Reporting of Demographics & Subgroup Analyses in Premarketing Studies of FDA Approved High-Risk Cardiovascular Devices, 2014-2022.

Background: Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses. Methods: We reviewed all FDA Premarket Approvals for high-risk cardiovascular devices from 2014 to 2022, focusing on pivotal studies supporting device approval. We abstracted detailed demographic data about the age, sex, race, ethnicity, and socioeconomic position of study participants. We also assessed the presence and results of subgroup analyses to understand the safety and effectiveness of devices across trial populations. Results: Analysis of 92 pivotal studies revealed that age and sex were reported in 96.7% of the studies, while race and ethnicity were reported in 71.7% and 58.7%, respectively. However, only 7.9% of studies explicitly detailed the participation of older adults (≥65 years) and no studies reported patients' socioeconomic position. Subgroup analyses by sex were conducted in 70.7% of studies, with 12.3% reporting significant differences. In contrast, analyses by race and ethnicity were performed in only 12.0% of the studies, with 9.1% reporting significant differences. Conclusion: Approximately one-third of pivotal studies for high-risk cardiovascular devices approved by the FDA from 2014 to 2022 did not report the race of study participants, nearly 40% did not report ethnicity, and more than 90% did not report the participation of older adults (≥65 years). Subgroup analyses were infrequently conducted by age or race and ethnicity. There is a need for better trial demographic reporting and conduct of subgroup analyses in premarketing studies to ensure the safety and effectiveness of medical devices for all patients.

Management of Failed Rotator Cuff Repairs: A Review.

Failed rotator cuff repairs present a complex issue for treating surgeons. Many methods of management exist for this pathology including revision repair with biologic augmentation, repairs with allograft, tendon transfers, superior capsular reconstruction, balloon arthroplasty, bursal acromial reconstruction, and reverse total shoulder arthroplasty. This review discusses the current literature associated with these management options.

Clinical Outcomes following Biologically Enhanced Demineralized Bone Matrix Augmentation of Complex Rotator Cuff Repair.

Complex rotator cuff tears provide a significant challenge for treating surgeons, given their high failure rate following repair and the associated morbidity. The purpose of this study is to evaluate the clinical outcomes of patients who underwent biologically enhanced demineralized bone matrix augmentation of rotator cuff repairs. Twenty patients with complex rotator cuff tears underwent arthroscopic rotator cuff repair by a single surgeon with demineralized bone matrix (DBM) augmentation that was biologically enhanced with platelet-rich plasma and concentrated bone marrow aspirate. Post-operative MRI was used to determine surgical success. Patient reported outcome measures and range of motion data were collected pre-operatively and at the final post-operative visit for each patient. Ten patients (50%) with DBM augmentation of their arthroscopic rotator cuff repair were deemed non-failures. The failure group had less improvement of visual analogue pain scale (p = 0.017), Simple Shoulder Test (p = 0.032), Single Assessment Numerical Evaluation (p = 0.006) and abduction (p = 0.046). There was no difference between the groups for change in American Shoulder and Elbow Society score (p = 0.096), Constant-Murley score (p = 0.086), forward elevation (p = 0.191) or external rotation (p = 0.333). The present study found that 50% of patients who underwent biologically enhanced DBM augmentation of their rotator cuff repair demonstrated MRI-determined failure of supraspinatus healing.

Subacromial bursa increases the failure force in a mouse model of supraspinatus detachment and repair.

