Scaffold- and graft-based biological augmentation of rotator cuff repair: an updated systematic review and meta-analysis of preclinical and clinical studies for 2010-2022.

BACKGROUND: Despite advancements in the surgical techniques of rotator cuff repair (RCR), there remains a high retear rate. Biological augmentation of repairs with overlaying grafts and scaffolds may enhance healing and strengthen the repair construct. This study aimed to investigate the efficacy and safety of scaffold-based (nonstructural) and overlay graft-based (structural) biological augmentation in RCR (excluding superior capsule reconstruction and bridging techniques) in both preclinical and clinical studies. METHODS: This systematic review was performed in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, as well as guidelines outlined by The Cochrane Collaboration. A search of the PubMed, Embase, and Cochrane Library databases from 2010 until 2022 was conducted to identify studies reporting the clinical, functional, and/or patient-reported outcomes of ≥1 biological augmentation method in either animal models or humans. The methodologic quality of included primary studies was appraised using the Checklist to Evaluate a Report of a Non-pharmacological Trial (CLEAR-NPT) for randomized controlled trials and using the Methodological Index for Non-randomized Studies (MINORS) for nonrandomized studies. RESULTS: A total of 62 studies (Level I-IV evidence) were included, comprising 47 studies reporting outcomes in animal models and 15 clinical studies. Of the 47 animal-model studies, 41 (87.2%) demonstrated biomechanical and histologic enhancement with improved RCR load to failure, stiffness, and strength. Of the 15 clinical studies, 10 (66.7%) illustrated improvement in postoperative clinical, functional, and patient-reported outcomes (eg, retear rate, radiographic thickness and footprint, and patient functional scores). No study reported a significant detriment to repair with augmentation, and all studies endorsed low complication rates. A meta-analysis of pooled retear rates demonstrated significantly lower odds of retear after treatment with biological augmentation of RCR compared with treatment with non-augmented RCR (odds ratio, 0.28; P < .00001), with low heterogeneity (I2 = 0.11). CONCLUSIONS: Graft and scaffold augmentations have shown favorable results in both preclinical and clinical studies. Of the investigated clinical grafts and scaffolds, acellular human dermal allograft and bovine collagen demonstrate the most promising preliminary evidence in the graft and scaffold categories, respectively. With a low risk of bias, meta-analysis revealed that biological augmentation significantly lowered the odds of retear. Although further investigation is warranted, these findings suggest graft and scaffold biological augmentation of RCR to be safe.

Local Intraoperative Marrow-Derived Augmentation for Primary Rotator Cuff Repair: An Updated Systematic Review and Meta-analysis of Studies From 2010 to 2022.

Background: Recurrent tears of the rotator cuff pose a substantial problem despite advances in repair technique. Biologic augmentation via marrow stimulation or vented anchors may strengthen the suture-tendon junction and improve healing rates of native tissue, thereby enhancing outcomes of primary surgical repair. Purpose: To provide a focused systematic review and meta-analysis of local, intraoperative marrow-derived augmentation techniques in clinical primary rotator cuff repair. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review of PubMed, Embase, and Cochrane was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A total of 2131 studies from 2010 to 2022, focused on either marrow stimulation or vented anchors, were isolated and classified as either preclinical or clinical. Meta-analysis was performed for comparative marrow stimulation and vented anchor studies. Heterogeneity was tested through calculation of I 2. Results: A total of 13 clinical studies were included in the review. All 9 comparative studies included in the meta-analysis demonstrated high methodologic quality or a low risk of bias. The pooled retear rate across all 9 clinical studies for patients undergoing marrow stimulation was 11%. For the 5 studies in the meta-analysis, the pooled retear rates were 15% for marrow stimulation and 30% for controls. Meta-analysis demonstrated a significant difference in the overall retear rate that favored marrow stimulation (odds ratio [OR], 0.41; 95% CI, 0.25-0.66; P = .0003; I 2 = 0%). Similarly, meta-analysis of the Constant score at final follow-up demonstrated a statistically significant difference between the 2 groups that favored a higher Constant score in the marrow stimulation group (mean difference, 2.84; 95% CI, 1.02-4.66; P = .002; I 2 = 29%). Vented anchors demonstrated improved ossification and bone density at the anchor site, but no difference in outcomes or retear. Pooled retear rates were 22.5% for vented anchors and 27.8% for controls. Conclusion: Current evidence demonstrates that marrow-stimulation techniques may have a positive impact on healing and retear rate, while vented anchors have a muted impact relative to nonvented anchors. Although available evidence is limited and more research is needed, findings to date suggest that marrow stimulation techniques may be an inexpensive, straightforward technique to consider in qualifying patients to prevent rotator cuff retears.

