Significant Improvements In Patient-reported Outcomes Research Articles

Does exercise therapy improve patient-reported outcomes in rheumatoid arthritis? A systematic review and meta-analysis for the update of the 2020 JCR guidelines for the management of rheumatoid arthritis.

This study aimed to evaluate the impact of exercise therapy on patient-reported outcomes (PROs) in rheumatoid arthritis (RA) as part of the process of updating the 2020 Japanese guidelines for the management of RA according to the Grading of Recommendations, Assessment, Development, and Evaluation system. We searched PubMed, Japana Centra Revuo Medicina Web, and the Cochrane Library (from 2009 to 2018) to identify articles that evaluated PROs of exercise therapy and RA disease activity. A total of 662 articles were identified, including nine RCTs, and meta-analyses were performed on six RCTs on systemic exercise therapy and three RCTs on upper extremity exercise therapy. Analyzed exercise therapies were diverse, differing in target population, intervention method, and duration. Significant improvements were observed in the Health Assessment Questionnaire Disability Index (mean difference -0.35, 95% confidence interval (CI): -0.60 to -0.10), pain (standardized mean difference -2.04, 95% CI: -3.77 to -0.32), and SF-36. For upper extremity exercise therapy, significant improvements in PROs (Disabilities of the Arm, Shoulder, and Hand Questionnaire, Michigan Hand Outcome Questionnaire) were observed. Exercise therapy in RA treatment improves patient subjective assessment of pain, physical function, and quality of life.

Abstract PS9-21: Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program

Abstract Background: With breast cancer (BC) treatment primarily managed in the ambulatory setting opportunities exist to provide support services to individuals that enhance their ability to manage side effects of treatment and their overall health outcomes. The aim of this randomized control trial was to evaluate the effect of a digital health coaching program on patient reported outcomes (PROs) and experience of women with BC undergoing chemotherapy treatment in the ambulatory setting. Methods: Women newly diagnosed with BC were randomized to receive either a 3-month digital health coaching intervention or standard of care support services provided by the treating hospital. PROs were captured at baseline and monthly for 3 months. The primary objective compared Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale scores between arms at the 3-month assessment. Secondary objectives evaluated the PROMIS physical and mental subscales, and the MD Anderson Symptom Inventory (MDASI) for differences between arms and over time. Summary statistics were used to describe demographic and baseline clinical characteristics by arm. Linear mixed effects models were used to assess PROMIS and MDASI over time. Statistical analysis were performed using Stata/MP v15.0. Results: A total of 210 subjects were randomized to the control arm and 208 to the digital health coaching intervention. A significant time (Table 1) but not intervention effect was observed. The mean (SD) of the PROMIS physical health t-score for the control arm was 43.9 (4.7) and 44.1 (4.3) for the intervention arm (p = 0.699). The mean (SD) of the PROMIS mental health t-score for the control arm was 45.3 (5.4) and 45.1 (5.0) for the intervention arm (p = 0.742). The mean (SD) of MDASI severity score for the control arm was 2.4 (1.6) and was 2.5 (1.8) for the intervention arm (p = 0.715). The mean (SD) of the MDASI interference for the control arm was 2.6 (2.3) and was 2.8 (2.3) for the intervention arm (p = 0.633). Of 208 individuals randomized to the intervention, the majority (n=195; 94%) preferred engagement by phone, email and text. Participants averaged 9.17 calls with a mean duration of 13.04 minutes per call, 12.3 outbound texts to and 3.8 inbound texts from the participant, and a 47% email open rate over the course of 12-weeks. Conclusions: Study results suggest that while digital health coaching did not produce a statistically significant improvement in PRO over the course of the first 3 months of treatment, it did result in engagement that could be leveraged during and potentially beyond primary treatment for women with BC. PRO scores reflected minimal symptom burden and high global health at baseline before the start of treatment, which predictably declined over the course of treatment. Results informed the development of a currently enrolling expansion trial for individuals with diverse treatment types to evaluate which population receives the greatest benefit. Given the need for increasing engagement using telehealth solutions, the optimization of digital health coaching for individuals with BC is timely and increasingly relevant to promote optimal health self-efficacy and PROs. Table 1. Linear Mixed Models of PROMIS and MDASI Scores Over TimePROMISEffectBeta95% LB95% UBp-valuePhysicalTime<0.00130-0.88-1.50-0.260.00660-0.74-1.390.090.02690-1.88-2.53-1.22<0.001Intervention0.12-0.730.980.980MentalTime<0.00130-3.53-4.22-2.85<0.00160-3.94-4.66-3.22<0.00190-4.64-5.36-3.92<0.001Intervention-0.25-1.130.630.583MDASIEffectBeta95% LB95% UBp-valueSeverityTime<0.001301.170.991.35<0.001600.990.811.18<0.001901.261.061.45<0.001Intervention-0.08-0.330.160.499InterferenceTime<0.001301.321.081.58<0.001601.190.921.46<0.001901.561.291.83<0.001Intervention-0.09-0.420.240.587 Citation Format: Kelly J Brassil, Bryan Fellman, Brett Wisse, Diana Urbauer, Valerie Shelton, Carolyn Harty, Mazi Rasulnia. Patient reported outcomes of newly diagnosed women with breast cancer enrolled in a digital health coaching program [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-21.