BACKGROUND: It has been shown that subacromial bursa (SAB) harbors connective tissue progenitor cells. The purpose of this study was to evaluate the effects of implantation of SAB-derived cells (SBCs) suspended in a fibrin sealant bead and implantation of SAB tissue at rotator cuff repair site on biomechanical properties of the repair in a mouse (C57Bl/6) model of supraspinatus tendon (ST) detachment and repair. METHODS: Part 1: Murine SAB tissue was harvested and cultured. Viability of SBCs suspended in 10 µL of fibrin sealant beads was confirmed in vitro and in vivo. Eighty mice underwent right ST detachment and repair augmented with either fibrin sealant bead (control group) or fibrin sealant bead with 100,000 SBCs (study group) applied at the repair site. Part 2: 120 mice underwent right ST detachment and repair and were randomized equally into 4 groups: (1) a tissue group, which received a piece of freshly harvested SAB tissue; (2) a cell group, which received SBCs suspended in fibrin sealant bead; (3) a fibrin sealant group, which received plain fibrin sealant bead without cells; and (4) a control group, which received nothing at the ST repair site. An equal number of mice in each group were killed at 2 and 4 weeks. Specimens underwent biomechanical testing to evaluate failure force (part 1 and 2) and histologic analysis of the repair site (part 1 only). RESULTS: Part 1: The mean failure force in the study group was significantly higher than controls at 2 and 4 weeks (3.25 ± 1.03 N vs. 2.43 ± 0.56 N, P = .01, and 4.08 ± 0.99 N vs. 3.02 ± 0.8 N, P = .004, respectively). Mean cell density of the ST at the repair site was significantly lower in the study group at 2 weeks than in controls (18,292.13 ± 1706.41 vs. 29,501.90 ± 3627.49, P = .001). Study group specimens had lower proteoglycan contents than controls, but this difference was not statistically significant. Part 2: There was no difference in failure force between cell and tissue groups at the 2- and 4-week time points (P = .994 and P = .603, respectively). There was no difference in failure force between fibrin sealant bead and control groups at the 2- and 4-week time points (P = .978 and P = .752, respectively). CONCLUSION: This study shows that the application of SBCs and SAB tissue at the rotator cuff repair site increases the strength of repair in a murine model of rotator cuff detachment and repair.

Knee Medial Collateral Ligament Augmentation With Bioinductive Scaffold: Surgical Technique and Indications.

The medial collateral ligament (MCL) is the most commonly injured ligament of the knee; however, only a minority of cases require surgical intervention. Classically, isolated grade I and II MCL injuries are treated nonoperatively whereas isolated grade III injuries may be treated with surgery. High-grade MCL injuries are frequently associated with concomitant knee ligamentous injuries, particularly the anterior cruciate ligament. Nonetheless, MCL repair or reconstruction is generally reserved for patients with persistent valgus instability after failed nonoperative management. Synthetic and biological implants are increasing in popularity to augment repairs and reconstructions for biomechanical reinforcement and promotion of the native healing response to hasten rehabilitation. The BioBrace (Biorez, New Haven, CT) is a bioinductive scaffold composed of highly porous type I collagen and bioresorbable poly(L-lactide) microfilaments, providing an environment for soft-tissue regeneration and mechanical support. The purpose of this article is to describe the surgical technique and relative indications for the BioBrace in knee MCL ligament repairs and reconstructions.

Augmentation of Distal Biceps Tendon Ruptures With the Lacertus Fibrosus: A Biomechanical Study in a Tendon-Deficient Model.

BACKGROUND: Chronic distal biceps tendon ruptures may require tendon graft augmentation secondary to tendon attrition or retraction. The lacertus fibrosus is a local, cost-effective graft that can be used to supplement reconstruction. PURPOSE: To compare the biomechanical strength of distal biceps tendon repairs with and without lacertus fibrosus augmentation in a tendon-deficient cadaveric model. STUDY DESIGN: Controlled laboratory study. METHODS: Sixteen fresh-frozen matched cadaveric pairs of elbows were randomized into 2 groups: (1) standard distal biceps tendon repair and (2) tendon-deficient (50% step cut) repair with lacertus fibrosus augmentation. All repairs were completed using an oval bone trough and 2 double-loaded No. 2 braided nonabsorbable sutures in a locked Krackow fashion tied over a lateral bone bridge. For the lacertus augmentation group, the lacertus was wrapped circumferentially in a tubular fashion around the tendon to restore the native size and incorporated into the Krackow suture. All specimens underwent cyclic loading and then were loaded to failure. Displacement, stiffness, load to failure, and mode of failure were recorded. RESULTS: The standard repair and lacertus augmentation groups had similar displacements on cyclic loading (1.66 ± 0.62 vs 1.62 ± 0.58 mm, respectively; P = .894). The stiffness was significantly greater for the standard repair group (21.3 ± 2.5 vs 18.5 ± 3.5 N/mm; P = .044). Both groups provided excellent mean peak load to failure strengths, despite the standard repair group having significantly greater strength (462.4 ± 140.5 vs 377.3 ± 101.1 N; P = .022). The primary mode of failure in the standard repair group was fracture at the bone bridge (n = 5/8) compared with suture pullout (n = 4/8) in the lacertus augmentation group. CONCLUSION: Lacertus fibrosus augmentation of a tendon-deficient biceps repair was less stiff and had lower mean load to failure compared with repair of the native tendon in this cadaveric model, but these values remained biomechanically acceptable above critical thresholds. Consequently, lacertus fibrosus augmentation is a viable option for chronic distal biceps tendon ruptures with tendon attrition. CLINICAL RELEVANCE: Chronic distal biceps tendon ruptures may require autograft or allograft reconstruction secondary to tendon scarring, shortening, attrition, and degeneration. The lacertus fibrosus is a cost-effective and low-morbidity local autograft that can be used to augment repairs.

