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Does the addition of Patient-Reported Outcome Measure Information System (PROMIS) pain instruments improve the sensitivity of PROMIS upper extremity scores after arthroscopic rotator cuff repair?

Alben, Matthew G; Romeo, Paul V; Papalia, Aidan G; Cecora, Andrew J; Kwon, Young W; Rokito, Andrew S; Zuckerman, Joseph D; Virk, Mandeep S
BACKGROUND:Although Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (P-UE) has been validated in upper extremity orthopedics, its ability to capture a patient's functional recovery after arthroscopic rotator cuff repair (aRCR), as measured by its responsiveness, is minimal in the early postoperative period. The primary purpose of this study is to determine if the addition of PROMIS Pain Intensity (P-Intensity) or Pain Interference (P-Interference) scores to PROMIS UE improves the responsiveness throughout the 1-year postoperative period after aRCR. METHODS:This prospective, longitudinal study included 100 patients who underwent aRCR. Patients completed P-UE, P-Interference, P-Intensity, American Shoulder and Elbow Surgeons, and Western Ontario Rotator Cuff Index scores preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. Responsiveness at each time point relative to preoperative baseline and 1-way analysis of variance with post hoc analysis was conducted for each PROM. The responsiveness of the outcome score was determined using the effect size, graded as small (0.2), medium (0.5), or large (0.8). The Pearson correlation coefficient (r) was determined between these instruments at each time point. RESULTS:In isolation, P-UE, P-Interference, and P-Intensity showed a medium-large ability to detect change (positive and negative) throughout the 1-year postoperative period. The addition of PROMIS pain scores to P-UE improved the responsiveness of the instrument (from medium to a large effect size) starting at 3 months and continued throughout the 12-month follow-up period. Although the addition of pain scores increases the response burden for PROMIS, this was still lower than the response burden for the legacy outcome scores (P < .05). CONCLUSION/CONCLUSIONS:The addition of PROMIS pain instruments improves the responsiveness of the P-UE function score in patients undergoing aRCR.
PMID: 39098383
ISSN: 1532-6500
CID: 5730402

Safety and efficacy of second-generation all-suture anchors in labral tear arthroscopic repairs: prospective, multicenter, 1-year follow-up study

Wallace, Andrew L; Calvo, Emilio; Ardèvol Cuesta, Jordi; Lanzetti, Riccardo; Luengo-Alonso, Gonzalo; Rokito, Andrew S; Spencer, Edwin E; Spoliti, Marco
BACKGROUND/UNASSIGNED:This study's primary aim was to assess the safety and performance of second-generation all-soft suture anchors following arthroscopic labral tear repair. METHODS/UNASSIGNED:This prospective, multicenter study was conducted by 6 surgeons at 6 sites in Europe and the United States between November 2018 and August 2020. Patients who required shoulder arthroscopic repair, for a range of labral injuries, were treated with a second-generation all-soft suture anchor. The primary outcome was clinical success rate (percentage of patients without signs of failure and/or reintervention) at 6 months. Secondary outcomes included clinical success rate at 12 months, intraoperative anchor deployment success rate, and patient-reported outcomes (PROs) at 6 and 12 months, including visual analog scale (VAS) pain assessment, VAS satisfaction assessment, EQ-5D-5L Index Score, EQ-5D-5L VAS Health Score, Rowe Shoulder Score for Instability, American Shoulder and Elbow Surgeons score, and Constant-Murley Shoulder Score. Serious adverse events and serious adverse device effects were collected throughout the study. RESULTS/UNASSIGNED:Forty-one patients were enrolled (mean age, 28.2 years; 87.8% male, 12.2% female). Clinical success was achieved in 27/28 and 31/32 patients at 6 months and 12 months, respectively. Anchor deployment had a 100% success rate. Significant improvements over baseline were reported for all PROs except Constant-Murley Shoulder (6 months) and VAS Satisfaction Score (12 months). One patient experienced 1 serious adverse event and 1 patient experienced 1 serious adverse device effect. CONCLUSION/UNASSIGNED:Second-generation all-soft suture anchors used in this study demonstrated a high clinical success rate, a favorable safety profile, and patients exhibited significant improvement in PROs.
PMCID:11258834
PMID: 39035662
ISSN: 2666-6383
CID: 5723422

Clinical outcomes of open Latarjet-Patte procedures performed for recurrent anterior shoulder instability with primary bone loss versus failed arthroscopic Bankart repair

