standard regimens arm for most domains and was significantly longer for emotional functioning, cognitive functioning, social functioning, dyspnea, and constipation as measured by the EORTC QLQ-C30. The time to confirmed deterioration in side effects of treatment (based on the EORTC QLQ-MY20) was significantly longer for patients in the ide-cel arm and time to confirmed improvement was significantly faster, as compared with the standard regimens arm (Table). Conclusions: In the KarMMa-3 trial, patients with TCE RRMM who had received 2-4 prior regimens, ide-cel significantly and meaningfully improved MM-relevant symptoms, functioning, and overall health status/HRQoL compared with standard regimens. Confirmed HRQoL improvements in the ide-cel arm occurred sooner than standard regimens. PRO improvements were sustained over more than 2 years, which is notable after a single infusion treatment with ide-cel. These patient-reported findings further support the benefit of ide-cel in this patient population.

Patient-Reported Outcomes (PROs) 3 and 6 Months After Pulmonary Rehabilitation Following COVID-19

If COVID-19 disease sequelae also (co-)affect the respiratory organs, national and international guidelines recommend pulmonary rehabilitation (PR). So far, however, no studies are available from Germany on the course after PR, nor on possible course differences between the two Long COVID subgroups "Ongoing symptomatic COVID-19" and "Post-COVID-19 syndrome" (PCS). In a prospective observational study, patient-reported outcomes (PROs) regarding exertional dyspnea, quality of life, pain, fatigue, depression, and anxiety were assessed at the beginning of PR (T1), end of PR (T2), and after 3 (T3) and 6 months (T4). Statistical analyses were performed using latent difference models. There were 224 rehabilitation patients (MAge=54.4; SDAge=10.4; 42.0% female) included in the study. During PR, all PROs improved significantly. After PR, improvements either persisted with large pre-post effect sizes (exertional dyspnea, quality of life), decreased slightly to small pre-post effect sizes (depression, fatigue), or decreased to baseline levels (anxiety, pain). PCS patients had greater burdens in depression, fatigue, and pain at baseline, but did not differ in trajectories. Indicators of the severity of the preceding acute phase (oxygen therapy, ICU treatment, ventilation) were associated with higher burdens at T0 in depression, fatigue, and pain, but not with the courses during and after PR. In contrast, female patients showed higher burdens in both depression and fatigue at T1 and higher pre-post effects than male patients. The fact that improvements in PROs occurred in both subgroups only during PR, but not during the follow-up period suggests that the changes are not due to the natural healing process but at least partly due to PR. Moreover, the results suggest that both patient groups may benefit from PR. Persisting improvements in exertional dyspnea and quality of life and, to a reduced extent, in depression and fatigue until 6 months after PR, but not in pain and anxiety warrant study of additional multimodal interventions that may be needed to maintain these effects.

Impact of American Society of Anesthesiologists' Classification on Postoperative Satisfaction and Clinical Outcomes Following Lumbar Decompression: Cohort-Matched Analysis.

Retrospective cohort. The aim was to compare patient-reported outcomes (PROMs), minimum clinically important difference (MCID) achievement, and postoperative satisfaction following minimally invasive lumbar decompression in patients stratified by American Society of Anesthesiologists (ASA) classification. Some guidelines recommend against performing elective procedures for patients with an ASA score of 3 or greater; however, long-term postoperative outcomes are not well described. Primary, single-level, minimally invasive lumbar decompression procedures were identified. PROMs were administered at preoperative, 6-week, 12-week, 6-month, 1-year, 2-year timepoints and included Patient-Reported Outcomes Measurement Information System-Physical Function, visual analog scale (VAS) back/leg, Oswestry disability index (ODI), and 12-item short form physical component score. Satisfaction scores were collected postoperatively for VAS back/leg, ODI, and individual ODI subcategories. Patients were grouped (ASA<3, ASA≥3), and propensity scores were matched to control for significant differences. Demographic and perioperative characteristics were compared using χ 2 and the Student's t test. Mean PROMs and postoperative satisfaction were compared at each time point by a 2-sample t test. Postoperative PROM improvement from the preoperative baseline within each cohort was calculated with a paired t test. MCID achievement was determined by comparing ΔPROMs to established thresholds and comparing between groups using simple logistic regression. One hundred and twenty-nine propensity-matched patients were included: 99 ASA<3 and 30 ASA≥3. No significant demographic differences were observed between groups. ASA≥3 patients experienced significantly increased length of stay and postoperative narcotic consumption on surgery day ( P <0.048, all). Mean PROMs and MCID achievement did not differ. The ASA<3 cohort significantly improved from the preoperative baseline for all PROMs at all postoperative time points. ASA<3 patients demonstrated higher levels of postoperative satisfaction at 6 weeks for VAS leg, VAS back, ODI, sleeping, lifting, walking, standing, sex, travel, and at 6 months for VAS back ( P <0.045, all). ASA≥3 patients may achieve similar long-term clinical outcomes to ASA<3 patients, though they may show poorer short-term satisfaction for disability, leg pain, and back pain, which could be related to differing preoperative expectations.