Effect of Gender Differences on Patient-Reported Outcomes and Complications in Total Ankle Replacement.

The purpose of this study was to evaluate gender differences in patient outcomes and complications following total ankle replacement (TAR). Consecutive patients who underwent primary TAR from July 2007 through May 2016 were prospectively followed and retrospectively reviewed. Demographic, operative, patient-reported outcomes (PROs), and complication data were collected and analyzed. PROs included the visual analog scale (VAS), 36-Item Short-Form Health Survey (SF-36), American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot scale, and Short Musculoskeletal Function Assessment (SMFA). A total of 475 patients were evaluated, including 248 males (52.2%) and 227 females (47.8%) with an average of 56.8 months follow-up. Women were more likely to have inflammatory arthritis (13.7% vs 2.8%; P < .01) and significantly worse preoperative SF-36 total, SF-36 mental health component, AOFAS total, AOFAS pain, SMFA function, and SMFA bother scores (all P < .05). Both genders demonstrated significant improvement in PROs at 1, 2, and 5 years. The magnitude of improvement was similar between genders for all PROs (all P < .05) with the exception of SF-36 physical function, which was greater in men. Females underwent more nonrevision reoperations (32.2% vs 22.6%; P = .0191), but there was no significant difference in failure rates (male 7.3% vs female 3.5%; P = .07). The reoperation and failure rates at 2 years postoperation were 10.1% and 1.6% for men and 18.5% and 0.9% for women, respectively. Women undergoing TAR were more likely to have worse preoperative PROs and higher rates of nonrevision reoperations, which remains true when controlling for their increased incidence of inflammatory arthritis. However, women reported similar improvements in PROs and had similar prosthetic survival rates as men. Increased understanding of these disparities, combined with gender-based interventions, may further advance patient outcomes. Level III, therapeutic, retrospective comparative series.

Comparison of Superior Capsular Reconstruction and Partial Infraspinatus Repair: A Matched-Pair Analysis of Irreparable Rotator Cuff Tears.

Background:Superior capsular reconstruction (SCR) represents a new option for the treatment of irreparable rotator cuff tears.Purpose/Hypothesis:This study aimed to evaluate the clinical and radiologic outcomes of SCR and compare them with the outcomes of partial repair (PR) of the infraspinatus tendon. The hypothesis was that there would be no significant differences between the clinical and radiologic outcome parameters of SCR and PR after a minimum follow-up of 2 years.Study Design:Cohort study; Level of evidence, 3.Methods:Of 21 patients who underwent SCR, 20 patients were matched in a 1:1 ratio according to sex, age, and tear configuration with 20 of 60 patients who had undergone PR; all patients were prospectively evaluated for a minimum follow-up of 2 years. The investigated outcome measures included the Constant score; Western Ontario Rotator Cuff (WORC) index; Disabilities of the Arm, Shoulder and Hand (DASH) score; and radiologic analysis of acromiohumeral distance (AHD) and humeral head centralization (HHC).Results:There were no differences in the demographic data between the SCR and PR groups. The mean age of both groups was 62.3 years (range, 47-79 years), the mean tear configuration was Bateman 3.0 and Patte 2.8, and the mean follow-up period was 29.4 months (range, 24-53 months). At final follow-up, no significant differences were seen between the SCR and PR groups with regard to Constant score (77.1 vs 82.7), age- and sex-adapted Constant score (85.5% vs 91.4%), DASH score (15.6 vs 7.8), or WORC index (81.1 vs 90.4). No significant differences in the AHD or HHC were seen between the groups. The reoperation rate was 4.8% (1/21) in the SCR cohort and 15% (9/60) in the PR cohort.Conclusion:Both SCR and PR resulted in significant improvements in patient-reported outcomes at 2-year follow-up, with no significant differences in clinical outcomes between the 2 techniques. Further follow-up is needed to determine whether there are long-term differences in HHC and development of cuff tear arthropathy. Further investigations should also focus on the cost-effectiveness of the respective procedures.

Return to Sport and Athletic Function Following Primary Arthroscopic Labral Reconstruction