Gambhir, Neil; Papalia, Aidan G; Alben, Matthew G; Romeo, Paul; Larose, Gabriel; Gyftopoulos, Soterios; Rokito, Andrew S; Virk, Mandeep S
BACKGROUND:This study compares the outcomes of Latarjet-Patte procedures (LPs) performed for primary glenohumeral instability in the setting of critical bone loss (LP-BL) versus salvage surgery performed after a failed arthroscopic Bankart repair (LP-FB). METHODS:LP's performed by senior author from 2017 to 2021 were separated into cohorts by LP indication. Data abstracted from electronic medical records included demographic information, preoperative clinical scores, radiological imaging, and complications. Postoperative clinical outcome scores collected after a 2-year minimum follow-up included: patient-reported outcomes measurement information system (PROMIS) upper extremity (UE), PROMIS pain interference, PROMIS pain intensity, American Shoulder and Elbow Surgeons (ASES), and visual analog scale pain scores. RESULTS:A total of 47 patients (LP-BL: n=29, LP-FB: n=18) with a mean age of 29 years (range, 15-58 years) were included in this study. Both cohorts achieved good upper extremity functionality without significant differences as indicated by mean PROMIS UE (LP-BL: 52.6±10.0 vs. LP-FB: 54.6±7.6, P=0.442) and ASES score (LP-BL: 89.9±15.7 vs. LP-FB: 91.5±14.4, P=0.712). However, the LP-FB cohort reported lower levels of pain (LP-FB: 0.5±1.1 vs. LP-BL: 1.9±2.7, P=0.020) at their latest follow-up. There were no significant differences in complication rates including re-dislocation between cohorts (LP-BL: 2/29 [6.9%] vs. LP-FB: 2/18 [11.1%], P=0.629). CONCLUSIONS:When performed after failed Bankart repair, the LP results in similar postoperative functional outcomes and similar rates of complications and re-dislocations when compared to the primary indication of recurrent glenohumeral instability in the setting of critical bone loss. Level of evidence: III.
PMCID:11181068
PMID: 38738330
ISSN: 2288-8721
CID: 5733552

Trends in Elbow Ulnar Collateral Ligament Repairs and Reconstructions and an Analysis Between Low- and High-Volume Surgical Centers: A 10-Year Study in New York State

Bi, Andrew S; Lin, Charles C; Anil, Utkarsh; Rokito, Andrew S; Jazrawi, Laith M; Erickson, Brandon J
BACKGROUND/UNASSIGNED:Elbow ulnar collateral ligament (UCL) reconstruction (UCLR) is the gold standard for operative treatment of UCL tears, with renewed interest in UCL repairs. PURPOSE/UNASSIGNED:To (1) assess trends in rates of UCLR and UCL repair and (2) identify predictors of complications by demographic, socioeconomic, or surgical center volume factors. STUDY DESIGN/UNASSIGNED:Descriptive epidemiology study. METHODS/UNASSIGNED:Patients who underwent UCLR or UCL repair at New York State health care facilities between 2010 and 2019 were retrospectively identified; concomitant ulnar nerve procedures among the cohort were also identified. Surgical center volumes were classified as low (<99th percentile) or high (≥99th percentile). Patient information, neighborhood socioeconomic status quantified using the Area Deprivation Index, and complications within 90 days were recorded. Poisson regression analysis was used to compare trends in UCLR versus UCL repair. Multivariable regression was used to determine whether center volume, demographic, or socioeconomic variables were independent predictors of complications. RESULTS/UNASSIGNED:= .011). CONCLUSION/UNASSIGNED:A rising incidence of UCL repair compared with UCLR was found in New York State, especially among female patients, older patients, and nonprivate payers. There were no differences in 3-month complication rates between high- and low-volume centers, and Medicaid insurance status was a predictor for overall complications within 90 days of operation.
PMCID:11128166
PMID: 38799547
ISSN: 2325-9671
CID: 5663252

Cannabidiol for Postoperative Pain Control After Arthroscopic Rotator Cuff Repair Demonstrates No Deficits in Patient-Reported Outcomes Versus Placebo: 1-Year Follow-up of a Randomized Controlled Trial

Alaia, Michael J; Li, Zachary I; Chalem, Isabel; Hurley, Eoghan T; Vasavada, Kinjal; Gonzalez-Lomas, Guillem; Rokito, Andrew S; Jazrawi, Laith M; Kaplan, Kevin
BACKGROUND/UNASSIGNED:Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes. PURPOSE/UNASSIGNED:To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up. STUDY DESIGN/UNASSIGNED:Randomized controlled trial; Level of evidence, 2. METHODS/UNASSIGNED:test and Fisher exact test, respectively. RESULTS/UNASSIGNED: = .79). CONCLUSION/UNASSIGNED:Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome. REGISTRATION/UNASSIGNED:NCT04672252 (ClinicalTrials.gov identifier).
PMCID:10846110
PMID: 38322981
ISSN: 2325-9671
CID: 5632632

