scholarly journals Subacromial Balloon Spacer versus Partial Repair for Massive Rotator Cuff Tears: A Prospective, Randomized, Multi-center Trial

2021 ◽  
Vol 9 (7_suppl4) ◽  
pp. 2325967121S0024
Author(s):  
Umasuthan Srikumaran ◽  
Colleen Roden ◽  
EDWIN ROGUSKY ◽  
Peter Lapner ◽  
Joseph Abboud ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Clinical Outcome ◽  
Rotator Cuff Tears ◽  
Partial Repair ◽  
Massive Rotator Cuff Tears ◽  
Spacer Group ◽  
N 93 ◽  
Cuff Repair ◽  
Repair Group

Objectives: Despite various treatment options, the successful management of irreparable, massive rotator cuff tears (MRCTs) remains challenging. Implantation of a biodegradable subacromial balloon spacer (InSpaceTM system; OrthoSpace, Caesarea, Isreal) has gained considerable interest for the treatment of MCRTs due to its ability to effectively recenter the humeral head within the glenoid. Despite promising results, investigations examining outcomes following balloon spacer implantation are limited to small case series and short-term prospective trials without comparison to other surgical modalities. The purpose of the present investigation was to prospectively evaluate the safety and efficacy of the arthroscopically deployed, subacromial spacer balloon compared to partial rotator cuff repair in patients with MRCTs at 24 month follow up. Methods: A non-inferiority, prospective, single-blinded, multicenter, randomized, controlled, pivotal study was conducted to compare the outcomes of arthroscopic subacromial balloon spacer implantation to partial repair in the treatment of MRCTs. Patients ≥ 40 years of age with symptomatic full thickness MRCTs (tears ≥ 5 cm or ≥ 2 tendons) that had failed non-operative management were included. Clinical outcome data, derived from subjective questionnaires and physical examination, were collected at baseline and follow-up intervals at Day 10, Week 6, Month 3, 6, 12 and 24. Postoperative magnetic resonance imaging (MRI) scans were obtained at 6 weeks and 12 months. The primary composite effectiveness endpoint was defined as achievement of the minimal clinically important difference (MCID) for the Western Ontario Rotator Cuff (WORC) score (275 points) and American Shoulder and Elbow Society (ASES) score (6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). Secondary effectiveness endpoints included changes in individual and composite clinical outcome scores relative to baseline in addition to MRI findings. Intention-to-treat (ITT), per-protocol (PP), and safety analyses were performed separately. Results: A total of 20 sites were enrolled in the investigation. One hundred, eighty-four patients were randomized into the clinical study (n= 93 balloon spacer; n= 91 partial repair) and included in the safety population, of which 183 patients were included in the ITT analysis (n=93 balloon spacer; n= 90 partial repair) and 176 in the PP analysis (n= 88 balloon spacer; n= 88 partial repair). No significant difference in demographic characteristics based on mean age, sex, race or body mass index were appreciated between groups. Mean procedure duration was 44.6 ± 16.9 minutes for the balloon spacer group and 71.2 ± 30.1 minutes for the partial repair group. Significant improvement over time relative to baseline was observed in all WORC (Fig. 1) and ASES (Fig. 2) scores in both groups. The magnitude of improvement for subjects in the balloon spacer group was the same or better than for subjects in the partial repair group at 12 and 24 month follow up. At 12 months, 51% (n=45 of 88) of patients in the balloon spacer group and 35 patients 40% (n= 35 of 88) in the partial repair group had reached and maintained the primary composite endpoint, meeting the noninferiority criteria (non-inferiority margin 10%; p = 0.0049) and corresponding to an 11.4% mean advantage for the spacer implant group. Non-inferiority was similarly confirmed in the ITT population (p=0.0089). SSSI occurred in 6 subjects (n=3 balloon spacer; n=3 partial repair), with two subjects in each group requiring reverse shoulder arthroplasty and one subject in each group undergoing shoulder arthroscopy. Conclusions: Use of the balloon spacer was found to produce non-inferior outcomes when compared to partial rotator cuff repair for patients with MRCTs at 24 month follow up. Outcomes following balloon spacer device placement met non-inferiority criteria when compared to the partial repair group based on primary composite endpoints.

scholarly journals Outcome of partial repair of massive rotator cuff tears with and without human tissue allograft bridging repair

2016 ◽  
Vol 9 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Radhakant Pandey ◽  
Suhayl Tafazal ◽  
Srinivasan Shyamsundar ◽  
Amit Modi ◽  
Harvinder Pal Singh
Keyword(s):  
Rotator Cuff ◽  
Human Tissue ◽  
Constant Score ◽  
Rotator Cuff Tears ◽  
Partial Repair ◽  
Massive Rotator Cuff Tears ◽  
Tissue Allograft ◽  
Tissue Matrix ◽  
Repair Group