To report 2-year clinical outcomes and the return to sport rate in athletic patients who underwent primary hip arthroscopy with labral reconstruction in the setting of femoroacetabular impingement (FAI) syndrome and irreparable labral tears Data were prospectively collected for patients who underwent a labral reconstruction between August 2012 and December 2017. Patients were included if they identified as an athlete (high school, college, recreational, or amateur), had follow-up on the following patient-reported outcomes (PROs): modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), Hip Outcome Score-Sport Specific Subscale (HOS-SSS), visual analog scale (VAS), and completed a return to sport survey at 1-year postoperatively. Patients were excluded if they underwent any previous ipsilateral hip surgery, had dysplasia, or had prior hip conditions. Statistical significance was set at P=0.05. There were 32 (14 females) athletes who underwent primary labral reconstruction during the study period. The mean age and body mass index (BMI) of the group was 40.3 years (15.5–58.7 years) and 27.9 kg/m2 (19.6-40.1 kg/m2), respectively. The mean follow-up time was 26 months (12-64 months). All patients demonstrated significant improvement in mHHS, NAHS, HOS-SSS, and VAS (P < 0.001) at latest follow-up. Additionally, 84.4% achieved MCID and 81.3% achieved PASS for mHHS, and 87.5% achieved MCID and 75% achieved PASS for HOS-SSS. VAS pain scores decreased from 4.4 to 1.8 and the satisfaction with surgery was 7.9 out of 10. The rate of return to sport was 78%, with 40.6% successfully returning to sport at the same or higher level. At average 2-year follow-up, primary arthroscopic labral reconstruction, in the setting of FAI and irreparable labral tears, was associated with significant improvement in PROs in athletic population. The return to sport within 1-year 28 surgery was 78 %, with 40.6% returning to sport at the same or higher level.

Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study.

Introduction:To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).Methods:This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients (n = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. PROs assessed included Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity, patient’s assessment of pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), European Quality of Life-5 Dimensions-5 Level index scores and visual analogue scale, and measures collected in electronic patient daily diaries: duration of morning joint stiffness, Worst Tiredness, and Worst Joint Pain. Treatment comparisons were made with logistic regression and analysis of covariance models for categorical and continuous variables, respectively.Results:Statistically significant (p ⩽ 0.05) improvements in all PROs were observed in the baricitinib 4 mg group compared to placebo as early as week 1 to week 4; and were sustained to week 24. These improvements were maintained until week 52 for the baricitinib group. A significantly larger proportion of patients met or exceeded the minimum clinically important difference for HAQ-DI (⩾0.22) and FACIT-F (3.56) profiles in the baricitinib group.Conclusion:Baricitinib provided significant improvements in PROs compared to placebo to 52 weeks of treatment in patients with RA who had an inadequate response to MTX.Clinicaltrials.gov identifier: https://clinicaltrials.gov/ct2/show/NCT02265705; NCT02265705; RA-BALANCE. Registered 13 October 2014

Hip Arthroscopy Over 70: Post-operative Patient Reported Outcomes at Minimum 1 Year Follow-Up

To report the indications, intra-operative diagnostics, surgical management options and minimum 1-year outcomes in patients ≥70 years old undergoing hip arthroscopy. Data were prospectively collected on patients who underwent hip arthroscopy to treat central (chondrolabral, iliopsoas), peripheral (Cam-type FAI), and peritrochanteric (GT bursitis, gluteus medius/minimus) compartment pathology along with any subsequent revision hip arthroscopies and/or conversion to total hip arthroplasty (THA), between February 2009 and April 2018. The inclusion criteria were ≥70 years old at surgery and minimum 1-year follow-up on the following patient-reported outcomes (PROs): modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), Hip Outcome Score- Sport Specific Subscale (HOS-SSS), and a visual analog scale (VAS) for pain. In addition, the International Hip Outcome Tool (iHOT-12) and the physical and mental portions of the Veterans RAND 12-Item Health Survey (VR-12M and VR-12P) and Short Form 12 (SF-12M and SF-12P) questionnaires were also included. The proportion of patients who achieved the minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) for mHHS was also reported. Of the 59 eligible cases, 48 (81.4%) had minimum 1-year follow-up at a mean of 36.8 months (range, 12.0-116.4 months). Of note, the most common indication was a gluteus medius tear for which 42 of 48 (87.5%) patients underwent peritrochanteric endoscopic gluteus medius repair. Five (10.4%) cases underwent a subsequent surgery, with 3 (6.3%) converting to total hip arthroplasty (THA). Postoperative mHHS scores were significantly increased (72.8 ± 20.8) at latest follow-up. Furthermore, there were 26 (54.2%) patients who demonstrated improvement that surpassed the literature values for the minimal clinically important difference and patient acceptable symptomatic state for mHHS. Regarding NAHS, HOS-SSS, iHOT-12, SF-12P, and VR-12P, patients demonstrated significant improvement following surgery (P < 0.05). In addition, pain on the visual analog scale (out of 10) decreased from 6.1 to 2.2 (P < 0.001). The mean satisfaction with surgery was 7.2 out of 10 at latest follow-up. Hip arthroscopy in patients ≥70 years old demonstrates statistically significant PRO improvements at minimum 1-year follow-up. Most notably, 87.5% of patients underwent peritrochanteric endoscopic gluteus medius repair, which highlights a significant indication for surgical management in this population. The low rate of conversion to THA and high rate of patient satisfaction underscores the potential to help an older patient cohort in need of minimally invasive arthroscopic procedures to relieve hip pain. Surgeons, therefore, should have a high index of suspicion for abductor tendon pathology, in addition to intraarticular sources of pain, when managing this population, and expectations of outcomes should be discussed accordingly.

Structured physical therapy protocols following hip arthroscopy and their effect on patient-reported outcomes-a systematic review of the literature.

