Improvements In Patient-reported Outcome Measures Research Articles

Prospective Outcomes After Serial Platelet-Rich Plasma (PRP) Injection in Vocal Fold Scar and Sulcus.

Vocal fold scar and sulcus pose significant treatment challenges with no current optimal treatment. Platelet-rich plasma (PRP), an autologous concentration of growth factors, holds promise for regenerating the superficial lamina propria. This study aims to evaluate the potential benefits of serial PRP injections on mucosal wave restoration and vocal function. In a prospective clinical trial across two institutions, patients with vocal fold scar underwent four serial PRP injections, one month apart. Blinded independent laryngologists and expert listeners used pretreatment and one-month post-fourth injection videostroboscopy and CAPE-V assessments to evaluate mucosal wave and voice quality changes, respectively. Additionally, patient reported outcome measures (PROMs) were evaluated. In the study, 15 patients received 55 PRP injections without adverse effects. Eight patients (53.3%) had mild, three patients (20%) had moderate, and four patients (26.7%) had severe scar. There was an average reduction of 8.7 points in post-treatment VHI-10 scores (p = 0.007). The raters observed an improvement in post-treatment voice in 73.4% of cases, and CAPE-V scores showed a reduction of 18.8 points on average (p = 0.036). The videostroboscopic VALI ratings showed an improvement in mucosal wave rating from 2.0 to 4.0. On average, the raters perceived the post-PRP exams to be better in 56.7% of cases. PRP has been validated as a safe autologous option for treatment of vocal fold scar. While results for mucosal wave and voice quality varied, there was a consistent improvement in PROMs. Level 3: Prospective cohort study, with blinded analysis Laryngoscope, 2024.

Impact of preoperative age-adjusted sagittal imbalance on radiographic and clinical outcomes following 1-level minimally invasive transforaminal lumbar interbody fusion for degenerative spondylolisthesis.

Prior studies investigating the use of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) for treatment of degenerative lumbar conditions and concomitant sagittal deformity have not stratified patients by preoperative pelvic incidence (PI)-lumbar lordosis (LL) mismatch, which is the earliest parameter to deteriorate in mild sagittal deformity. Thus, the aim of the present study was to determine the impact of preoperative PI-LL mismatch on clinical outcomes and sagittal balance restoration among patients undergoing MI-TLIF for degenerative spondylolisthesis (DS). Consecutive adult patients undergoing primary 1-level MI-TLIF between April 2017 and April 2022 for DS with ≥ 6 months radiographic follow-up were included. Patient-reported outcome measures (PROMs) included the Oswestry Disability Index, visual analog scale (VAS), 12-Item Short-Form Health Survey (SF-12), and Patient-Reported Outcomes Measurement Information System at preoperative, early postoperative (< 6 months), and late postoperative (≥ 6 months) time points. The minimal clinically important difference (MCID) for PROMs was also evaluated. Radiographic parameters included PI, LL, pelvic tilt (PT), and sagittal vertical axis (SVA). Patients were categorized into balanced and unbalanced groups based on preoperative PI-LL mismatch according to age-adjusted alignment goals. Changes in radiographic parameters and PROMs were evaluated. Eighty patients were included (L4-5 82.5%, grade I spondylolisthesis 82.5%, unbalanced 58.8%). Mean clinical and radiographic follow-up were 17.0 and 8.3 months, respectively. The average preoperative PI-LL was 18.8° in the unbalanced group and -3.3° in the balanced group. Patients with preoperative PI-LL mismatch had significantly worse preoperative PT (26.2° vs 16.4°, p < 0.001) and SVA (53.2 vs 9.0 mm, p = 0.001) compared with balanced patients. Patients with preoperative PI-LL mismatch also showed significantly worse PI-LL (16.0° vs 0.54°, p < 0.001), PT (25.9° vs 18.7°, p < 0.001), and SVA (49.4 vs 22.8 mm, p = 0.013) at long-term follow-up. No significant radiographic improvement was observed among unbalanced patients. All patients demonstrated significant improvements in all PROMs (p < 0.05) except for SF-12 mental component score. Achievement of MCID for VAS back score was significantly greater among patients with preoperative PI-LL mismatch (85.7% vs 65.5%, p = 0.045). Although 1-level MI-TLIF did not restore sagittal alignment in patients with preoperative PI-LL mismatch, patients presenting with DS can expect significant improvement in PROMs following 1-level MI-TLIF regardless of preoperative alignment or extent of correction. Thus, attaining good clinical outcomes in patients with mild sagittal imbalance may not require addressing imbalance directly.

Obesity Does Not Negatively Affect Patient-perceived Outcomes After Cervical Disc Replacement for Disc Herniation.