Incidence of primary anatomic and reverse total shoulder arthroplasty in patients less than 50 years of age and high early revision risk.

BACKGROUND: Compared with the overall incidence of shoulder arthroplasty (SA), the relative risk and burden of revision may vary among patients specifically 40-50 years of age and less than 40 years of age. Our aim was to investigate the incidence of primary anatomic total SA and reverse SA, rate of revision within 1 year, and determine the associated economic burden in patients younger than 50 years. METHODS: A total of 509 patients less than 50 years old who underwent SA were included, using a national private insurance database. Costs were based on the grossed covered payment. Multivariate analyses were performed to identify risk factors associated with revisions within 1 year of the index procedure. RESULTS: SA incidence in patients less than 50 years old increased from 2.21 to 2.5 per 100,000 patients from 2017 to 2018. The overall revision rate was 3.9% with a mean time to revision of 96.3 days. Diabetes was a significant risk factor for revision (P = .043). Surgeries performed in patients less than 40 years old cost more than those performed in patients aged 40-50 years for both primary ($41,943 ± $23,842 vs. $39,477 ± $20,874) and revision cases ($40,370 ± $21,385 vs. $31,669 ± $10,430). CONCLUSIONS: This study demonstrates that the incidence of SA in patients less than 50 years old is higher than previously reported in the literature and most commonly reported for primary osteoarthritis. Given the high incidence of SA and subsequent high early revision rate in this subset population, our data portend a large associated socioeconomic burden. Policymakers and surgeons should use these data for implementing training programs focused on joint sparing techniques.

Evidence for Utilization of Injectable Biologic Augmentation in Primary Rotator Cuff Repair: A Systematic Review of Data From 2010 to 2022.

Background: Biologic healing after rotator cuff repair remains a significant challenge. Injectable biologic augmentation may improve tissue quality at the suture-tendon interface. Purpose: To investigate the effect of injectable biologic supplementation in rotator cuff repair and to assess the quality and adherence to evolving reporting standards. Study Design: Systematic review; Level of evidence, 3. Methods: A systematic review was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Included were 40 studies: 29 preclinical (in vivo animal models) and 11 clinical. Each clinical study was assessed for quality, risk of bias, and adherence to relevant MIBO (Minimum Information for Studies Evaluating Biologics in Orthopaedics) guidelines. The outcomes of interest were reported load to failure, load to gap, gap size, and stiffness in the preclinical studies, and healing rate and any patient-reported outcome measures in the clinical studies. Results: Injectables reported included growth factors (eg, transforming growth factor-beta 3, erythropoietin), bone marrow-derived mesenchymal stem cells and adipose-derived mesenchymal stem cells (ADSCs), and other agents such as platelet-rich plasma (PRP) and hyaluronic acid. The most common findings for preclinical injectables were increased load to failure (16/29 studies; 55.2%) and improved collagen histological quality (11/29 studies; 37.9%). All 11 clinical studies (10 PRP, 1 ADSC) indicated no adverse events, with similar or improved patient-reported outcomes compared with repairs in the control groups. In 1 study utilizing an innovative delivery technique, a concentrated PRP globule with fibrin matrix was shuttled over a suture to maintain concentrated PRP at the repair site and demonstrated a significant decrease in retears (P = .03) at a 31-month follow-up. A matched-cohort study investigating augmentation with ADSCs demonstrated a significantly lower retear rate in the ADSC-augmented group than the control group at a 28-month follow-up (P < .001). On average, the clinical studies adhered to 66% of relevant MIBO reporting guidelines and had a low risk of bias. Conclusion: Approximately 83% of preclinical studies found a positive biomechanical or histological effect, with no studies showing an overall negative effect. Clinically, utilization of innovative delivery techniques may reduce the risk of arthroscopic washout of PRP and improve retear rates. ADSCs were shown to reduce retear rates at a 28-month follow-up.