The purpose of this study was to analyze the effect of structured physical therapy protocols on patient-reported outcomes (PROs) following hip arthroscopy. A literature search was completed in October 2019 according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines to identify articles reporting specific rehabilitation protocols following hip arthroscopy that document PROs. Studies meeting all inclusion and exclusion were reviewed and data were extracted. Six studies were included in analysis. The mean age was 34.7% and 56.6% were males. Five studies described rehabilitation protocols in phases with specific goals and progression criteria. All studies included range of motion (ROM) and weight-bearing (WB) precautions. Return to sport (RTS)/activity varied between 7 and 32 weeks. The studies used variations of 21 different PROs. Significant improvements in baseline and post-operative PROs noted across studies. Rehabilitation protocols following hip arthroscopy typically consist of 4–5 phase programs with set goals and progression criteria. Several commonalities existed between studies on WB, ROM precautions and gait normalization. However, timing and recommendations for RTS/return to work varied between studies and were dependent on the concomitant procedures performed as well as type of patient population. Clinically significant improvement in PROs from baseline noted in majority of the studies reviewed that involved a structured rehabilitation program following arthroscopic management of femoroacetabular impingement. As there is heterogeneity in patient-specific characteristics across the included studies, no determination can be made as to which protocol is most effective and further high-quality comparative studies are needed.Clinical relevanceAdopting phase-based rehabilitation protocols following arthroscopic femoroacetabular impingement treatment help achieve improved outcomes that are predictable

Survivorship and Patient-Reported Outcomes After Comprehensive Arthroscopic Management of Glenohumeral Osteoarthritis: Minimum 10-Year Follow-up

Background: Few long-term outcome studies exist evaluating glenohumeral osteoarthritis (GHOA) treatment with arthroscopic management. Purpose: To determine outcomes, risk factors for failure, and survivorship for the comprehensive arthroscopic management (CAM) procedure for the treatment of GHOA at minimum 10-year follow-up. Study Design: Case series; Level of evidence, 3. Methods: The CAM procedure was performed on a consecutive series of patients with advanced GHOA who opted for joint preservation surgery and otherwise met criteria for total shoulder arthroplasty. At minimum 10-year follow-up, postoperative outcome measures included change in the American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, 12-Item Short Form Health Survey (SF-12) Physical Component Summary, and visual analog scale for pain, along with the QuickDASH (shortened version of Disabilities of the Arm, Shoulder and Hand) and satisfaction score. Kaplan-Meier survivorship analysis was performed, with failure defined as progression to arthroplasty. Results: In total, 38 CAM procedures were performed with 10-year minimum follow-up (range, 10-14 years) with a mean patient age of 53 years (range, 27-68 years) at the time of surgery. Survivorship was 75.3% at 5 years and 63.2% at minimum 10 years. Those who progressed to arthroplasty did so at a mean 4.7 years (range, 0.8-9.6 years). For those who did not undergo arthroplasty, American Shoulder and Elbow Surgeons scores significantly improved postoperatively at 5 years (63.3 to 89.6; P < .001) and 10 years (63.3 to 80.6; P = .007). CAM failure was associated with severe preoperative humeral head incongruity in 93.8% of failures as compared with 50.0% of patients who did not go on to arthroplasty (P = .008). Median satisfaction was 7.5 out of 10. Conclusion: Significant improvements in patient-reported outcomes were sustained at minimum 10-year follow-up in young patients with GHOA who underwent a CAM procedure. The survivorship rate at minimum 10-year follow-up was 63.2%. Humeral head flattening and severe joint incongruity were risk factors for CAM failure. The CAM procedure is an effective joint-preserving treatment for GHOA in appropriately selected patients, with sustained positive outcomes at 10 years.

Differences in Clinical Presentations and Surgical Outcomes of Gluteus Medius Tears Between Men and Women

Background: Gluteus medius (GM) tears often occur in women aged >50 years. There is a paucity of literature comparing sex-based differences in those undergoing GM repair. Purpose: To report differences between women and men in clinical presentations and patient-reported outcome (PRO) scores at a minimum 2-year follow-up after undergoing GM repair. Study Design: Cohort study; Level of evidence, 3. Methods: Data were prospectively collected and retrospectively reviewed. All included patients had postoperative scores for the following PROs: modified Harris Hip Score (mHHS), Non-arthritic Hip Score (NAHS), Hip Outcome Score–Sports Specific Subscale (HOS-SSS), and International Hip Outcome Tool–12. Men were propensity score matched 1:3 to women according to concomitant arthroscopic procedures and follow-up time. Clinical effectiveness was determined through a uniquely calculated minimal clinically important difference (MCID) for the mHHS and NAHS specific to this study population. Results: Thirteen men were successfully propensity score matched to 39 women. Women and men were 55.87 ± 11.0 and 62.38 ± 11.63 years old (mean ± SD), respectively (P = .02). Men were at increased risk for associated lumbar pathology as compared with women (relative risk, 3.32; P = .02). Women showed significant improvement from preoperative to minimum 2-year follow-up for the mHHS (59.32 ± 15.36 to 83.81 ± 16.82; P < .01), NAHS (56.23 ± 15.61 to 83.78 ± 17.66; P < .01), HOS-SSS (33.35 ± 20.28 to 67.88 ± 32.35; P < .01), and visual analog scale (5.48 ± 2.00 to 1.93 ± 2.29; P < .01). Similarly, men showed significant improvement for the mHHS (63.50 ± 16.41 to 84.77 ± 13.91; P < .01), NAHS (61.52 ± 9.87 to 84.42 ± 14.87; P < .01), HOS-SSS (33.97 ± 21.20 to 63.62 ± 26.20; P < .01), and visual analog scale (4.93 ± 2.69 to 1.86 ± 2.10; P < .01). The MCIDs for the mHHS and NAHS were calculated to be 7.89 and 7.24. Of the women, 28 (72%) and 34 (87%) met the MCID for the mHHS and NAHS. Eleven (85%) men met the MCID for the mHHS and NAHS. Conclusion: These results suggest that women and men can both benefit after GM repair. Men were older and had increased risk for associated lumbar pathology than women at the time of surgery. Men and women both experienced significant improvements in PROs and compared favorably in terms of clinical effectiveness at a minimum 2-year follow-up.

