Two-year outcomes with a bioinductive collagen implant used in augmentation of arthroscopic repair of full-thickness rotator cuff tears: final results of a prospective multicenter study.

BACKGROUND: Full-thickness rotator cuff tears (FTRCTs) represent a common shoulder injury that, if untreated, can progress in size, become increasingly painful, and inhibit function. These lesions are often surgically repaired, with double-row arthroscopic repair often preferred for larger tears. Biological augmentation technologies have been developed to improve rates of postoperative radiographic retear and enhance patient-reported outcomes after surgical FTRCT repair. This study sought to confirm that augmented repair with a bioinductive bovine collagen implant results in favorable retear rates and patient outcomes with follow-up to 2 years. METHODS: A prospective multicenter cohort study was undertaken to determine the efficacy and safety of augmenting single- or double-row arthroscopic repair of FTRCTs with a bioinductive bovine collagen implant. Of 115 adult patients participating, 66 (57.4%) had medium (1-3-cm) tears and 49 (42.6%) had large (3-5-cm) tears. Magnetic resonance imaging and patient-reported outcomes (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form [ASES] and Constant-Murley Score [CMS]) were performed and recorded at baseline, 3 months, 1 year, and 2 years. RESULTS: Mean duration of follow-up was 2.1 years (range, 1.5-2.9 years). Between baseline and 2-year follow-up, mean total thickness of the supraspinatus tendon increased by 12.5% for medium tears and by 17.1% for large tears. Radiographic retear was noted in 7 of 61 available patients (11.5%) with medium tears, and in 14 of 40 patients (35.0%) with large tears. In both groups, these tears primarily occurred before the 3-month follow-up visit (13 of 21 [61.9%]). Radiographic retear with the supplemented double-row (DR) repair technique was 13.2% overall (12 of 91 DR patients; 11.3% for medium tears and 15.8% for large tears). The minimal clinically important difference was achieved by >90% of patients with both medium and large tears for both ASES and CMS. There were 2 serious adverse events classified by the treating surgeon as being possibly related to the device and/or procedure (1 case of swelling/drainage and 1 case of intermittent pain). Nine patients (7.8%; 4 medium tears and 5 large tears) required reoperation of the index rotator cuff surgery. CONCLUSION: Final 2-year data from this study confirm that using this implant in augmentation of arthroscopic double-row repair of FTRCTs provides favorable rates of radiographic retear and substantial functional recovery. The relative safety of the device is also further supported.

Arthroscopic Superior Capsular Reconstruction Using Hamstring Allograft.

Superior capsular reconstruction (SCR) has become an acceptable treatment option for patients with chronic shoulder pain in the setting of an irreparable rotator cuff tear. Several different techniques have been described with varying graft options. In this Technical Note, we introduce a technique for arthroscopic SCR using hamstring allograft tendon. Our described technique allows for a "one-size-fits-all" graft with a "build as you go" construct with no need for intraoperative dimensional defect measurements or specific graft modifications. This technique provides a reliable and reproducible procedure using readily available graft tissue.

Full-Thickness Rotator Cuff Tears Can Be Safely Treated With a Resorbable Bioinductive Bovine Collagen Implant: One-Year Results of a Prospective, Multicenter Registry.

PURPOSE: The purpose of this study was to prospectively collect safety and efficacy data in a large group of patients undergoing arthroscopic repair of full-thickness rotator cuff tears augmented with a resorbable bioinductive bovine collagen implant designed to promote healing. METHODS: Seventeen centers across the United States enrolled patients in an institutional review board-approved registry to collect outcomes data on the implant. Patients undergoing surgical management of full-thickness rotator cuff tears augmented with the implant were enrolled. Inclusion criteria were age of ≥21 years, willingness to participate and the ability to read and speak English. Exclusion criteria included hypersensitivity to bovine-derived products. Patients were assessed before and after surgery at up to 1 year with outcomes including the single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) mental components and physical components (VR-12 PCS), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcome measures. Ad hoc analyses were performed to compare these outcomes at all time points depending on tear size (small/medium vs large/massive). Serious complications were collected. RESULTS: Of 210 patients enrolled, 192 had 1-year follow-up data available. The patients experienced statistically significant improvement between baseline and 1 year for mean SANE, VR-12 PCS, ASES, and WORC scores (40.0-82.0, 33.5-47.3, 46.2-87.8, and 36.2-81.0, respectively; P < .001 for all results). Ad-hoc analysis demonstrated that similar results were obtained at 1 year regardless of tear size. Twenty patients (10.4%) experienced serious complications (10.4%), including revision surgery (n = 18), proximal humerus fracture/partial subscapularis tear resulting from multiple falls (n = 1), and adhesive capsulitis (n = 1). CONCLUSIONS: The safety and efficacy of a bioinductive implant in the surgical management of full-thickness rotator cuff tears at 1 year was shown in this study. Implant efficacy appears to be comparable regardless of the underlying tear size. LEVEL OF EVIDENCE: Level IV, therapeutic case series.