Background The surgical management of massive rotator cuff tears remains a challenge. It is suggested that, even in a massive tear that appears irreparable, attempting to repair it as much as possible can be helpful in improving functional outcomes. However the results can be short term and variable. The purpose of our study was to determine if human tissue allograft bridged repair of massive irreparable rotator cuff tears to achieve a complete repair produces similar outcomes compared to partial repair alone. Methods We prospectively reviewed outcome scores in 13 patients who underwent partial repair alone for massive irreparable rotator cuff tears and compared them to 13 patients who had partial repairs bridged with allograft. Oxford and Constant scores were compared pre-operatively and at a minimum follow-up of 2 years (range 2 years to 5 years). Results The mean improvement in the Constant score at final follow-up compared to pre-operative scores was 27.7 points in the partial repair group and 42.8 points in the allograft group ( p < 0.01). The Oxford Shoulder Score improved mean of 19.3 points in the partial repair group and 29 points in the allograft group ( p < 0.02) at 2 years. Conclusions Human tissue matrix allograft provides a better outcome for open bridging of irreparable rotator cuff tears than partial repair alone.

Irreparable Large to Massive Rotator Cuff Tears With Low-Grade Fatty Degeneration of the Infraspinatus Tendon: Minimum 7-Year Follow-up of Fascia Autograft Patch Procedure and Partial Repair

2021 ◽  
pp. 036354652110435
Author(s):  
Daisuke Mori ◽  
Kazuha Kizaki ◽  
Noboru Funakoshi ◽  
Fumiharu Yamashita ◽  
Yasuyuki Mizuno ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Rotator Cuff ◽  
Clinical Outcomes ◽  
Fatty Degeneration ◽  
Rotator Cuff Tears ◽  
Low Grade ◽  
Partial Repair ◽  
Massive Rotator Cuff Tears ◽  
Infraspinatus Tendon

Background: In shoulders with irreparable massive rotator cuff tears (RCTs) with high-grade fatty degeneration (Goutallier stage 3 or 4) of the supraspinatus tendon and low-grade fatty degeneration (Goutallier stage 1 or 2) of the infraspinatus tendon (ISP), arthroscopic patch grafting (PG) has been reported as superior to partial repair (PR) regarding the ISP retear rate at short-term to midterm follow-up. However, the longer term outcomes are unclear. Purpose: To compare clinical and structural outcomes in the PG and PR groups at a minimum of 7 years postoperatively. Study Design: Cohort study; Level of evidence, 3. Methods: We evaluated 24 patients in the PG group and 24 patients in the PR group. We primarily used the Constant score for clinical outcomes and performed magnetic resonance imaging for structural outcomes in the PG and PR groups. The risk factors for a retear of the ISP were identified by univariate and multivariate (forward stepwise selection method) logistic regression analyses. We primarily compared values at midterm follow-up (<4 years) with values at the final follow-up (minimum 7 years) for each patient. Results: The mean midterm and final follow-up times for the PG group were 41.0 and 95.1 months, respectively, compared with 35.7 and 99.3 months, respectively, for the PR group. We found significant differences for the midterm and final follow-up Constant total scores in the PG and PR groups (midterm follow-up: 79.1 vs 69.9, respectively [ P = .001]; final follow-up: 76.0 vs 65.3, respectively [ P = .006]) and in the Constant strength scores (midterm follow-up: 14.6 vs 8.5, respectively [ P < .001]; final follow-up: 13.1 vs 8.3, respectively [ P = .001]). Treatment group (PR) was a significant predictor of an ISP retear in the logistic regression analysis (odds ratio, 3.545; P = .043). Conclusion: Patients with low-grade massive RCTs treated with PG or PR improved significantly in terms of clinical outcomes at the midterm and final follow-up time points. However, Constant scores were significantly better in the PG group at the final follow-up.