Treatment of Labral Calcification in the Setting of Femoroacetabular Impingement Syndrome With Arthroscopic Calcification Excision, Labral Repair, and Osteoplasty Improves Outcomes

To describe the diagnosis and 2-year outcomes of arthroscopic treatment for labral calcification in the setting of femoroacetabular impingement syndrome (FAIS). A retrospective analysis was performed from a prospectively collected database of patients with FAIS undergoing hip arthroscopy. Patients with FAIS with labral calcification were differentiated radiographically from patients with other paralabral radiopaque densities such as os acetabuli, acetabular rim fractures, and labral ossification. Patients with FAIS with labral calcification were treated with arthroscopic calcification excision, labral repair, and osteoplasty and matched by age, sex, and body mass index with a cohort of patients with FAIS without labral calcifications who underwent labral repair and osteoplasty. Pre- and 2 years postoperatively, patients completed patient-reported outcome (PRO) scores including the modified Harris Hip Score, Hip disability and Osteoarthritis Outcome Score (HOOS), 12-item Short-Form survey, and visual analog scale. In total, 40 hips (21 male, 19 female) with FAIS and labral calcification were included (age 36.8 ± 8.1, body mass index, 25.9 ± 4.5). Patients with FAIS with labral calcification demonstrated similar significant PRO score improvements compared with a matched cohort of patients with FAIS without labral calcification at 2 years after surgery (visual analog scale: (-)2.3 ± 0.4, (-)2.7 ± 0.5, modified Harris Hip Score: 16.1 ± 2.6, 17.1 ± 3.2; HOOS symptoms: 21.9 ± 3.7, 18.6 ± 3.6; HOOS pain: 22.1 ± 3.0, 25.0 ± 3.5; HOOS activities of daily living: 20.2 ± 2.8, 23.8 ± 3.3; HOOS sport: 35.6 ± 5.0, 35.6 ± 4.1; HOOS quality of life: 36.9 ± 4.5, 37.5 ± 4.4; 12-item Short-Form survey physical component summary: 15.5 ± 2.3, 20.1 ± 2.1, respectively). Both cohorts achieved minimal clinically important differences at equivalent rates (60%-82.5%) for all PRO scores. Patients with labral calcification in the setting of FAIS can be effectively treated with arthroscopic calcification excision, labral repair, and osteoplasty. These patients demonstrate significant improvements in patient-reported outcomes and achievement of minimal clinically important differences at 2 years similar to patients undergoing arthroscopic treatment for FAIS without labral calcification. Level III, matched cohort study.

In search of labral restoration function with hip arthroscopy: outcomes of hip labral reconstruction versus labral repair: a systematic review.

To perform a systematic review comparing patient-reported outcomes (PROs) in patients who underwent hip arthroscopy with labral repair versus labral reconstruction in the setting of femoroacetabular impingement syndrome (FAIS) and labral tears. A systematic review of the PubMed, Embase, and Cochrane databases was performed in May 2020 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and checklist. Articles were included in the analysis if they compared PROs between a labral repair and labral reconstruction cohort. For all PROs, the standardised mean difference (SMD) was calculated to compare the effect size of labral repair and labral reconstruction. 10 comparative studies, with 582 reconstruction cases and 631 repair cases, were included in this analysis. The mean age for the reconstruction and the repair groups ranged from 27.0 years to 52.6 years and 27.5 years to 47.0 years, respectively. The mean follow-up for the reconstruction and the repair groups ranged from 24.0 months to 66.0 months and 24.0 months to 71.0 months, respectively. The modified Harris Hip Scores (mHHS) was favourable in 8 reconstruction studies (range 80.4-95.0) and 9 repair studies (range 84.1-93.0). Average NAHS scores for the repair and reconstruction cohorts ranged from 77.9-88.6 and 73.9-92.4, respectively. Additionally, the effect sizes regarding NAHS and mHHS scores were large (SMD > 0.8) in both the reconstruction and repair groups for the majority of studies. Finally, reconstruction patients underwent a subsequent total hip arthroplasty (THA) at a slightly higher rate. In the setting of FAIS and labral tears, patients who underwent hip arthroscopy may expect significant improvement in PROs at short-term follow-up with either labral repair or labral reconstruction. Although, not statistically significant, the repair group trended towards higher scores and exhibited a lower risk of conversion to THA.