Retrospective review. To assess the impact of Body Mass Index (BMI) on patient-reported outcome measures (PROMs) after cervical disc replacement (CDR). BMI may affect PROMs after spine surgery. Primary CDR recipients for herniated disc(s) with BMI <40 were retrospectively selected from a single-surgeon registry. Cohorts were divided into non-obese (BMI <30) and obese (BMI ≥30). Intercohort in-hospital complication rates were compared through independent samples t tests. Pre/postoperative PROMs were compared between cohorts through multivariable regression accounting for demographic differences. Final follow-up dates between patients averaged 11.8 ± 9.3 months. PROMs assessed included Patient-reported Outcomes Measurement Information System-Physical Function, Neck Disability Index, Visual Analog Scale-Neck, Visual Analog Scale-Arm, and the 9-item Patient Health Questionnaire. Improvements in PROMs were evaluated and compared at each follow-up within cohorts through paired t tests. The magnitude of improvement in PROMs from preoperative baseline at 6-week follow-up (∆PROM-6W) and final follow-up (∆PROM-FF) along with achievement rates of minimum clinically important differences were compared between cohorts through multivariable regression accounting for demographic differences. Of 153 patients, 53 patients were noted as obese. Demographic differences included age, prevalence of hypertension and diabetes, and comorbidity burden scores ( P ≤ 0.011, all). No significant variations in in-hospital complications were found. The non-obese cohort demonstrated improvements in all PROMs at 6 weeks and final follow-up periods ( P ≤ 0.005, all). The obese cohort demonstrated improvements in all postoperative PROMs besides 9-item Patient Health Questionnaire at 6 weeks ( P ≤ 0.015, all). After accounting for age and comorbidity variations, there were no significant intercohort differences in raw PROM scores, ∆PROM-6W, ∆PROM-FF, or minimum clinically important difference achievement rates. Regardless of BMI, patients experience significant improvements in physical function, disability, pain, and mental health after CDR for disc herniation. Patients with obesity do not suffer inferior patient-perceived outcomes after CDR. These findings may help surgeons counsel patients in the preoperative period.

Thresholds For Diminishing Returns In Postoperative Range Of Motion After Total Shoulder Arthroplasty

BackgroundSatisfaction following shoulder arthroplasty (TSA), which is commonly reported using patient-reported outcome measures (PROMs), is partially dependent upon restoring shoulder range of motion (ROM). We hypothesized there exists a minimum amount of ROM necessary to perform functional tasks queried in PROM questionnaires, beyond which further ROM may provide no further improvement in PROMs. MethodsA retrospective review of a multicenter international shoulder arthroplasty database was performed between 2004-2020 for patients undergoing anatomic or reverse TSA (aTSA, rTSA) with minimum 2-year follow-up. Our primary outcome was to determine the threshold in postoperative active ROM (abduction, forward elevation [FE], external rotation [ER], and internal rotation [IR] score) whereby additional improvement was not associated with additional improvement in PROMs (Simple Shoulder Test [SST], American Shoulder and Elbow Surgeons [ASES] score, and the Shoulder Pain and Disability Index [SPADI]). For comparison, we also evaluated the Shoulder Arthroplasty Smart (SAS) score, which is not subject to the ceiling effect. ResultsWe included 4,459 TSAs (1,802 aTSAs, 2,657 rTSAs) with minimum 2-year follow-up (mean, 56±32 months). The threshold in postoperative ROM that were associated with no further improvement were: active abduction, 107-113° for PROMs versus 163° for the SAS score; active FE, 149-162° for PROMs versus 176° for the SAS score; active ER, 50-52° for PROMs versus 72° for the SAS score; IR score, 4-5 points for all PROMs versus 6 points for the SAS score. Out of 3,508 TSAs with complete postoperative ROM data, 8.5% achieved or exceeded all ROM thresholds (14.5% aTSAs, 4.8% rTSAs). ConclusionsOur findings demonstrate that postoperative ROM exceeding 113° of abduction, 162° of FE, 52° of ER, and IR to L1 is associated with minimal additional improvement in PROMs. While individual patient needs vary, the thresholds may provide helpful targets for patients undergoing postoperative rehabilitation.

Patient-reported Outcomes Following Nonoperative Treatment of Pediatric First‐Time Patellar Dislocation