Biologically Augmented Suture for Ligament Bracing Procedures Positively Affects Human Ligamentocytes and Osteoblasts In Vitro.

PURPOSE: The purpose was to evaluate the response of human ligamentocytes and osteoblasts after biological augmentation with thrombin, concentrated bone marrow aspirate (cBMA), or platelet-rich plasma (PRP) on two different types of nonresorbable flat braided suture used for ligament bracing. METHODS: Uncoated (U) and collagen-coated (C) flat braided suture material was augmented with either thrombin (T), cBMA (B), PRP (P), or a combination of these three (A), while platelet-poor plasma was used as a source for fibrin (F) in each assay. Previously cultured ligamentocytes and osteoblasts were added with a defined density and assayed after the required time period for adhesion, proliferation, and alkaline phosphatase activity. RESULTS: Biological augmentation of uncoated [(UFT, UFBT, UFA; P < .001), (UFPT; P = .017)] and collagen-coated suture (CFT, CFPT, CFBT, CFA; P < .001) led to a significantly higher ligamentocyte adhesion. Significantly higher adhesion was also observed for osteoblasts (UFT, UFPT, UFBT, UFA; P < .001; CFT, CFPT, CFBT, CFA; P < .001). Similarly, ligamentocyte proliferation was significantly higher [(UFT, UFPT, UFA; P = .009), (UFBT; P = .001), (CFT; P = .009), (CFBT; P = .001), and (CFA; P = .01)]. Osteoblasts showed significantly higher proliferation as well [(UFT, UFPT, UFA; P = .002), (UFBT; P = .001); (CFT: P = .003), and (CFPT, CFBT, CFA; P = .001)]. Augmentation with thrombin, PRP, and BMA for uncoated (UFT; P = .006, UFPT; P = .035, UFBT; P = .001) and BMA for coated suture (CFBT; P = .027) led to significantly higher alkaline phosphatase activity. CONCLUSION: Biological enhancement of suture used for ligament bracing significantly increased ligamentocyte and osteoblast adhesion and proliferation, as well as alkaline phosphatase activity of osteoblasts in an in vitro model. After biological augmentation, cellular adhesion, proliferation, and alkaline phosphatase activity changed up to 1,077%, 190%, and 78%, respectively. Furthermore, no overall superiority between uncoated or collagen-coated suture material was observed for cellular adhesion, proliferation, or alkaline phosphatase activity. CLINICAL RELEVANCE: This study provides in vitro data on a new treatment concept of biologic augmentation for acute ligamentous lesions treated with ligament bracing that has not been widely described. This concept may improve the healing of injured ligaments, in addition to providing immediate biomechanical stabilization.

Arthroscopic rotator cuff repair with biologically enhanced patch augmentation.

OBJECTIVE: The purpose of this guide is to illustrate an arthroscopic rotator cuff repair (RCR) with two techniques for biologically enhanced patch augmentation. INDICATIONS: Massive rotator cuff tears (> 5 cm) and revision RCR. CONTRAINDICATIONS: Active joint or systemic infection; severe fatty muscle atrophy; severe glenohumeral arthropathy; American Society of Anesthesiologists Physical Status (ASA PS) IV. SURGICAL TECHNIQUE: Dermal allograft patch augmented with concentrated bone marrow aspirate (cBMA), platelet-rich plasma (PRP) and platelet-poor plasma (PPP); or Regeneten patch augmented with bursa, PRP, PPP, and autologous thrombin. POSTOPERATIVE MANAGEMENT: A 30° abduction sling for 6 weeks; unrestricted active-assisted external rotation and forward elevation after 12 weeks; focus on restoration of scapular stability and strength. RESULTS: A total of 22 patients received revision massive RCR using a dermal allograft patch enhanced with cBMA and PRP with a mean follow-up of 2.5 years (1.0-5.8 years). There was a significant improvement in the preoperative Simple Shoulder Test (SST). There was also a trend towards improved pain and American Shoulder and Elbow Surgeons (ASES) Shoulder Score. In this cohort, 45% reached the minimal clinically important difference (MCID), 41% achieved substantial clinical benefit (SCB), and 32% had a patient-acceptable symptomatic state (PASS) for the ASES score. Preliminary data using the Regeneten patch technique with bursa, PRP, PPP, and autologous thrombin was prospectively collected in five patients between 05/2020 and 03/2021 at the author's institution. Mean follow-up was 6.5 ± 1.3 (6-8 months). There was an improvement from preop to postop in pain, ASES, SANE, Constant-Murley (CM) score and active range of motion.