Development of an evidence-based approach to the use of acellular dermal matrix in immediate expander-implant-based breast reconstruction

Although acellular dermal matrix (ADM) is widely used in expander-implant-based breast reconstructions, previous analyses have been unable to demonstrate improvements in patient-reported outcomes (PROs) with this approach over non-ADM procedures. This study aims to develop a more selective, evidence-based approach to the use of ADM in expander-implant-based breast reconstruction by identifying patient subgroups in which ADM improved clinical outcomes and PROs. The Mastectomy Reconstruction Outcomes Consortium Study prospectively evaluated immediate expander-implant reconstructions at 11 centers from 2012 to 2015. Complications (any/overall and major), and PROs (satisfaction, physical, psychosocial, and sexual well-being) were assessed two years postoperatively using medical records and the BREAST-Q, respectively. Using mixed-models accounting for centers and with interaction terms, we analyzed for differential ADM effects across various clinical subgroups, including age, body mass index, radiation timing, and chemotherapy. Expander-implant-based breast reconstruction was performed in 1451 patients, 738 with and 713 without ADM. Major complication risk was higher in ADM users vs. nonusers (22.9% vs. 16.4% and p = 0.04). Major complication risk with ADM increased with higher BMI (BMI=30, OR=1.70; BMI=35, OR=2.29, interaction p = 0.02). No significant ADM effects were observed for breast satisfaction, psychosocial, sexual, and physical well-being within any subgroups. In immediate expander-implant-based breast reconstruction, ADM was associated with a greater risk of major complications, particularly in high-BMI patients. We were unable to identify patient subgroups where ADM was associated with significant improvements in PROs. Given these findings and the financial costs of ADM, a more critical approach to the use of ADM in expander-implant reconstruction may be warranted.

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study

BACKGROUND CONTEXTVarious designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series. PURPOSETo evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy. STUDY DESIGN/SETTINGProspective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial. PATIENT SAMPLESubjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF. OUTCOME MEASURESPain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months. METHODSUsing propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls). RESULTSBoth ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups. CONCLUSIONSM6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline.

S0725 Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-Up Results From an Observational Real World Study Among Patients With Inflammatory Bowel Disease (ONWARD Study)

INTRODUCTION: The objective of this study was to describe the effects of infliximab-dyyb, a biosimilar to reference product (RP) infliximab, on clinical and patient-reported outcomes (PROs) in inflammatory bowel disease (IBD) including Crohn’s disease (CD) and ulcerative colitis (UC) patients in a real-world setting. METHODS: In this prospective, observational study, patients with IBD in the US and Canada were recruited to begin treatment with infliximab-dyyb. Patients, divided into biological naive users of infliximab-dyyb (naive users) and those switching from RP infliximab to infliximab-dyyb, were followed for 1 year. Clinical outcomes assessed were partial Mayo score (PMS) and Harvey Bradshaw Index (HBI) for the UC and CD cohort, respectively. Clinical response (PMS/HBI reduction ≥3 points) and remission (PMS <3 or HBI <5) were measured. Patient reported outcomes (PROs) included: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and EuroQol Visual Analog Scale (EQ-VAS). Changes from baseline were assessed using mixed models for repeated measures. Adverse events (overall/treatment-related) were assessed. RESULTS: A total of 67 CD and 48 UC patients initiating treatment with infliximab-dyyb were enrolled (51% female; mean age 44 years; 87% Caucasian; mean BMI 27.9). Of them, 39 patients were naive users, 57 were switched from RP infliximab, and 19 were switched from other biologics. Among UC naïve users, PMS improved (P < 0.0001) and remission rate increased from baseline (P = 0.0015; Table 1). For UC patients switching from RP infliximab to infliximab-dyyb, PMS improved from baseline (P = 0.0103; Table 1). CD naive users and patients switching from RP infliximab had low baseline HBI scores which where maintained over time (Table 2). Among all naïve users, SIBDQ and EQ-VAS scores improved from baseline (P < 0.0001 and 0.0135; Table 3). Patients switching from RP infliximab maintained SIBDQ and EQ-VAS scores (P = 0.1416 and 0.0675; Table 3). Regarding adverse events, 22 occurred related to treatment (including 5 lack of response, 4 infusion reaction, 2 immunogenicity, and 2 hypersensitivity reaction). Overall, 19 (17%) patients discontinued infliximab-dyyb. CONCLUSION: Clinical outcomes among naive users of infliximab-dyyb improved for UC and were maintained for CD patients. Naive users of infliximab-dyyb showed significant improvements in PROs. Patients switching from RP infliximab to infliximab-dyyb maintained their clinical outcomes and quality of life.Table 1Table 2Table 3