BackgroundPatellar instability is a common pediatric knee injury. The purpose of this study was to analyze PROMs (patient-reported outcome measures) after non-operative treatment following a first-time pediatric patellar dislocation. MethodsIn this single-center, retrospective study, patients <18 years old between January 2012 and December 2019 with a first-time patellar dislocation were evaluated. From this cohort, we included all those patients who initially underwent non-operative management and followed up for at least 1 year. Measures of patellar height and patellofemoral dysplasia were collected. Patient-reported outcome measures (PROMs) were collected at the initial and follow-up visit. Univariate and multivariate analyses were utilized to determine the rate and risk factors for recurrence and the changes in PROMs. Results176 knees were included in the initial analysis, and 80 in the pre- and post-PROM analysis. There was a 41% rate of recurrence at a mean of 16.4 months of follow-up. In a multivariate logistic regression model, trochlear dysplasia (OR:4.53, 95%CI: 1.61–12.7, P=0.004), patella alta (OR:4.27, 95%CI: 1.76–10.3, P<0.001), and tibial tubercle trochlear groove (TT-TG) > 15mm (OR:2.49, 95%CI: 1.3–6.03, P<0.001) were significant risk factors for recurrence. Patients with or without recurrence showed significant improvements in PROMs at 1 year follow-up. However, both groups had mean scores below the population average. Regardless of recurrence or not, KOOS-Child QoL scores ranked the lowest among all PROM scores at the final follow-up. ConclusionsThe findings of this study provide further evidence of the high rate of recurrent instability and important associated risk factors to consider. We also found that despite the overall improvement in all PROM subscales 1 year following the initial episode, both recurrence and no-recurrence groups demonstrated lower mean PROM scores than normal values. Furthermore, quality of life subscales showed the smallest improvement among all patients. Our results may be used to counsel patients and families regarding expectations after first-time and recurrent patellar dislocations. Key conceptsPatellar instability is one of the most common pediatric sports injuries with a high risk of recurrence.(1)In the absence of other factors, a first-time patellar dislocation is generally treated non-operatively, but the long-term outcomes are not clear.(2)In this study, we found a high risk of recurrent dislocation. In addition, while the PROMs improved for all patients, even patients without evidence of further instability demonstrated patient-reported outcomes lower than the general population.(3)Future research may reveal subtle residual instability or other factors as the reason for the lower functional status and also compare these outcomes with operative reconstruction. Level of evidenceCase series, Level IV

Randomized feasibility study of an autologous protein solution versus corticosteroids injection for treating subacromial pain in the primary care setting - the SPiRIT trial.

The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions' safety and efficacy. Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions. A total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period. Our study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented.

Impact of age on comparative outcomes of decompression alone versus fusion for L4 degenerative spondylolisthesis.

To compare the outcomes of decompression alone and fusion for L4-5 DLS in different age cohorts (< 70years, ≥ 70years). This retrospective cohort study included patients who underwent minimally invasive decompression or fusion for L4-5 DLS and had a minimum of 1-year follow-up. Outcome measures were: (1) patient-reported outcome measures (PROMs) (Oswestry Disability Index, ODI; Visual Analog Scale back and leg, VAS; 12-Item Short Form Survey Physical Component Score, SF-12 PCS), (2) minimal clinically important difference (MCID), (3) patient acceptable symptom state (PASS), (4) response on the global rating change (GRC) scale, and (5) complication rates. The decompression and fusion groups were compared for outcomes separately in the < 70-year and ≥ 70-year age cohorts. 233 patients were included, out of which 52% were < 70years. Patients < 70years showed non-significant improvement in SF-12 PCS and significantly lower MCID achievement rates for VAS back after decompression compared to fusion. Analysis of the ≥ 70-year age cohort showed no significant differences between the decompression and fusion groups in the improvement in PROMs, MCID/PASS achievement rates, and responses on GRC. Patients ≥ 70years undergoing fusion had significantly higher in-hospital complication rates. When analyzed irrespective of the surgery type, both < 70-year and ≥ 70-year age cohorts showed significant improvement in PROMs with no significant difference. Patients < 70years undergoing decompression alone did not show significant improvement in physical function and had significantly less MCID achievement rate for back pain compared to fusion. Patients ≥ 70years showed no difference in outcomes between decompression alone and fusion.

Responder analysis using clinically meaningful thresholds: Post hoc analyses from randomized dupilumab clinical trials in patients with prurigo nodularis.

Prurigo nodularis (PN) is an intensely pruritic disease characterized by itchy nodules on the trunk/extremities; it is often accompanied by skin pain and sleep disruption with negative impacts on the quality of life (QoL). The patient-reported outcome (PRO) instruments, Worst Itch-Numeric Rating Scale (WI-NRS), Skin Pain-NRS, Sleep-NRS and Dermatology Life Quality Index (DLQI) have been psychometrically validated and the clinically meaningful within-patient improvement thresholds (responder definition) have been established through data pooled from the two Phase-3 trials (PRIME, NCT04183335 and PRIME2, NCT04202679) of dupilumab in adults with PN uncontrolled on topical therapies. To estimate the proportion of dupilumab-treated patients (vs. placebo) achieving clinically meaningful improvement in itch, skin pain, sleep and QoL, either alone or in combination, from the data pooled from PRIME and PRIME2 trials. The patient-level data pooled from the two Phase-3 trials (N = 311) were used for this post hoc analysis. Thresholds of clinically meaningful within-patient improvement in PRO instrument scores from baseline at Week 24 used for defining responders were 4 (WI-NRS and Skin Pain-NRS), 2 (Sleep-NRS) and 9 points (DLQI). The proportion of dupilumab-treated patients, versus placebo, achieving the thresholds, and the time taken to achieve the thresholds were evaluated for the individual and combination of PROs. Responder rates were significantly higher with dupilumab, versus placebo at Week 24 for WI-NRS (58.8% vs. 19.0%, p < 0.0001), Skin Pain-NRS (49.7% vs. 20.9%, p < 0.0001), Sleep-NRS (42.5% vs. 23.4%, p < 0.0001) and DLQI (64.7% vs. 22.8%, p < 0.0001). Proportion of patients achieving simultaneous improvement in symptoms and QoL (24.8% vs. 6.3%, p < 0.0001) were significantly higher in dupilumab-treated patients versus placebo. The time needed for achieving clinically meaningful improvement in symptoms were significantly lower in dupilumab-treated patients, versus placebo. Significantly greater proportion of dupilumab-treated patients with PN, versus placebo, demonstrated clinically meaningful improvements in PRO measures of symptoms and QoL.