Treatment of Partial-Thickness Rotator Cuff Tears With a Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From a Prospective Multicenter Registry.

BACKGROUND: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in situ repair, and take-down and repair. A resorbable bioinductive bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. PURPOSE: Data from a registry were analyzed to further establish that the implant contributes to improved patient-reported outcome (PRO) scores across a large number of patients treated for partial-thickness rotator cuff tears. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A total of 19 centers in the United States enrolled patients >21 years old with partial-thickness tears of the rotator cuff in a comprehensive prospective multicenter registry. PRO scores were recorded preoperatively and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year: American Shoulder and Elbow Surgeons, Single Assessment Numeric Evaluation, Veterans RAND 12-Item Health Survey (physical and mental component scores), and Western Ontario Rotator Cuff scores. Revisions were reported throughout the study. RESULTS: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (IBR; collagen implant placed after bursectomy without a traditional rotator cuff repair), and 31 who had take-down and repair with bioinductive augmentation. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months. Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores as compared with those who underwent IBR, but the difference was no longer significant at 1 year for all but the physical component score of the Veterans RAND 12-Item Health Survey. There were 11 revisions, which occurred at a mean ± SD of 188.7 ± 88.0 days after the index surgery. There were no infections. CONCLUSION: This registry analysis further establishes across a large data set that this resorbable bioinductive bovine collagen implant improves PROs in all grades of partial-thickness tears, whether used as IBR or in conjunction with take-down and repair. IBR may offer improved early clinical outcomes (≤6 weeks) and comparable outcomes at 1 year when compared with a more invasive "take-down and repair" approach.

Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: a prospective multicenter study.

BACKGROUND: Biologic technologies can potentially augment existing arthroscopic rotator cuff repair to improve retear rates and postoperative outcomes. The purpose of this study was to evaluate healing rates and clinical outcomes of full-thickness rotator cuff repairs augmented with a bioinductive bovine collagen implant. METHODS: In this prospective multicenter study, investigators enrolled 115 patients (mean age, 60.4 years) with full-thickness rotator cuff tears. There were 66 (57.4%) medium (1-3 cm) tears and 49 (42.6%) large (3-5 cm) tears. Eligible patients consisted of those ≥21 years of age with chronic shoulder pain lasting longer than 3 months and unresponsive to conservative therapy. Patients underwent single- or double-row repair augmented with a bioinductive bovine collagen implant. At the baseline, 3 months, and 1 year, magnetic resonance imaging was performed and patients were assessed for American Shoulder and Elbow Surgeons (ASES) Shoulder Score and Constant-Murley Score (CMS). The primary failure end point was retear, classified as any new full-thickness defect observed on magnetic resonance imaging. RESULTS: There were 13 retears (11.3%) at 3 months, with an additional 6 (19 total [16.5%]) found at 1 year. In large tears, double-row repair had a significantly lower rate of retear at 3 months (P = .0004) and 1 year (P = .0001) compared with single-row repair. ASES and CMS scores significantly improved between the baseline and 1 year for medium and large tears. At 1 year, the minimally clinically important difference for ASES and CMS was met by 91.7% (95% CI: 84.9-96.1) and 86.4% (95% CI: 78.2-92.4) of patients, respectively. Patients without retear and those <65 years of age had significantly better CMS scores at 1 year when compared with those with retear and those ≥65 years (P < .05). There was no statistically significant difference in outcomes based on treatment of the biceps tendon. Of 9 reported reoperations in the operative shoulder, only 2 were considered potentially related to the collagen implant. CONCLUSION: Interim results from this prospective study indicate a favorable rate of retear relative to the literature and improvement in clinical function at 1 year after adjunctive treatment with the study implant augmenting standard arthroscopic repair techniques.