Return to Sport After Anterior Cruciate Ligament Reconstruction Requires Evaluation of >2 Functional Tests, Psychological Readiness, Quadriceps/Hamstring Strength, and Time After Surgery of 8 Months.

PURPOSE: The purpose of this study was to examine the factors commonly used to determine readiness for return to sport (RTS) in the ACL reconstruction (ACL-R) patient population and assess which were most influential to successfully returning to sport and avoiding re-tear. METHODS: The PUBMED, EMBASE and Cochrane Library databases were queried for studies related to RTS in ACL-R. Inclusion and exclusion criteria were applied to identify studies with greater than 1-year outcomes detailing the rate of return and re-tear given a described RTS protocol. Data of interest were extracted, and studies were stratified based on level of evidence and selected study features. Meta-analysis or subjective synthesis of appropriate studies was used to assess more than 25 potentially significant variables effecting RTS and re-tear. RESULTS: After initial search of 1503 studies, 47 articles were selected for inclusion in the final data analysis, including a total of 1432 patients (31.4% female, 68.6% male). A meta-analysis of re-tear rate for included Level of Evidence 1 studies was calculated to be 2.8%. Subgroups including protocols containing a strict time until RTS, strength testing, and ≥2 dynamic tests demonstrated decreased RTS and re-tear heterogeneity from the larger group. Time to RTS, strength testing, dynamic functional testing, and knee stability were also found to be among the most prevalent reported criteria in RTS protocol studies. CONCLUSIONS: This study suggests a multifactorial clinical algorithm for successful evaluation of RTS. The "critical criteria" recommended by the authors to be part of the postoperative RTS criteria include time since surgery of 8 months, use of >2 functional tests, psychological readiness testing, and quadriceps/hamstring strength testing in addition to the modifying patient factors of age and female gender. LEVEL OF EVIDENCE: Level IV, systematic review of Level I-IV studies.

Erratum: The Big Data Gap: Asymmetric Information in the Ophthalmology Residency Match Process and the Argument for Transparent Residency Data.

[This corrects the article DOI: 10.1055/s-0043-1777413.].

A validated algorithm using current literature to judge the appropriateness of anatomic total shoulder arthroplasty utilizing the RAND/UCLA appropriateness method.

BACKGROUND: Currently, appropriateness criteria evaluating when to perform total shoulder arthroplasty (TSA) is lacking. In the absence of society guidelines and limited quality evidence, the RAND/University California in Los Angeles (UCLA) method provides a suitable alternative to evaluate appropriateness and assist in clinical decision making. Given the rise in utilization, appropriateness criteria for TSA have the potential to be an extremely powerful tool for improving quality of care and controlling costs. Thus, the goal of this study was to test explicit criteria to assess the appropriateness of TSA decision making using the RAND/UCLA appropriateness method. METHODS: A review of recent scientific literature to gather available evidence about the use, effectiveness, efficiency, and the risks involved in surgical intervention was performed by a shoulder/elbow fellowship trained physician. Based on pertinent variables including age, rotator cuff status, previous surgical management, mobility, symptomatology, and imaging classifications, 186 clinical scenarios were created. Appropriateness criteria for TSA were developed using a modified Delphi method with a panel consisting of American Shoulder and Elbow Surgeons (ASES) members. A second panel of ASES members rated the same scenarios, with reliability testing performed to compare groups. RESULTS: Panel members reached agreement in 40 (64%) indications. TSA was appropriate in 15 (24%) of indications. For patients with severe symptomatology, TSA was often appropriate for patients aged <75 years and inconclusive or inappropriate for patients aged >75 years. Among patients aged <65 years, TSA varied between appropriate and inconclusive, often dependent on Walch classification. For patients with moderate symptomatology, TSA was inappropriate or inconclusive for patients aged <65 or >75 years. When compared to the second panel's results, moderate agreement was obtained with a weighted kappa statistic of 0.56. CONCLUSIONS: Using the RAND/UCLA method, ASES members created an appropriateness decision tree for pertinent patient variables. This presents the data in a manner that streamlines the clinical decision-making process and allows for rapid and more reliable determination of appropriateness for practitioners. The decision tree is based on a combination of clinical experience from high-volume ASES-member surgeons and a comprehensive review of current evidence. This tool can be used as part of a broader set of factors, including individual patient characteristics, prior studies, and expert opinion, to inform clinical decision making, improve quality of care, and control costs.