Morbidly Obese Patients Have Similar Clinical Outcomes and Recovery Kinetics After Minimally Invasive Decompression.

Retrospective cohort. To study the impact of class 2/3 obesity (body mass index, BMI >35) on outcomes following minimally invasive decompression. No previous study has analyzed the impact of class 2/3 obesity on outcomes following minimally invasive decompression. Patients who underwent primary minimally invasive decompression were divided into 4 cohorts based on their BMI: normal (BMI 18.5 to <25), overweight (25 to <30), class 1 obesity (30 to <35), and class 2/3 obesity (BMI >35). Outcome measures were: 1) intraoperative variables: operative time, estimated blood loss (EBL); 2) patient reported outcome measures (PROMs) (Oswestry Disability Index, ODI; Visual Analog Scale, VAS back and leg; 12-Item Short Form Survey Physical Component Score, SF-12 PCS); 3) global rating change (GRC), minimal clinically important difference (MCID), and patient acceptable symptom state (PASS) achievement rates; 4) return to activities; and 5) complication and reoperation rates. 838 patients were included (226 normal, 357 overweight, 179 class 1 obesity, 76 class 2/3 obesity). Class 1 and 2/3 obesity groups had significantly greater operative times compared to the other groups. Class 2/3 obesity group had worse ODI, VAS back and SF-12 PCS preoperatively, worse ODI, VAS back, VAS leg and SF-12 PCS at <6 months, and worse ODI and SF-12 PCS at >6 months. However, they had significant improvement in all PROMs at both postoperative timepoints and the magnitude of improvement was similar to other groups. No significant differences were found in MCID and PASS achievement rates, likelihood of betterment on the GRC scale, return to activities, and complication/reoperation rates. Class 2/3 obese patients have worse PROMs pre- and post-operatively. However, they show similar improvement in PROMs, MCID and PASS achievement rates, likelihood of betterment, recovery kinetics, and complication/reoperation rates as other BMI groups following minimally invasive decompression.

ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY IS ASSOCIATED WITH EARLIER RETURN OF SYMMETRICAL LIMB FUNCTION COMPARED WITH CONVENTIONAL TOTAL KNEE ARTHROPLASTY

IntroductionRobotic-assisted total knee arthroplasty (TKA) has demonstrated significant benefits, including improved accuracy of component positioning compared to conventional jig-based TKA. However, previous studies have often failed to associate these findings with clinically significant improvements in patient-reported outcome measures (PROMs). Inertial measurement units (IMUs) provide a more nuanced assessment of a patient's functional recovery after TKA. This study aims to compare outcomes of patients undergoing robotic-assisted and conventional TKA in the early postoperative period using conventional PROMS and wearable sensors.Method100 patients with symptomatic end-stage knee osteoarthritis undergoing primary TKA were included in this study (44 robotic-assisted TKA and 56 conventional TKA). Functional outcomes were assessed using ankle-worn IMUs and PROMs. IMU- based outcomes included impact load, impact asymmetry, maximum knee flexion angle, and bone stimulus. PROMs, including Oxford Knee Score (OKS), EuroQol-Five Dimension (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), and Forgotten Joint Score (FJS-12) were evaluated at preoperative baseline, weeks 2 to 6 postoperatively, and at 3-month postoperative follow-up.ResultsBy postoperative week 6, when compared to conventional TKA, robotic-assisted TKA was associated with significant improvements in maximum knee flexion angle (118o ± 6.6 vs. 113o ± 5.4; p=0.04), symmetrical loading of limbs (82.3% vs.22.4%; p&lt;0.01), cumulative impact load (146.6% vs 37%; p&lt;0.01), and bone stimulus (25.1% vs 13.6%; p&lt;0.01). Whilst there were no significant differences in PROMs (OKS, EQ-5D-5L, EQ-VAS, and FJS-12) at any time point between the two groups, when comparing OKS subscales, significantly more robotic-assisted TKA patients achieved an ‘excellent’ outcome at 6 weeks compared to conventional (47% vs 41%, p= 0.013).ConclusionsIMU-based metrics detected an earlier return to function among patients that underwent robotic-assisted TKA compared to conventional TKA that PROMs were unable to detect within the first six weeks of surgery.