Arthroscopically Assisted Acromioclavicular Joint Reconstruction Using the Infinity-Lock Button System With Allograft Augmentation.

Acromioclavicular (AC) joint injuries are extremely common in the athletic population. Although most low-grade injuries can be managed nonoperatively, high-grade injuries often require reconstruction of the AC joint. Various reconstructive options have been described with varying risks and benefits to each. Implant or graft failure with loss of reduction as well as clavicle and coracoid fracture are a few of the more common complications following AC joint reconstruction surgery. Currently, no gold standard exists. This technical paper describes an arthroscopically assisted AC joint reconstruction technique using the Infinity-Lock Button System with hamstring allograft augmentation. This technique provides an anatomic, minimally invasive, low-profile reconstruction that may minimize risk of clavicle and coracoid fracture. It also provides augmented stabilization across the AC joint, which may also help resist naturally occurring horizontal and rotational displacing forces.

Arthroscopically Assisted Acute Acromioclavicular Joint Reconstruction Using the Infinity-Lock Button System.

Acromioclavicular (AC) joint injuries are the most common shoulder injuries in the athletic population. The literature is rife with various surgical techniques and implants as well as opinion on proper timing of surgical options. Patient outcomes are generally similar across fixation method. Complications are common following reconstruction, and the specific type of complication may depend on the technique used. Fracture and graft elongation are associated with use of allograft, whereas button cutout and skin irritation can occur with cortical suture-fixation methods. This technical paper describes an arthroscopically assisted acute AC joint reconstruction technique using the Infinity-Lock Button System. This technique provides a minimally invasive, low-profile reconstruction that may minimize risk of clavicle and coracoid fracture as well as overlying skin irritation. Acute reconstruction may permit healing of the native coracoclavicular and AC ligaments and mitigate risk of future AC joint arthritis.

Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears.

PURPOSE: To collect outcomes data on patients treated with a bioinductive collagen implant designed to induce rotator cuff healing in partial- and full-thickness cuff tears and to assess the safety and efficacy of the device. METHODS: Fifteen surgeons in 15 centers in the United States enrolled patients between April 2016 and August 2017 and collected standardized outcomes data. Patients 21 years of age and older, able to read and speak English, and with partial- or full-thickness tears of the rotator cuff documented by magnetic resonance imaging were included in the study. Patients were assessed preoperatively with visual analogue scale (VAS), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcomes measures. Postoperative assessment was made at 2, 6, and 12 weeks, 6 months, and 1 year. Patients underwent a standardized operative procedure with the implant. Patient demographics, comorbidities, tear types, and concomitant operative procedures were recorded. RESULTS: Patients in both groups experienced statistically significant improvement in VAS, SANE, VR-12 PCS, ASES, and WORC scores (mean values 1.1, P < .001; 86.0, P < .001; 49.7, P < .001; 85.6, P < .001; and 84.4, P < .001 for partial tears and 1.2, P < .001; 80.7, P < .001; 45.7, P < .001; 83.8, P < .0001; and 80.1, P < .001 for full-thickness tears, respectively). For the partial tear group, average times for return to driving, work, and nonoverhead athletic activity were 14.6, 37.3, and 65.6 days, and for the full-thickness group, 24.5, 50.7, and 119.2 days, respectively. In the partial-thickness group, 84% and 83% of patients reported improvement in their VAS pain and ASES scores, respectively, that met or exceeded each measure's minimal clinically important difference. In the full-thickness group, 72% and 77% of the patients met or exceeded the minimal clinically important differences for VAS pain and ASES, respectively. CONCLUSION: Outcomes after repair of partial- and full-thickness rotator cuff tears using a bioinductive implant show safety and efficacy at 1-year follow-up. LEVEL OF EVIDENCE: Retrospective case series, level IV evidence.