Comparison of Multiple Surgical Treatments for Massive Irreparable Rotator Cuff Tears in Patients Younger Than 70 Years of Age: A Systematic Review and Network Meta-analysis

Bi, Andrew S; Anil, Utkarsh; Colasanti, Christopher A; Kwon, Young W; Virk, Mandeep S; Zuckerman, Joseph D; Rokito, Andrew S
BACKGROUND/UNASSIGNED:Massive irreparable rotator cuff tears (MIRCTs) remain a challenging treatment paradigm, particularly for nonelderly patients without pseudoparalysis or arthritis. PURPOSE/UNASSIGNED:To use a network meta-analysis to analyze comparative studies of surgical treatment options for MIRCTs in patients <70 years of age for several patient-reported outcomes, range of motion (ROM), and acromiohumeral distance (AHD). STUDY DESIGN/UNASSIGNED:Network meta-analysis of comparative studies; Level of evidence, 3. METHODS/UNASSIGNED:package Version 0.9-6 in R. RESULTS/UNASSIGNED:= .024). CONCLUSION/UNASSIGNED:For patients <70 years with MIRCT without significant arthritis or pseudoparalysis, it appears that graft interposition repair techniques, superior capsular reconstruction using the long head of the biceps tendon, arthroscopic debridement, and balloon arthroplasty provide superiority in various outcome domains, while RSA provides the least benefit in forward flexion.
PMID: 38291995
ISSN: 1552-3365
CID: 5627572

Effect of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers on need for operative intervention for idiopathic adhesive capsulitis

Bi, Andrew S; Papalia, Aidan G; Romeo, Paul V; Schoof, Lauren H; Kwon, Young W; Rokito, Andrew S; Zuckerman, Joseph D; Virk, Mandeep S
BACKGROUND/UNASSIGNED:The exact pathogenesis of idiopathic adhesive capsulitis (IAC) is not fully understood, but an inflammatory profibrotic cascade, largely mediated by transforming growth factor-beta 1 (TGF- β1) has been implicated. Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACE-Is) both decrease the activity of TGF-β1. The aim of this study was to determine the impact of ACE-Is or ARBs use on the need for operative intervention in IAC. METHODS/UNASSIGNED:This was a retrospective cohort study of patients from a single institutional database with IAC, divided into two cohorts, with and without ACE-I and/or ARB use as the primary exposure and a minimum 2-year follow-up. The primary outcome measured was the incidence of operative intervention including manipulation under anesthesia (MUA) and arthroscopic capsular release (ACR). Additional multivariable logistic regression analysis was performed to evaluate associations between ACE-I/ARB use and likelihood of undergoing an operative procedure. RESULTS/UNASSIGNED: < .001) demonstrating reduced odds as compared to patients aged <30 years. CONCLUSION/UNASSIGNED:Patients with IAC have an overall low (2.4%) rate of requiring surgical intervention. While the antifibrotic mechanism of ACE inhibitors and ARBs did not significantly affect the rate of requiring surgical intervention, male gender, obesity, younger age, and diabetes, all increased the risk for operative intervention. Losartan, specifically, may have a disease modifying effect on IAC that should be investigated with larger controlled trials.
PMCID:10499842
PMID: 37719830
ISSN: 2666-6383
CID: 5735192

Effects of increased body mass index on one year outcomes following soft tissue arthroscopic shoulder instability repair

Papalia, Aidan G; Romeo, Paul V; Gambhir, Neil; Alben, Matthew G; Chowdhury, Tas; Simcox, Trevor; Rokito, Andrew; Virk, Mandeep S
BACKGROUND/UNASSIGNED:The purpose of this study was to investigate the impact of high body mass index on the 1-year minimal outcome following arthroscopic shoulder stabilization. METHODS/UNASSIGNED:Patients who underwent arthroscopic Bankart repair (ABR) between 2017 and 2021 were identified and assigned to 1 of 3 cohorts based on their preoperative body mass index: normal (18-25), overweight (25-30), and obese (>30). The primary outcomes assessed were postoperative shoulder instability and revision rates. The 3 groups were compared using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity, pain interference, pain intensity, Clinical Global Impression scores, visual analog scale pain scores, and shoulder range of motion at 1 year postoperatively. RESULTS/UNASSIGNED: > .05). CONCLUSION/UNASSIGNED:Obesity is an independent risk factor for longer operative times but does not confer a higher risk of recurrent instability, revision surgery, or lower outcome scores 1 year following ABR.
PMCID:10499852
PMID: 37719813
ISSN: 2666-6383
CID: 5735182

Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper extremity PROMIS scores following arthroscopic rotator cuff repairs

Alben, Matthew G; Gordon, Dan; Gambhir, Neil; Kim, Matthew T; Romeo, Paul V; Rokito, Andrew S; Zuckerman, Joseph D; Virk, Mandeep S
PURPOSE/OBJECTIVE:To calculate and determine what factors are associated with achieving the Minimal Clinically Important Difference (MCID) and the Substantial Clinical Benefit (SCB) of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Testing v2.0 (UE), Pain Interference (P-Interference), and Pain Intensity (P-Intensity) in patients undergoing arthroscopic rotator cuff repair (aRCR). METHODS:The change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve analysis was used to calculate the anchor-based MCID and SCB. To assess the responsiveness of each PROM, effect sizes and standardized response means (SRM) were calculated. To identify factors associated with attaining the MCID and SCB, univariate and multivariate logistic regression analyses were performed. RESULTS:A total of 323 patients with an average age of 59.9 ± 9.5 were enrolled in this study, of which, 187/323 [57.9%] were male and 136/323 [42.1%] were female. The anchor-based MCID for PROMIS UE, P-Interference, and P-Intensity was: 9.0, 7.5, and 11.2, respectively. The respective SCB was 10.9, 9.3, and 12.7. Effect size and SRM were: PROMIS UE (1.4, 1.3), P-Interference (1.8, 1.5), and P-Intensity (2.3, 2.0). Lower preoperative P-Intensity scores (p = 0.02), dominant arm involvement (p = 0.03), and concomitant biceps tenodesis (p = 0.03) were associated with patients achieving the SCB for PROMIS UE. CONCLUSION/CONCLUSIONS:A large responsiveness for each of the PROMIS instruments due to the majority of patients reporting great improvement after aRCR and a small standard deviation across all outcome measures was shown in our study. Lower preoperative P-Intensity scores and concomitant biceps tenodesis were associated with higher odds of achieving the SCB for PROMIS UE. The knowledge of MCID and SCB values for PROMIS instruments will allow the surgeon to determine whether the improvements in the PROMIS scores after aRCR are clinically meaningful. LEVEL OF EVIDENCE/METHODS:Level III.
PMID: 36622420
ISSN: 1433-7347
CID: 5399362

Excellent Correlation of the Patient-Reported Outcomes Measurement Information System Upper Extremity Score With Legacy Outcome Scores Preoperatively and at 1 Year After Arthroscopic Rotator Cuff Repair

Gordon, Dan; Pines, Yaniv; Alben, Matthew G; Ben-Ari, Erel; Rokito, Andrew S; Kwon, Young W; Zuckerman, Joseph D; Virk, Mandeep S
PURPOSE/UNASSIGNED:To assess the preoperative and postoperative performance of the Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS-UE, version 2.0) outcome score in comparison to the American Shoulder and Elbow Surgeons (ASES) and Western Ontario Rotator Cuff Index (WORC) instruments in patients undergoing rotator cuff repair. METHODS/UNASSIGNED:) between these tools was calculated at each time point. Correlations were graded as excellent (>0.7), excellent-good (0.61-0.7), good (0.4-0.6), or poor (<0.4). Responsiveness to change was assessed using the effect size and the standardized response mean. Floor and ceiling effects for each instrument were also assessed. RESULTS/UNASSIGNED:The PROMIS-UE instrument showed good to excellent correlation with the legacy instruments at all time points. There were variations in the measured effect sizes of the various instruments, with the PROMIS-UE instrument showing responsiveness to change at 3 and 12 months but the ASES and WORC instruments showing responsiveness at 6 weeks, 3 months, and 12 months. Both PROMIS-UE and ASES scores displayed ceiling effects at 12 months. CONCLUSIONS/UNASSIGNED:The PROMIS-UE instrument shows excellent correlation with the ASES instrument and a rotator cuff-specific outcome instrument-the WORC instrument-preoperatively and at 1 year after arthroscopic rotator cuff repair. Variations in the measured effect sizes at different postoperative time points and high ceiling effects of the PROMIS-UE instrument at the 1-year time point may limit its utility in the early postoperative phase and at long-term follow-up after rotator cuff repair. CLINICAL RELEVANCE/UNASSIGNED:The performance of the PROMIS-UE outcome measure after arthroscopic rotator cuff repair was investigated.
PMCID:10123413
PMID: 37101887
ISSN: 2666-061x
CID: 5465272