Temporal Trends of Improvement After Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Retrospective review of prospectively collected data. To analyze temporal trends in improvement after minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Although several studies have shown that patients improve significantly after MIS TLIF, evidence regarding the temporal trends in improvement is still largely lacking. Patients who underwent primary single-level MIS TLIF for degenerative conditions of the lumbar spine and had a minimum of 2-year follow-up were included. Outcome measures were: 1) patient reported outcome measures (PROMs) (Oswestry Disability Index, ODI; Visual Analog Scale, VAS back and leg; 12-Item Short Form Survey Physical Component Score, SF-12 PCS); 2) global rating change (GRC); 3) minimal clinically important difference (MCID); and 4) return to activities. Timepoints analyzed were preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Trends across these timepoints were plotted on graphs. 236 patients were included. VAS back and VAS leg were found to have statistically significant improvement compared to the previous timepoint up to 3 months after surgery. ODI and SF-12 PCS were found to have statistically significant improvement compared to the previous timepoint up to 6 months after surgery. Beyond these timepoints, there was no significant improvement in PROMs. 80% of patients reported feeling better compared to preoperative by 3 months. >50% of patients achieved MCID in all PROMs by 3 months. Most patients returned to driving, returned to work, and discontinued narcotics at an average of 21, 20, and 10 days, respectively. Patients are expected to improve up to 6 months after MIS TLIF. Back pain and leg pain improve up to 3 months and disability and physical function improve up to 6 months. Beyond these timepoints, the trends in improvement tend to reach a plateau. 80% of patients feel better compared to preoperative by 3 months after surgery.

Accuracy of machine learning to predict the outcomes of shoulder arthroplasty: a systematic review

BackgroundArtificial intelligence (AI) uses computer systems to simulate cognitive capacities to accomplish goals like problem-solving and decision-making. Machine learning (ML), a branch of AI, makes algorithms find connections between preset variables, thereby producing prediction models. ML can aid shoulder surgeons in determining which patients may be susceptible to worse outcomes and complications following shoulder arthroplasty (SA) and align patient expectations following SA. However, limited literature is available on ML utilization in total shoulder arthroplasty (TSA) and reverse TSA.MethodsA systematic literature review in accordance with PRISMA guidelines was performed to identify primary research articles evaluating ML’s ability to predict SA outcomes. With duplicates removed, the initial query yielded 327 articles, and after applying inclusion and exclusion criteria, 12 articles that had at least 1 month follow-up time were included.ResultsML can predict 30-day postoperative complications with a 90% accuracy, postoperative range of motion with a higher-than-85% accuracy, and clinical improvement in patient-reported outcome measures above minimal clinically important differences with a 93%–99% accuracy. ML can predict length of stay, operative time, discharge disposition, and hospitalization costs.ConclusionML can accurately predict outcomes and complications following SA and healthcare utilization. Outcomes are highly dependent on the type of algorithms used, data input, and features selected for the model.Level of EvidenceIII

Comparison of transforaminal and posterior lumbar interbody fusion outcomes in patients receiving a novel allograft versus rhBMP-2: a radiographic and patient-reported outcomes analysis.

Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been demonstrated to achieve the highest rates of arthrodesis in multilevel lumbar fusion but is also associated with possible perioperative morbidity. A novel allograft (OSTEOAMP) is a differentiated allograft that retains growth factors supporting bone healing. The authors sought to compare the clinical and radiographic outcomes of rhBMP-2 and the novel allograft in lumbar interbody arthrodesis to determine if the latter may be a safer and equally effective alternative to rhBMP-2 for single- and multilevel posterior or transforaminal lumbar interbody fusion (PLIF or TLIF). Patients who underwent single- or multilevel TLIF or PLIF using either OSTEOAMP or rhBMP-2 at the authors' institution over a 2-year period were prospectively followed for 12 months. Healthcare utilization, safety measures, patient satisfaction, physical disability (measured on the Oswestry Disability Index [ODI]), back and leg pain (on the numeric rating scale [NRS]), quality of life (on the EQ-5D scale), and return to work (RTW) were prospectively recorded. For purposes of this study, this consecutive series was retrospectively analyzed and pseudarthrosis rates were assessed at 2 years of follow-up. All patients (100%) had both 12-month patient-reported outcome follow-up and 24-month clinical and radiographic follow-up. One thousand one hundred fifty-four patients (654 treated with OSTEOAMP, 500 with rhBMP-2) were prospectively enrolled in the institutional registry. After propensity score matching, there were no significant baseline differences between 330 novel allograft and 330 rhBMP-2 cases. Perioperative morbidity and 90-day hospital readmission (3.3% vs 2.4%, p = 0.485) did not significantly differ between the novel allograft and the rhBMP-2 cases. At the 2-year follow-up, symptomatic pseudarthrosis requiring revision surgery occurred in 8 patients (2.4%) with OSTEOAMP and 6 patients (1.8%) with rhBMP-2 (p = 0.589). The overall fusion rate at 2 years was similar between groups (p = 0.213). Both groups showed significant and equivalent improvement in patient-reported outcome measures (PROMs) from baseline to 12-month follow-up, with no significant difference in 1-year mean NRS leg pain score (2.5 vs 2.7), ODI (25 vs 26), quality-adjusted life years (0.73 vs 0.73), satisfaction (83% vs 80%), or RTW (6.6 vs 7 weeks). In the authors' institutional experience, OSTEOAMP is a clinically viable substitute for rhBMP-2 for single- and multilevel lumbar fusion. This novel allograft provides clinically effective arthrodesis and improvements in PROMs comparable to rhBMP-2 with a similar safety profile. Additional indications and outcome assessment in longitudinal studies are needed to further characterize this allogeneic graft.