Lesser Tuberosity Avulsion Fracture Repair Using Knotless Arthroscopic Fixation.

Although some literature may suggest that acute nondisplaced lesser tuberosity fractures should undergo nonoperative management, there is a body of evidence that supports surgical stabilization of these injuries due to concern for fracture displacement, nonunion and malunion, anteromedial impingement, and possible biceps tendon subluxation or dislocation. In this Technical Note, we introduce a novel technique for arthroscopic fixation of lesser tuberosity avulsion fractures using a knotless repair. In the lateral decubitus position using standard arthroscopic portals, with the addition of the biceps accessory portal, 2 ULTRATAPE sutures are fixed to the avulsed fragment in luggage-tag fashion to create a secure, knotless fixation. These are used to mobilize and anatomically approximate the lesser tuberosity to the avulsion bed and are held in place with suture anchors placed immediately adjacent to the fracture bed. This technique provides good anatomic reduction with maximal surface area for bone-to-bone healing.

Arthroscopic Triple Labral Repair in an Adolescent.

Traumatic glenohumeral dislocations often result in significant injury to the anterior-inferior labrum, most commonly leading to recurrent anterior instability. While in skeletally immature patients, shoulder trauma more commonly results in fracture versus a true dislocation, shoulder instability does occur and can be difficult to manage in the setting of open physes. In any event, the goal of treatment is to reduce the risk of recurrence and allow full participation in activities, including sports. Arthroscopic stabilization has been shown to be an effective treatment option for young patients, with good return to sport rates; however, the vast majority of literature on shoulder instability in the youth patient population focuses on anterior instability. Concomitant lesions of the anterior, posterior, and superior labrum have been rarely described in youth athletes and present a formidable clinical challenge, particularly in skeletally immature patients. In this Technical Note, we describe the authors' preferred technique for arthroscopic repair of a traumatic triple labral tear, including anterior, posterior, and type IV SLAP components, in adolescent patients.

The "Floating Labrum": Bankart Lesion Repair With Anterior Capsular Extension Using 2 Anterior Working Portals.

Surgical repair of a Bankart lesion requires thorough recognition of the capsulolabral attachment and adequate visualization for suture anchor repair. The glenoid labrum usually detaches from its capsule and bony attachment anteriorly and inferiorly; however, the labral and capsule detachment can sometimes extend beyond this zone of injury. Identification and repair may require additional viewing and working portals to allow for ease of suture passage and anchor placement. This technique guide describes a case scenario of a Bankart lesion with anterior extension of the capsular tear, repaired with use of 2 anterior working portals.

Surgical Exposures of the Shoulder.

Surgical repair, reduction, fixation, and reconstruction for glenohumeral trauma, instability, and degenerative joint disease often require an open surgical exposure. Open shoulder surgery is challenging because the deltoid and rotator cuff musculature envelop the joint, and in most approaches, exposure is limited by the proximity and importance of the axillary nerve. An understanding of the importance of the deltoid and the rotator cuff for glenohumeral function has led to a progression of innovative, advanced, and less invasive approaches to the shoulder. Various advantages, disadvantages, and risks are encountered when performing deltopectoral, deltoid-splitting, and posterior approaches to the glenohumeral joint, with variations of each approach and techniques to extend them and maximize exposure. The ability to perform each of these exposures provides the surgeon with the flexibility to best address the widest variety of pathology.

Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device With Allograft Augmentation: Surgical Technique.

Surgical management of acromioclavicular (AC) joint separations remains challenging, especially in the revision setting. Most commonly, Rockwood type I and II injuries are managed nonoperatively whereas type IV, V, and VI injuries are managed with surgery. Type III separations are more controversial, with evidence supporting both nonoperative and operative treatment options. Multiple different arthroscopic techniques have been described; however, there is no current gold standard. AC joint reconstruction with the TightRope device (Arthrex, Naples, FL) with the patient in the lateral decubitus position is a method of restoring joint stability that allows for a minimally invasive, low-profile fixation construct using a single drill hole through the clavicle. Allograft augmentation of this fixation construct helps to eliminate the stress risers potentially created by this device while increasing overall repair construct stability. The purpose of this article is to describe the surgical technique for arthroscopic AC joint reconstruction using a TightRope device with allograft augmentation.