Postoperative Outcomes and Complications in Hallux Rigidus: A Comparison Between Polyvinyl Alcohol Implant and Cheilectomy with Moberg Osteotomy

Category:Midfoot/Forefoot; OtherIntroduction/Purpose:In 2016, the US Food and Drug Administration (FDA) approved the use of a polvinvyl alcohol (PVA) hydrogel implant (Cartiva, Elmsford, NY) for surgical treatment of hallux rigidus, or degenerative arthritis of the first metatarsophalangeal (1st MTP) joint. While studies have demonstrated the safety and usability of PVA implant, clinical outcomes following hemiarthroplasty with the PVA have not yet been compared to that of traditional joint-preserving procedures such as cheilectomy with Moberg osteotomy in the treatment of hallux rigidus. The purpose of this study is to compare patient-reported outcomes and postoperative complications between PVA hemiarthroplasty and cheilectomy with Moberg osteotomy, with the hypothesis that the addition of PVA would result in superior clinical outcomes.Methods:Patients were retrospectively identified who underwent hallux rigidus correction by one of seven Foot and Ankle fellowship-trained orthopaedic surgeons between March 2016 and November 2018. Out of 162 patients, a total of 133 patients constituted our study cohort after excluding patients with insufficient follow-up. Of the 133, 60 patients (mean age 57.2 years) were treated with combination PVA, cheilectomy, and Moberg osteotomy (PCM) and 73 patients (mean age 54.1) were treated with cheilectomy and Moberg (CM) alone. Both preoperative as well as minimum 1-year postoperative patient-reported outcome scores (PROMIS) were compared between the two cohorts. Chart review was performed to compare rates of revision and complications.Results:Average time to follow-up was 14.5 months for PCM and 15.6 for CM groups. Both PCM and CM cohorts demonstrated significant improvement in PROMIS scores, with the CM group demonstrating significantly greater increase in Physical Function (7.14 +- 8.48 vs 3.58 +- 6.24, p=0.01). While preoperative scores were comparable, postoperatively the CM group had a significantly higher average Physical Function (51.8 +- 8.7 vs 48.8 +- 8.0, p=0.04) and lower Pain Intensity (39.9 +- 8.3 vs 43.4 +- 8.7, p=0.02). There were 2 cases of revision with re-implantation and 1 case of conversion to arthrodesis in the PCM group. There was 1 case of conversion to PVA in the CM group. Three patients who underwent PCM had a documented postoperative infection requiring antibiotics.Conclusion:Our data suggests that the addition of polyvinyl alcohol implant in the treatment of hallux rigidus results in significant improvement in patient-reported outcomes. However, patient-reported physical function may not be up to par at minimum 1-year follow-up compared to cheilectomy and Moberg osteotomy alone. In addition, while incidence was low in our cohort, revision of the implant as well as conversion to arthrodesis remain possible complications of PVA. Therefore, we believe that proper patient selection is recommended when considering surgical treatment options for hallux rigidus.

The Learning Curve for Hip Arthroscopic Surgery: A Prospective Evaluation With 2-Year Outcomes in Patients With Femoroacetabular Impingement

Background:The use of hip arthroscopic surgery in the treatment of femoroacetabular impingement (FAI) is increasing, but it is universally known as a technically demanding procedure with a “steep” learning curve. There are limited data investigating the correlation between surgeon experience and patient-reported outcomes (PROs) as well as procedure and traction times.Purpose:To prospectively evaluate the relationship between surgeon experience and PROs after hip arthroscopic surgery for the treatment of FAI.Study Design:Cohort study; Level of evidence, 2.Methods:A total of 190 patients undergoing primary hip arthroscopic surgery for FAI were prospectively enrolled during a sports medicine fellowship–trained surgeon’s first 36 months of practice. A radiographic evaluation as well as PRO surveys including the 12-Item Short Form Health Survey (SF-12), the modified Harris Hip Score (mHHS), and the Hip disability and Osteoarthritis Outcome Score (HOOS) were administered preoperatively and at 2 years postoperatively. Logistic regression as well as analysis of variance was performed to evaluate for correlations between surgical experience and PROs, procedure time, and traction time.Results:Of the 190 patients, 168 (88%; mean age, 35.3 ± 9.6 years; mean body mass index, 25.07 ± 3.98) completed a 2-year follow-up and were included for analysis. The mean procedure time was 91.5 ± 23.9 minutes, and the mean traction time was 54.0 ± 17.7 minutes. Patients demonstrated significant improvements at 2 years after surgery for all PRO scores (mHHS, HOOS, and SF-12 physical component summary; P < .001), except the SF-12 mental component summary, which had no change (P = .43). The procedure time significantly decreased after 70 cases, while the traction time continued to decrease until 110 cases (R 2 = 0.99; P < .0001). There was no correlation between increasing case volume and 2-year PRO scores (P > .2 for mHHS, HOOS, and SF-12). There was also no difference with increasing case volume and amount of improvement from preoperative to 2-year postoperative PRO scores for the SF-12 and HOOS. Case volume did not affect the complication rate, as this cohort experienced 4 minor cases of neurapraxia.Conclusion:Surgical efficiency in hip arthroscopic surgery for the treatment of FAI was maximized after 110 cases in this cohort. However, significant PRO improvements can be achieved early in a surgeon’s practice prior to maximizing surgical efficiency.