Cervical Disk Replacement Versus Anterior Cervical Diskectomy and Fusion: Effect of Procedural Variant on Patients With a Prolonged Preoperative Duration of Symptoms From Disk Herniation.

Patients with a prolonged preoperative symptom duration (PSD) in the setting of cervical disk herniation (DH) may suffer inferior outcomes after surgical intervention. Comparison between anterior cervical diskectomy and fusion (ACDF) versus cervical disk arthroplasty (CDA) in this at-risk population has not yet been conducted. Patients undergoing ACDF or CDA for DH with a PSD > 180 days were selected. Six-week (6W) and final follow-up (FF) patient-reported outcome measures (PROMs) as well as magnitude of postoperative improvements (∆PROM) were compared between cohorts using multivariable linear regression. Intercohort achievement rates of minimal clinically important difference (MCID) in each PROM were compared. Seventy-seven of 190 patients were in the CDA cohort. 6W Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) was superior in the CDA cohort. The ACDF cohort demonstrated notable improvements in the 6W Neck Disability Index (NDI), visual analog scale-neck pain (VAS-N), visual analog scale-arm pain (VAS-A), and 9-item Patient Health Questionnaire (PHQ-9). The CDA cohort demonstrated notable improvements in 6W PROMIS-PF, NDI, VAS-N, and VAS-A. FF VAS-A was better in the CDA cohort. The ACDF cohort demonstrated notable improvements in FF PROMIS-PF, NDI, VAS-N, and VAS-A. The CDA cohort demonstrated notable improvements in all FF PROMs. ∆PROM-6W in PROMIS-PF was greater in the CDA cohort. Patients with prolonged PSD due to cervical DH demonstrated notable improvements in physical function, disability, pain, and mental health regardless of fusion versus arthroplasty techniques. Accounting for demographic variations, patients undergoing CDA demonstrated a greater magnitude of improvement and superior scores in physical function at the first postoperative follow-up. Rates of clinically tangible improvements in PROMs did not markedly vary by surgical procedure. Patients undergoing CDA may perceive greater early improvements to physical function compared with patients undergoing ACDF for prolonged PSD due to DH.

How useful are indirect radiographic measurements of hip instability in borderline hip dysplasia? An MRI-based comparison to a healthy cohort

PurposeSymptomatic hips with borderline hip dysplasia (BHD) morphology pose a challenge in differentiating stable from unstable hips. The current study aims to compare indirect radiographic signs of instability in a symptomatic BHD population to those in a healthy cohort.MethodsThe study group consisted of patients with a lateral centre–edge angle (LCEA) with values 18° ≤ LCEA < 25° who underwent corrective periacetabular osteotomy (PAO) and reported an improvement in patient-reported outcome measures (PROMs). The comparison group consisted of a healthy cohort of athletes who did not complain of any hip-related symptoms and who had normal values of their hip morphological parameters (LCEA, acetabular index (AI°), alpha angle (α°), femoral version, acetabular version). Indirect signs of instability consisting of the femoro-epiphyseal acetabular roof index (FEAR), iliocapsularis-to-rectus-femoris (IC/RF) ratio and labral dimensions (height-to-length ratio) were assessed in both groups. Partial Pearson correlation, logistic multiple regression analysis and Receiver-Operating Characteristic (ROC) curve analysis were performed to determine correlations, as well as the sensitivity and specificity of these signs to differentiate between healthy hips and BHD.ResultsOn binary logistic multiple regression analysis, the FEAR Index was the only independent predictor to differentiate between BHD and healthy hips (p < 0.001). The IC/RF ratio did not achieve significance. The calculated area under the curve (AUC) was 0.93 (0.87 – 0.99, CI 95%, p < 0.001) for the FEAR Index and 0.81 (0.70 – 0.92, CI 95%, p < 0.001) for the height-length ratio. Using the predefined cut-off values (dysplastic—FEAR Index ≥ 5° or labral height-to-length ratio ≤ 0.5), 27% sensitivity/100% specificity and 20% sensitivity/ 100% specificity, were achieved. ROC analysis provided the following new thresholds: FEAR Index ≥ -5° (73% sensitivity/97% specificity); labral height-to-length ratio ≤ 0.8 (70% sensitivity, 79% specificity).ConclusionIn our cohort, the FEAR index was an independent parameter that could differentiate between borderline dysplastic and asymptomatic hips. The previously published values for both the FEAR index and labral hypertrophy ratio had a poor sensitivity in differentiating symptomatic unstable BHD from healthy hips. The cut-off values of ≥ -5° (FEAR index) and ≤ 0.8 (labral height-to-length ratio) provided acceptable sensitivity and specificity when comparing to morphological healthy hips.