All-arthroscopic patch augmentation of a massive rotator cuff tear: surgical technique.

Surgical management of massive rotator cuff tears remains challenging, with failure rates ranging from 20% to 90%. Multiple different arthroscopic and open techniques have been described, but there is no current gold standard. Failure after rotator cuff repair is typically multifactorial; however, failure of tendon-footprint healing is often implicated. Patch augmentation has been described as a possible technique to augment the biology of rotator cuff repair in situations of compromised tendon quality and has shown promising short-term results. The purpose of this article is to describe our preferred surgical technique for arthroscopic rotator cuff repair with patch augmentation.

Primary repair of ulnar collateral ligament injuries of the elbow in young athletes: a case series of injuries to the proximal and distal ends of the ligament.

BACKGROUND: Little data exist regarding the treatment of young high school and college athletes with medial ulnar collateral ligament insufficiency of the elbow. It would be logical to assume that younger patients would have less damage to the ligament, allowing the possibility of repair. HYPOTHESIS: Many young athletes with injuries to the medial ulnar collateral ligament have proximal or distal injuries that may be amenable to repair, indicating that graft reconstruction may not always be necessary to obtain satisfactory results. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Sixty patients who had direct repair of the medial ulnar collateral ligament were retrospectively evaluated using the Andrews and Carson elbow score. All patients had symptomatic instability that precluded them from participation in their desired sports, all failed a nonoperative treatment program, and all had comparative stress radiographs, magnetic resonance images, or computerized tomograms with contrast studies that had positive findings for insufficiency of the ligament. RESULTS: The mean age of the 47 male and 13 female patients was 17.2 years. The mean follow-up was 59.2 months. All patients underwent medial ulnar collateral ligament repair by one of the following procedures: suture plication with repair to bone drill holes (n = 9) or suture repair to bone using anchors (n = 51). The mean overall preoperative Andrews-Carson outcome score of 132 improved to 188 postoperatively (P < .0001). Good-to-excellent overall results were obtained in 93% of patients. Fifty-eight of the 60 patients were able to return to sports within 6 months of the surgery at the same or higher level as before the injury. There were 4 failures, 2 early and 2 late (after return to play for 5 and 6 years of unrestricted play, respectively). Three patients sustained a complication of transient postoperative ulnar neuropathy symptoms that resolved spontaneously. CONCLUSION: Primary repair of proximal and distal injuries of the medial ulnar collateral ligament is a viable alternative in the non-professional athlete. Graft reconstructions may not be necessary to obtain favorable outcomes and rapid return to sports in non-professional athletes who require surgical intervention for medial elbow instability.

Operative treatment of ulnar collateral ligament insufficiency of the elbow in female athletes.

BACKGROUND: As women become more involved in athletic activity, injuries specific to this population also increase. No data exist regarding operative treatment of female patients with elbow instability secondary to ulnar collateral ligament insufficiency. HYPOTHESIS: Women with symptomatically unstable elbows who failed nonoperative treatment will improve after surgical intervention. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Nineteen women were retrospectively evaluated using the Andrews and Carson Elbow Outcome Score. Patients were included if they underwent repair or reconstruction of the ulnar collateral ligament for symptomatic instability that precluded them from participation in their desired sport or activities, despite nonoperative treatment. RESULTS: The mean age was 22.0 years (range, 15.1-37.2 years). The mean follow-up was 38.8 months (range, 12.4-68.6 months). Of the 19 patients, 14 were softball players, gymnasts, and tennis players. Only 1 was a pitcher. Eighteen women underwent repair by one of the following procedures: plication (n = 6), repair to bone using anchors (n = 11), or drill holes (n = 1). One patient underwent a palmaris graft reconstruction. The mean overall preoperative outcome score of 120 improved to 191 postoperatively (P < .0001). Seventeen of 18 athletes were able to return to their sport at a mean of 2.5 months postoperatively. One patient did not participate in athletics. CONCLUSION: This study demonstrated excellent overall results in 16 and good results in 3 female patients after medial elbow repair or reconstruction. Women appear to be able to consistently return to a high level of function after repair or reconstruction for medial elbow instability.