Equivalent Clinical Results of Arthroscopic Single-Row and Double-Row Suture Anchor Repair for Rotator Cuff Tears

2007 ◽  
Vol 35 (8) ◽  
pp. 1254-1260 ◽  
Author(s):  
Francesco Franceschi ◽  
Laura Ruzzini ◽  
Umile Giuseppe Longo ◽  
Francesca Maria Martina ◽  
Bruno Beomonte Zobel ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Suture Anchor ◽  
Rotator Cuff Tears ◽  
Double Row ◽  
Single Row ◽  
Group 2 ◽  
Cuff Repair ◽  
Repair Group ◽  
Group 1

Background Restoring the anatomical footprint may improve the healing and mechanical strength of repaired tendons. A double row of suture anchors increases the tendon-bone contact area, reconstituting a more anatomical configuration of the rotator cuff footprint. Hypothesis There is no difference in clinical and imaging outcome between single-row and double-row suture anchor technique repairs of rotator cuff tears. Study Design Randomized controlled trial; Level of evidence, 1. Methods The authors recruited 60 patients. In 30 patients, rotator cuff repair was performed with a single-row suture anchor technique (group 1). In the other 30 patients, rotator cuff repair was performed with a double-row suture anchor technique (group 2). Results Eight patients (4 in the single-row anchor repair group and 4 in the double-row anchor repair group) did not return at the final follow-up. At the 2-year follow-up, no statistically significant differences were seen with respect to the University of California, Los Angeles score and range of motion values. At 2-year follow-up, postoperative magnetic resonance arthrography in group 1 showed intact tendons in 14 patients, partial-thickness defects in 10 patients, and full-thickness defects in 2 patients. In group 2, magnetic resonance arthrography showed an intact rotator cuff in 18 patients, partial-thickness defects in 7 patients, and full-thickness defects in 1 patient. Conclusion Single- and double-row techniques provide comparable clinical outcome at 2 years. A double-row technique produces a mechanically superior construct compared with the single-row method in restoring the anatomical footprint of the rotator cuff, but these mechanical advantages do not translate into superior clinical performance.

scholarly journals Partial Rotator Cuff Repair With Superior Capsular Reconstruction Using the Biceps Tendon Is as Effective as Superior Capsular Reconstruction Using a Tensor Fasciae Latae Autograft in the Treatment of Irreparable Massive Rotator Cuff Tears

2020 ◽  
Vol 8 (6) ◽  
pp. 232596712092252 ◽  
Author(s):  
Baris Kocaoglu ◽  
Goktug Firatli ◽  
Tekin Kerem Ulku
Keyword(s):  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
Biceps Tendon ◽  
Rotator Cuff Tears ◽  
Massive Rotator Cuff Tears ◽  
Superior Capsular Reconstruction ◽  
Functional Scores ◽  
Tensor Fasciae Latae ◽  
Cuff Repair

Background: Several treatment options are available for stable massive rotator cuff tears, including partial repair with or without tissue augmentation, tendon transfer, superior capsular reconstruction (SCR), and reverse shoulder arthroplasty. Purpose/Hypothesis: The purpose of this study was to compare the outcomes and effectiveness of partial rotator cuff repair with SCR using the long head of the biceps tendon (PRCR-SCRB) and SCR with a tensor fasciae latae autograft (SCRTF) for the treatment of rotator cuff tears with severe fatty degeneration. The hypothesis of this study was that SCRTF would be superior to PRCR-SCRB in functional and anatomic outcomes. Study Design: Cohort study; Level of evidence, 3. Methods: A total of 26 consecutive patients with massive and fatty degenerative rotator cuff tears were treated surgically. Patients were divided into either the PRCR-SCRB group (n = 14) or SCRTF group (n = 12). Functional outcomes were assessed at final follow-up, and the acromiohumeral distance (AHD) was measured. Results: All functional scores significantly improved in both groups at final follow-up. The PRCR-SCRB group showed better overall outcomes in terms of the visual analog scale for pain; American Shoulder and Elbow Surgeons score; and Quick Disabilities of the Arm, Shoulder and Hand, but these differences were not statistically significant. Better outcomes were found for only the AHD for the PRCR-SCRB group without statistical significance ( P = .4). No statistical difference was found in terms of retear rate. Conclusion: PRCR-SCRB had comparable outcomes and improvement in AHD compared with SCRTF without the need for additional graft harvesting.

scholarly journals Midterm Functional and Structural Outcomes of Large/Massive Cuff Tears Treated by Arthroscopic Partial Repair

2021 ◽  
Vol 9 (3) ◽  
pp. 232596712098879
Author(s):  
Hiroaki Moriyama ◽  
Masafumi Gotoh ◽  
Koji Tanaka ◽  
Yashuhiro Mitsui ◽  
Hidehiro Nakamura ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Functional Outcome ◽  
Clinical Outcomes ◽  
Outcome Measures ◽  
Japanese Orthopaedic Association ◽  
Rotator Cuff Tears ◽  
Partial Repair ◽  
Massive Rotator Cuff Tears ◽  
Tear Size