Impact of Depression and Anxiety on Patient Reported Outcomes Measures after Lumbar Fusion

Depression and anxiety are common in patients undergoing spinal surgery and might negatively impact outcomes. This study investigates the possible effect of these diagnoses on patient reported outcomes following lumbar fusion. Retrospective review of a registry containing prospectively collected data of lumbar fusion procedures at a single institution was performed from May 23, 2012 to June 15, 2022. Patients with a minimum of two year follow-up were included. Demographic information, diagnoses, medications, patient-reported outcomes measures (PROMs), and complications data at preoperative, three months, six months, 1 year, and two years postoperative were collected. Statistical analysis was performed using Student's t-tests, χ2, binomial correlation, odds ratios, logistic regression, and mean clinically important difference. A total of 156 patients were included (60 males, 96 females) with mean age 62.6±11.1years at surgery. Thirty-nine (25%) had depression and/or anxiety (DA). Baseline Oswestry Disability Index (ODI) and EuroQol Group 5D questionnaire (EQ5D) scores were significantly worse in the DA cohort compared to controls (ODI 51.1±18.3 vs. 42.9±15.8; P= 0.010, EQ5D 0.46±0.21 vs. 0.57±0.21; P= 0.005). Both cohorts experienced similar relative improvement at two years (delta ODI-18.2±27.9 vs.-17.8±22.1; P= 0.924, EQ5D 6.8±33.8 vs. 8.1±32.9; P= 0.830). Absolute outcome scores were worse in the DA cohort at all intervals. DA were not independently predictive of changes in PROMs (delta ODI mean difference 4.49, r2=0.36, P= 0.924). The present study showed similar improvement in PROMs following lumbar fusion for patients with anxiety and depression compared to healthy controls. These data suggest these patients are no less likely to benefit from appropriately planned lumbar fusion.

The evolution of patient-reported outcome measures after a first lateral ankle sprain: A prospective study

PurposeA lateral ankle sprain is the most common musculoskeletal injury in the physically active population. However, it is unclear how the clinical condition evolves during the period after the injury and what proportion of patients develops chronic symptoms. Therefore, the purpose of this study is to assess the evolution of patient-reported outcome measures after a first time lateral ankle sprain. MethodsA prospective clinical study assessed the patient-reported outcome measures (PROMs) of a consecutive group of 100 patients during 1 year after a first lateral ankle sprain. The Karlsson score and Foot and Ankle Outcome Score (FAOS) were assessed at 6 weeks, 3 months, 6 months, 9 months and 1 year. The Cumberland Ankle Instability Tool (CAIT)-score was assessed at 6 months, 9 months and 1 year. The difference between the time points of all scores was analysed using the positive change over time (binomial test versus 50%) and the difference in score (signed rank test). The time to sustained excellent level was also assessed overall and in several subgroups: age, gender, degree of injury (2 or 3), avulsion fracture, use of crutches, use of cast. Differences between subgroups were assessed by a generalized log-rank test. ResultsAll clinical scores demonstrated an improvement up to 12 months after the sprain. The median Karlsson score (interquartile range) improved from 62 (50−80) at 6 weeks to 90 (72−100) at 3 months, to 97 (82−100) at 6 months to 100 (90−100) at 9 months, to 100 (100−100) at 1 year. The analysis of positive change over time demonstrated a significant positive change (P-value <.0005) between all time points except between 6 weeks and 12 weeks when using the FAOS quality score. The difference in score demonstrated a significant change (P-value <.01) between all time points except between 36 weeks and 48 weeks when using the FAOS pain and FAOS sports score. Age and presence of an avulsion fracture were correlated with a slower recovery and worse results. At 1 year, in total 13 patients (13%) had a worse outcome corresponding to a Karlsson score < 81 or CAIT score < 24. ConclusionThe clinical condition after a first ankle sprain demonstrated a significant improvement in PROMs between the different time points in the first year. Twelve months after a first lateral ankle sprain 13% had a fair or poor outcome. Higher age and presence of an avulsion fracture were correlated with a slower recovery and worse results. This information is useful in clinical practice to predict further progression and inform patients. Moreover, it is valuable to improve treatment strategies. Level of evidenceLevel II (prospective cohort study)

Eptinezumab for the preventive treatment of episodic and chronic migraine: a narrative review.