Minimum 10-Year Clinical Outcomes After Arthroscopic 270° Labral Repair in Traumatic Shoulder Instability Involving Anterior, Inferior, and Posterior Labral Injury.

BACKGROUND: Current literature reports highly satisfactory short- and midterm clinical outcomes in patients with arthroscopic 270° labral tear repairs. However, data remain limited on long-term clinical outcomes and complication and redislocation rates in patients with traumatic shoulder instability involving anterior, inferior, and posterior labral injury. PURPOSE: To investigate, at a minimum follow-up of 10 years, the clinical outcomes, complications, and recurrent instability in patients with 270° labral tears involving the anterior, inferior, and posterior labrum treated with arthroscopic stabilization using suture anchors. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A retrospective outcomes study was completed for all patients with a minimum 10-year follow-up who underwent arthroscopic 270° labral tear repairs with suture anchors by a single surgeon. Outcome measures included pre- and postoperative Rowe score, American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test, visual analog scale for pain, and Single Assessment Numeric Evaluation (SANE). Western Ontario Shoulder Instability Index (WOSI) scores were collected postoperatively. Complication data were collected, including continued instability, subluxation or dislocation events, and revision surgery. Failure was defined as any cause of revision surgery. RESULTS: In total, 21 patients (mean ± SD age, 27.1 ± 9.6 years) with 270° labral repairs were contacted at a minimum 10-year follow-up. All outcome measures showed statistically significant improvements as compared with those preoperatively: Rowe (53.9 ± 11.4 to 88.7 ± 8.9; P = .005), ASES (72.9 ± 18.4 to 91.8 ± 10.8; P = .004), Simple Shoulder Test (8.7 ± 2.4 to 11.2 ± 1.0; P = .013), visual analog scale (2.5 ± 2.6 to 0.5 ± 1.1; P = .037), and SANE (24.0 ± 15.2 to 91.5 ± 8.3; P = .043). The mean postoperative WOSI score at minimum follow-up was 256.3 ± 220.6. Three patients had postoperative complications, including a traumatic subluxation, continued instability, and a traumatic dislocation, 2 of which required revision surgery (14.2% failure rate). CONCLUSION: Arthroscopic repairs of 270° labral tears involving the anterior, inferior, and posterior labrum have highly satisfactory clinical outcomes at 10 years, with complication and redislocation rates similar to those reported at 2 years. This suggests that repairs of extensile labral tears are effective in restoring and maintaining mechanical stability of the glenohumeral joint in the long term.

Arthroscopic Rotator Cuff Repair Augmented with Autologous Subacromial Bursa Tissue, Concentrated Bone Marrow Aspirate, Platelet-Rich Plasma, Platelet-Poor Plasma, and Bovine Thrombin.

As recurrent rotator cuff tears following repair remain a significant problem, improving healing potential using biologic adjuvants, including concentrated bone marrow aspirate (cBMA), platelet-rich plasma (PRP), or subacromial bursa tissue (SBT), has become increasingly popular in recent years. In an attempt to combine the benefits of these various biologic adjuvants and maximize the healing potential of the repaired tendon, an arthroscopic rotator cuff repair technique biologically augmented with autologous SBT, cBMA, PRP, platelet-poor plasma (PPP), and bovine thrombin has been developed. The created clot is used as a biologic scaffold for sufficient delivery, and it is stabilized using bovine thrombin in order to ensure maximum stability and retainment of the applied biologic augments at the repair site. CLASSIFICATIONS: I: shoulder; II: rotator cuff.