Arthroscopic management with labral preservation, femoral osteoplasty, and capsular plication in patients with borderline hip dysplasia. Results of a matched-cohort study at minimum twoyear follow-up.

The purpose of this study was to assess intra-operative findings, surgical procedures, and outcomes in a cohort of patients with borderline hip dysplasia treated with arthroscopic labral repair, femoral osteoplasty, and capsular plication, and compare these outcomes with those of a rigorously matched control group without dysplasia. Data were prospectively collected and retrospectively reviewed for patients with a lateral center-edge angle between 20 and 24° who underwent hip arthroscopy surgery between 2014 and 2018. Labral, chondral status, psoas impingement, ligamentum teres, and cam morphology were evaluated. Patient-reported outcomes (PROs) scores included modified Harris Hip Score (mHHS), Hip Outcome Score Activities of Daily Living Subscale (HOS-AVD) and Hip Outcome Score Sport-Specific Subscale (HOS-SSS), and International Hip Outcome Tool-12 (IHOT-12). Clinical relevance was measured with the minimal clinical important difference (MCID), patient acceptable symptom state (PASS), and substantial clinical benefit (SCB). Twenty patients met the inclusion criteria. An age- and sex-matched control group of 40 patients was also selected. Arthroscopic intra-operative findings were similar between cohorts. At a mean follow-up of 50months in the borderline hip dysplasia cohort, and 52months in the control cohort, there was a significant improvement in PROs in both cohorts, and no significant differences could be detected at the latest follow-up. The difference in frequency of patients achieving the MCID, PASS, and SCB was not statistically significant between cohorts. With strict patient selection criteria, hip arthroscopy may be a beneficial approach in patients with borderline hip dysplasia.

Health-related quality-of-life improvement with lumbar fusion in patients with lower-extremity arthritis.

Lumbar fusion can lead to significant improvements in patient-reported outcomes (PROs) in patients with degenerative conditions. It is unknown whether the presence of hip or knee arthritis confounds the responses of patients to low-back-specific PROs. This study examined PROs with lumbar fusion in patients with concomitant lower-extremity arthritis. The purpose of the current study was to examine whether patients with significant lower-extremity arthritis who undergo lumbar fusion achieve similar improvements in low-back-specific PROs compared to patients without lower-extremity arthritis. Patients were identified from a prospectively enrolled multicenter registry of patients undergoing lumbar fusion surgery for degenerative conditions. Two hundred thirty patients identified with lumbar fusion and who also had concomitant lower-extremity arthritis were propensity matched to 233 patients who did not have lower-extremity arthritis based on age, BMI, sex, smoking status, American Society of Anesthesiologists grade, number of levels fused, and surgical approach. One-year improvement in PROs, numeric rating scales (0-10) for back and leg pain, and the Oswestry Disability Index and EuroQol-5D scores were compared for patients with and without lower-extremity arthritis. Baseline demographics and preoperative outcome measures did not differ between the two propensity-matched groups with 110 cases each. Patients with concomitant lower-extremity arthritis achieved similar improvement in health-related quality-of-life measures to patients without lower-extremity arthritis, with no significant differences between the groups (p > 0.10). The presence of lower-extremity arthritis does not adversely affect the results of lumbar fusion in properly selected patients. Patients with lower-extremity arthritis who undergo lumbar fusion can achieve meaningful improvement in PROs similar to patients without arthritis.

P107. Are Modic changes associated with health-related quality of life after discectomy?

BACKGROUND CONTEXT Previous studies have failed to show a clinically significant association between Modic changes (MCs) and patient-reported outcomes (PROs) after discectomy. PURPOSE To assess whether Modic changes (MCs) are associated with health-related quality of life, long-term physical disability, back or leg pain after discectomy. STUDY DESIGN/SETTING A registry-based comparative cohort study with two-year follow-up. PATIENT SAMPLE n=620. OUTCOME MEASURES PROs including ODI, EQ-5D, VAS back and leg pain and patient satisfaction were collected. METHODS Data from the Danish National Spine Registry on patients undergoing first-time lumbar discectomy at a single institution from 2014-17 with an accessible preoperative lumbar MRI, complete preoperative and two-year follow-up questionnaires were obtained. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the preoperative MRI. RESULTS Of 620 patients included, MCs were present in 270 patients (47%). Of these, MC type 1 (MC-1) was present in 70 (25%) and MC type 2 (MC-2) in 210 (75%) patients. Preoperative data for ODI, EQ-5D, VAS-BP, and VAS-LP were comparable for the +MC and -MC groups. Both groups had a statistically significant improvement in PRO's from baseline compared to two-year follow-up (p CONCLUSIONS MCs were not found to be associated with health-related quality of life, disability, back- or leg pain or patient satisfaction two years after discectomy. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.