Revision Total Ankle Arthroplasty Outcomes in a Large Single-Center Series: Evaluation of Coronal Plane Deformity Correction and Patient Reported Measures

Category: Ankle Arthritis Introduction/Purpose: As total ankle arthroplasty (TAA) rises in popularity nationwide, the incidence of major complications and need for revision TAA will continue to increase. A better understanding of the ability to durably correct deformity and improve patient reported outcomes (PROs) in the TAA revision setting is paramount for surgeons facing the impending wave of failed TAA. Thus, the purpose of this study was to present the largest single-center case series of revision TAA to date and to evaluate improvement in PROs and maintenance of correction of coronal plane deformity in patients undergoing this procedure. Methods: This was a single-center, retrospective review of 87 revision TAAs performed between 2007 and 2022. Reoperations for cyst formations only or without metallic component exchange were excluded. The two most common implants used for revision TAA were Inbone II (n=65) and Inbone I (n=14). Mean follow-up was 2.8 ± 2.9 years. Data on patient preoperative characteristics, concurrent procedures, and postoperative complications were collected. The primary outcome measures were time to major complication, reoperation, and infection. Secondary outcomes included PROs and correction of coronal plane deformity measured from both the tibial plafond and talar articulating surface from pre- to post-operatively. Cox regression analyses were performed to compute survivorship. Results: The most common concurrent procedures performed concomitantly with revision TAA were gastrocnemius recession (n=31, 35.6%), subtalar arthrodesis (n=18, 20.7%), and talonavicular arthrodesis (n=5, 5.7%). Mean preoperative coronal plane deformity measured off both the tibial plafond and talar articular surface improved after revision TAA. 1- and 5-year survivorship from major complication, reoperation, and infection is shown in Table 2. Fourteen patients underwent subsequent revision, including TAA (n= 6, 6.9%), arthrodesis (n= 4, 4.6%), below-the-knee amputation (n= 2, 2.3%), or implantation of an antibiotic spacer (n= 2, 2.3%). At one-year postoperatively, mean VAS pain score, SF36, and AOFAS Hindfoot score was 18.2 ± 16.0, 73.0 ± 13.3, and 68.8 ±:9.3, respectively, representing an improvement in PROs after revision TAA. Conclusion: In the largest single-center series of patients undergoing single or double component exchange revision TAA, we demonstrate durable improvements in coronal plane deformity measured off both the tibial plafond and talar articular surface. We also noted 63.0% survivorship with regards to reoperation and improvements in average PROs across the cohort. Overall, revision TAA is a successful procedure, but is associated with higher failure rates at 5 years than primary TAA.

Long-Term Outcomes After Total Ankle Arthroplasty: A Systematic Review

Category: Ankle Arthritis; Ankle Introduction/Purpose: There is a paucity of aggregate literature reporting on long-term patient-reported outcomes (PROs) and implant failure after total ankle arthroplasty (TAA). The purpose of this study is to report an aggregate of literature on minimum 10-year patient-reported outcomes after total ankle arthroplasty. Methods: A systematic review on minimum 10-year PROs of TAA was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Pubmed, Scopus, and Cochrane Trials were queried on December 28th, 2022, with the following keywords: (ankle) AND (replacement or arthroplasty) AND (long-term or 10-year). Primary research articles were included if they reported minimum 10-year PROs for patients undergoing primary TAA and written in English. Forest plots with heterogeneity were created for PROs reported preoperatively and postoperatively in three or more studies. Long-term was defined as minimum 10-year follow-up. Survivorship was defined by implant failure which was determined uniquely by each study. Results: Six studies met the inclusion criteria with all 6 studies being level IV. A total of 277 ankles with average age range of 54-60.9 years were included in the study with follow up ranging from 10 to 24 years. The primary indication for total ankle replacement was osteoarthritis. Two of the six studies reported significant improvement in PROs following surgery. The remaining 4 studies also demonstrated improvement in PRO however no p values were reported. A forest plot was generated for the AOFAS score and I2 of 67% was calculated. Survivorship at a minimum of 10 year follow up ranged from 66-94.4%. Average time to implant failure ranged from 54.7-166 months. Conclusion: Patients undergoing primary TAA demonstrated improved outcomes at minimum 10-year follow-up. However, they demonstrated variable rates of survivorship ranging from 66-94.4% with average time to implant failure ranging from 54.7 – 166 months.