Eptinezumab, a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), was recently approved in Europe for the prophylactic treatment of migraine in adults who have at least four migraine days a month. Eptinezumab is administered by intravenous infusion every 12 weeks. During recent months, a considerable amount of evidence from eptinezumab trials has been published. The aim of this review is to describe the existing evidence on the tolerability, safety and efficacy of eptinezumab in patients with migraine. Data from randomized (PROMISE-1, PROMISE-2, RELIEF and DELIVER) and open-label (PREVAIL) phase 3 clinical trials have demonstrated the favorable effect of eptinezumab in migraine symptoms from first day of treatment. These studies showed that eptinezumab results in an overall reduction in mean monthly migraine days (MMDs), increases in the ≥50% and ≥ 75% migraine responder rates (MRRs) and improvements in patient-reported outcome measures in both patients with episodic migraine (EM) and with chronic migraine (CM), including patients who failed previous preventive treatments. The RELIEF trial also showed that eptinezumab, within 2 h of administration, reduced headache pain, migraine-associated symptoms and acute medication use when administered during a migraine attack. Eptinezumab benefits manifested as early as day 1 after dosing and with the subsequent doses lasted up to at least 2 years. Treatment-emergent adverse events reported by ≥2% of patients included upper respiratory tract infection and fatigue. Current evidence demonstrates that eptinezumab has a potent, fast-acting, sustained migraine preventive effect in patients with EM and CM. Eptinezumab has also shown to be well tolerated, supporting its use in the treatment of patients with migraine and inclusion in the current migraine therapeutic options.

Excellent 2-Year Outcomes of a Midlevel Constrained Liner Used in Stemless Primary TKA

Introduction: Instability after total knee arthroplasty (TKA) remains a leading cause of revision TKA and can lead to patient dissatisfaction. While many companies have developed midlevel constrained (MLC) polyethylene inserts in primary TKAs, there is little data on their outcomes. Purpose: We sought to analyze short-term outcomes including survivorship, rates of manipulation under anesthesia (MUA), and improvements in patient-reported outcome measures (PROMs) preoperatively to postoperatively in one design of MLC TKA. Methods: We prospectively followed consecutive primary TKA patients who received constrained inserts (Journey II or Legion Genesis II, Smith and Nephew) from 5 surgeons, 2019 to 2020, at a single academic institution. We analyzed revision-free survivorship, MUA rates, and PROMs, preoperatively to postoperatively. Results: A total of 356 patients were included with a mean age of 64 years; 49% were male and the mean body mass index (BMI) was 31 kg/m2. Sixteen patients (4.5%) underwent MUA and 3 patients (0.8%) underwent revision. Two patients underwent polyethylene exchange and patellar resection for patellar loosening. One patient underwent liner exchange for instability. The 2-year revision-free survivorship was 98.5% (95% confidence interval [CI]: 96.6%–100%). Survivorship free from revision for tibial or femoral aseptic loosening was 100% at 2 years. The 2-year survivorship free from MUA was 92.3% (95% CI: 88.6%–96.1%). The mean Knee Osteoarthritis and Injury Outcomes Score Joint Replacement (KOOS JR) was 81 at 2 years follow-up, while the Lower Extremity Activity Score (LEAS) score was 10.5. Conclusion: At a mean of 3 years follow-up, 2 types of MLCs used in primary TKA were associated with a low rate of early revision, low rate of MUA, and reliable improvement in functional outcomes. These MLCs were not associated with early loosening or unique failure modes.

Outcomes of Image-Free Robotic Assisted Total Knee Arthroplasty in Patients Who Have Valgus Knee Deformities

BackgroundValgus knee deformities pose a unique challenge in total knee arthroplasty (TKA) due to the complexity of achieving ligamentous balance and satisfactory alignment compared to varus or neutral deformities. Robotic-assisted (RA) TKA could aid in achieving improved component alignment and balance. MethodsWe retrospectively evaluated a matched cohort of patients to compare image-free RA-TKA (n = 44) versus conventional manual (CM) TKA (n = 30) techniques in patients who have valgus deformity of 5 to 15 degrees, including radiographic and patient-reported outcomes measures (PROMs) over a 3-year period. The patient reported outcome measures (PROMs) studied to determine outcomes were: Western Ontario McMaster University Arthritis Index, Knee Society Score-Function Score, and Short Form 12-item Survey. ResultsOverall, the RA-TKA cohort showed faster improvement in PROMs (37.16 ± 1 8.8 versus 25.74 ± 17.7, P = .02), shorter length of stay (1.41 versus 2.29 days, P = .02), and shorter operating room times (120.79 versus 123.67 minutes, P = .02) than CM-TK). Additionally, there was no difference in the use of primary versus varus-valgus constrained polyethylene liners between the cohorts. ConclusionsIn this investigation, RA-TKA yielded a slightly faster patient recovery, more objective measurements of ligamentous balance, and proved noninferior PROMs compared to CM-TKA for preoperative valgus knee deformities.