Clinical and Functional Outcomes After Operative and Nonoperative Treatment of Distal Biceps Brachii Tendon Ruptures in a Consecutive Case Series.

BACKGROUND: Patients with ruptures of the distal biceps brachii tendon (DBBT) have traditionally been treated via surgical repair, despite limited patient data on nonoperative management. PURPOSE/HYPOTHESIS: To determine the clinical and functional outcomes for patients with partial and complete DBBT injuries treated nonoperatively or surgically through an anatomic single-incision technique. We hypothesized that there would be no difference in outcomes in patients treated with nonoperative or operative management. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A retrospective chart review identified all patients with a partial or complete DBBT injury sustained between 2003 and 2017. Surgically treated patients underwent DBBT repair using an anatomic single-incision technique. Nonoperative management consisted of formal physical therapy. The following clinical outcome measures were included for analysis: American Shoulder and Elbow Surgeons (ASES) score; the Disabilities of the Arm, Shoulder and Hand (DASH) upper extremity patient questionnaire; the Single Assessment Numeric Evaluation (SANE) score; and the 36-Item Short Form Health Survey. RESULTS: A total of 60 patients (mean ± SD age, 47.8 ± 11.5 years; range, 18-70 years) sustained DBBT ruptures (38 complete and 22 partial) during the study period. Of patients with complete DBBT, 34 were treated operatively and 4 nonoperatively; of those with partial DBBT, 11 were treated operatively and 11 nonoperatively. At a mean follow-up of 5.4 ± 4.0 years (range, 0.5-16.6 years), patients with complete DBBT ruptures achieved overall similar improvements with respect to mean ASES pain, ASES function, SANE, and DASH scores, regardless of whether they were treated operatively or nonoperatively. Subjective satisfaction and functional scores were comparable between the groups. Similarly, at a mean follow-up of 4.1 ± 3.8 years (range, 0.5-11.3 years), patients with partial DBBT injuries had improved mean ASES pain, ASES function, SANE, and DASH scores, regardless of operative or nonoperative treatment. Subjective satisfaction and functional scores were comparable between these groups. For those treated surgically, 5 patients (11.1%) sustained a surgical postoperative complication. CONCLUSION: In our case series, patients were able to achieve satisfactory outcomes regardless of whether they were treated nonoperatively or with an anatomic single-incision approach for complete or partial DBBT ruptures.

Radiographic alterations in clavicular bone tunnel width following anatomic coracoclavicular ligament reconstruction (ACCR) for chronic acromioclavicular joint injuries.

PURPOSE: To evaluate tunnel widening and its relationship in loss of reduction and clinical outcomes in patients undergoing anatomic coracoclavicular ligament reconstruction (ACCR) using free tendon grafts for chronic acromioclavicular (AC) joint injuries. METHODS: A retrospective chart review was performed on patients undergoing ACCR for type III-VI AC joint injuries between January 2003 and December 2017. For radiographic analysis, pre- and post-operative coracoclavicular distance (CCD) and tunnel width of the medial and lateral clavicular bone tunnel were measured at the earliest (EPO) and latest postoperative follow-up (LPO). To determine the clinical relevance of improvement in clinical outcome score (American Shoulder and Elbow Surgeons score) substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) thresholds were used. RESULTS: Twenty-four patients with a mean clinical follow-up of 37 ± 35 months (mean age 44.7 ± 13.4) were included in the study. Both the medial (5.6 ± 0.2 mmEPO-6.6 ± 0.7 mmLPO; p < 0.001) and lateral (5.6 ± 0.5 mmEPO-6.8 ± 1 mmLPO; p < 0.001) clavicular bone tunnel showed significant widening from EPO to LPO. There was a significant loss of reduction at LPO (CCDLPO 10.1 ± 4 mm) compared to EPO (CCDEPO: 6.2 ± 3.8 mm) (p < 0.001). No significant correlation between loss of reduction and medial (p = 0.45; r = - 0.06) or lateral (p = 0.69; r = - 0.06) tunnel widening was found. Alterations in tunnel width were shown having no influence on clinical outcomes. CONCLUSION: Patients who underwent ACCR using a free tendon graft for the treatment of chronic type III-VI ACJ injuries showed significant clavicular bone tunnel widening during the postoperative course. No correlation between tunnel widening and loss of reduction was shown with radiographic findings having no influence on clinical benefit and satisfaction. STUDY DESIGN: Case Series; Level of evidence, IV.