Obesity Significantly Impacts Patient Reported Outcomes after Total Ankle Arthroplasty: Results from 615 Controls and 478 Patients with Obesity

Category: Ankle Arthritis Introduction/Purpose: There is limited data evaluating the effect of obesity on outcomes following total ankle arthroplasty (TAA), especially in adequate sample sizes to detect impacts on patient reported outcomes (PROs). The purpose of this study was to assess the effect of obesity on complication rates and PROs. Methods: This was a single-institution, retrospective study of 1,093 primary TAA performed between 2001 and 2020. Minimum follow-up was 2 years. Patients were stratified by body mass index (BMI) into Control (BMI=18.5-29.9; n=615), Obesity Class I (BMI=30.0-34.9; n=285), and Obesity Class II (BMI&gt;35.0; n=193) groups. Patient information, intraoperative variables, postoperative complications, PRO measures were compared between groups using univariable statistics. Multivariable Cox regression was performed to assess risk for implant failure. Mean follow-up was 5.6 years (sd:3.1). Results: Compared to Control and Class I, Class II patients had the lowest mean age (p=0.001), highest mean ASA score (p &lt; 0.001), and greatest proportion of female sex (p &lt; 0.001) and Black/African American race (p=0.005). There were no statistically significant differences in postoperative complications (infection, implant failure, or impingement) across the BMI classes (p&gt;0.05). Preoperatively, Class II had lower (worse) mean scores for FAOS Pain and ADL subscales than Controls (posthoc pairwise p&lt; 0.001 for both). At final follow-up, both Class II and Class I had lower (worse) mean SMFA (posthoc pairwise p&lt; 0.001 and p=0.030, respectively) and SF36 scores (posthoc pairwise p&lt; 0.001 and p=0.005, respectively) than Controls. Conclusion: At midterm follow-up, obesity was not associated with increased rates of complications after TAA. Patients with obesity reported worse musculoskeletal function and overall quality of life after TAA but there was no differential improvement in PROs across BMI classes. To our knowledge, this is the largest single institution study to date examining the effect of obesity on outcomes after primary TAA.

Mid- to Long-Term Outcomes of the STAR Total Ankle Replacement

Category: Ankle Arthritis; Ankle Introduction/Purpose: The Scandinavian Total Ankle Replacement (STAR) is a widely used ankle prosthesis, but mid- to long-term follow up remains limited. In thirteen different studies involving 939 STAR total ankle prostheses, the average duration of follow- up for recipients was 3.9 years. Thus, we sought to evaluate the STAR at the mid- to long-term interval with regards to survivorship, complications, and patient reported outcomes (PROs) in one of the largest series with the longest-term follow up to date. Methods: All patients managed with a primary STAR prosthesis at our institution from March 2002 through January 2017 were included in the analysis. Demographic characteristics including gender, race, age, diabetes status, body mass index (BMI), smoking status, American Society of Anesthesiologist (ASA) score, and surgery time were summarized. The cumulative incidence of implant failure was at 5 years and the last recorded time to event (8 years) were reported with 95% confidence intervals (CI). Paired t- tests were used to compare pre-operative and 5 year post-operative (±1 year) for PROs including Visual Analog Scale (VAS), Short Musculoskeletal Function Assessment (SMFA), Short-form-36 (SF-36), and American Orthopaedic Foot &amp; Ankle Society (AOFAS) hindfoot subscales. Additionally, intra- and post-operative complications were recorded. All statistical analysis were conducted in SAS 9.4 (Cary, NC). Statistical significance was assessed at α = 0.05. Results: 247 patients with a unilateral STAR procedure were included in this analysis. Demographics are listed in Table 1. The average number of years of follow-up was 5.71 ± 4.07 years. The cumulative incidence of implant failure at 5 years was 7.7% (95% CI 4.3%-12.5%). The last failure event occurred at 8 years post-implant. The cumulative incidence of implant failure at 8 years was 11.1% (95% CI 6.3%-17.3%) (Table 2, Figure 1). The most common post-operative complications were impingement (N = 39, 15.8%), ankle pain (N = 22, 8.9%), and implant failure (N = 16, 6.5%) (Table 3). With regards to PROs, patients significantly improved between baseline and 5-year follow up in all measures (all p&lt; 0.001; Table 4). Conclusion: At mid- to long-term follow up, patients receiving the STAR prosthesis experienced a significant and durable improvement in PROs across multiple functional indices. Complication and failure rates were lower than those reported in previous series evaluating the STAR, with an observed survivorship of 88.9% at 8-year follow up.

Multiligament Ankle Instability Following Rotational Ankle Injuries: A Prospective Cohort Study

Category: Sports; Arthroscopy Introduction/Purpose: Rotational ankle injuries are frequent and mostly benign. However, chronic pain and residual instability following an index rotational trauma can happen. The diagnostic elucidation of the pain source is challenging, with ligamentous insufficiency, osteochondral injuries, and impingement/arthritis representing potential causes for symptoms. The prevalence and pattern of the residual isolated or combined ligamentous ankle instability following rotational injuries are not entirely elucidated in the literature. In this prospective cohort study, we aimed to assess the frequency of combined ligamentous instability (lateral, medial, and syndesmotic) in patients with chronic ankle pain (&gt;6 months) following rotational ankle injuries that failed conservative treatment and underwent surgical treatment. We also aimed to assess improvement in patient-reported outcomes (PROs) following treatment of the diagnosed conditions. Methods: IRB-approved prospective cohort study. We included patients with history of chronic pain (&gt;6 months) following a rotational ankle injury, with clinical signs of combined ligamentous instability of at least two ligamentous complexes (lateral, medial, and syndesmotic), and that failed conservative treatment (&gt;3 months). All patients underwent surgical treatment. Diagnostic arthroscopic assessment was performed. Syndesmotic instability was considered positive if a metallic sphere of 3mm could be inserted in the anterior syndesmotic space. Deep deltoid instability was confirmed with a “pass-through sign” when a 4.0mm shaver could be introduced in the medial gutter. Lateral ankle instability was confirmed with a positive rotatory drawer test under fluoroscopic assessment. Presence of isolated or combined ligamentous instability was noted and patients received appropriate open surgical treatment for the confirmed ligamentous insufficiencies. Presence of associated osteochondral injuries, peroneal pathology and anterior bony impingement was also recorded. PROs were collected pre-operatively and at most recent follow-up. Results: A total of 27 patients were included (9 males/18 females), mean age 35.9 years (range, 18-68) and average BMI 31.3kg/m2(CI, 28.1-34.5). Eighty-nine percent had ankle sprains, and 11% rotational ankle fractures treated conservatively. Intraoperative assessment demonstrated positive lateral, medial, and syndesmotic instability in respectively 96%, 81%, and 78% of the patients. Most common combined instabilities were: 59% multidirectional (all three complexes), 19% rotational (medial+lateral), 15% anterolateral (lateral+syndesmotic), and 4% anteromedial (medial+syndesmotic). Isolated lateral instability was present in only one patient (4%). Peroneal tendon pathology, osteochondral injuries and anterior bony impingement were found in respectively 67%, 19%, and 26% of the patients. The average postoperative follow-up was 22.2 months (3-39 months). Significant improvements in VAS (P=0.0024), PROMIS Pain Interference (p=0.024), and EFAS scores (p=0.022) were observed. Conclusion: In this prospective cohort study, combined multiligament instability was extremely frequent in patients with chronic pain following rotational ankle injuries. Ninety-six percent of patients had confirmed intraoperative instability of at least two of the three ankle ligamentous complexes. Multidirectional (lateral, medial, and syndesmotic) (49%), rotational (lateral and medial) (19%), and anterolateral (syndesmotic and lateral) (15%) instabilities were the most frequent injury patterns. Following ligamentous repair/reconstruction, significant improvements in PROs were observed at an average follow-up of 22-months. Our study highlights that the diagnosis of residual multiligament ankle instability should be considered in patients with chronic ankle pain following rotational injuries.