Background: Previous studies have shown good clinical outcomes in patients with irreparable large or massive rotator cuff tears treated using arthroscopic partial repair (APR); however, few studies have evaluated both functional and structural outcomes in these patients. Purpose: To evaluate both functional and structural outcomes in patients with large or massive rotator cuff tears treated using APR. Study Design: Case series; Level of evidence, 4. Methods: Between March 2009 and November 2016, a total of 30 patients underwent APR because of the irreparability of their large or massive rotator cuff tears during surgery. Of these patients, 24 completed the minimum 24-month follow-up (mean, 61.8 ± 27.1 months; range, 24-112 months) and were included in this study. Functional outcome measures included the Japanese Orthopaedic Association (JOA) and University of California Los Angeles (UCLA) scores and the visual analog scale for pain. Structural outcome measures comprised preoperative fatty degeneration, mediolateral tear size, residual tendon attachment area, and glenohumeral (GH) arthritic changes evaluated on magnetic resonance imaging scans or plain radiographs before and after surgery. Functional and structural outcomes were evaluated preoperatively, at 3 months postoperatively, and at the final follow-up. Results: The JOA scores for all patients significantly improved from 67.9 ± 11.3 preoperatively to 85.4 ± 15.6 postoperatively ( P < .0001). Similarly, the UCLA scores significantly improved from 15.8 ± 4.20 preoperatively to 29 ± 6.69 at final follow-up postoperatively ( P < .0001). The mediolateral tear size were significantly decreased at 3 months postoperatively ( P < .001) and at the final follow-up ( P < .001). Compared with preoperative scores, the novel score evaluating the residual tendon attachment area improved from 3.08 ± 0.46 to 3.54 ± 0.41 ( P < .001) after surgery overall, although it significantly deteriorated from 3 months postoperatively to the final follow-up. GH osteoarthritis progressed in 6 patients (25%). Patients who developed osteoarthritis had lower JOA and UCLA scores than did those who did not (JOA, P = .010; UCLA, P = .037). Conclusion: In irreparable large or massive rotator cuff tears treated using APR, functional outcome improved after surgery. Although the residual tendon attachment area improved, functional outcome after APR corresponded to the GH alterations at the midterm follow-up. Longer-term follow-up is needed to further elucidate the effect of APR on clinical outcomes in these patients.

scholarly journals Tendon Repair Leads to better Long-Term Clinical Outcome than Debridement in Massive Rotator Cuff Tears

2017 ◽  
Vol 11 (1) ◽  
pp. 546-553 ◽  
Author(s):  
Matthias Alexander König ◽  
Volker Alexander Braunstein
Keyword(s):  
Rotator Cuff ◽  
Clinical Outcome ◽  
Tendon Repair ◽  
Shoulder Function ◽  
Rotator Cuff Tears ◽  
Short Term ◽  
Massive Rotator Cuff Tears ◽  
Massive Tears

Introduction: Massive tears in the rotator cuff are debilitating pathologies normally associated with loss of function and pain. Tendon reconstruction is seen as the standard treatment in order to preserve shoulder function and to inhibit cuff associated osteoarthritis. However, the effect on longer-term shoulder function and patient satisfaction is unknown. Material and Methods: 165 consecutive patients with massive tears were included. 57 debridement (mean age 61.9±8.7 years (range 43-77)) and 108 reconstruction (mean age 57.5±8.9 years (range 45-74)) cases could be followed up 2-4 (short-term), 5-6 (mid-term) and 8-10 (long-term) years after surgery. Evaluation was performed with the Constant, a modified ASES and the DASH score. Statistical analysis was done using Sigma-Stat Version 3.5 with a p-value<0.05 indicating statistical significant differences. Results: All three scoring systems showed no significant differences in the short-term follow-up for the two groups (mean values: Constant debridement/repair: 70±11.9/66±13.6; ASES debridement/repair: 22.3±3.3/ 23.3±3.3; DASH debridement/repair: 22.3±11.0/ 24.3±10.1). In the mid-term (Constant debridement/repair: 51±2.9/68.3±5.2; ASES debridement/repair: 20.3±1.3/24.3±1.7; DASH debridement/repair: 31.0±6.5/20.3±5.4) and long-term follow-up (Constant debridement/repair: 42.3±3.8 /60.7±2.6, ASES debridement/repair: 17.3±0.5/21.7±0.5, DASH debridement/repair: 41.3±6.2/25.0±1.4), rotator cuff reconstruction revealed better objective results and better patients’ satisfaction. Conclusion: Rotator cuff tendon repair leads to better long-term clinical outcome and subjective satisfaction compared to debridement. Tendon reconstruction should be considered as a treatment for patients suffering from massive rotator cuff tears, thus preserving shoulder function and by that means delay indication for reverse arthroplasty.

scholarly journals Arthroscopic Rotator Cuff Repair With Muscle Advancement and Artificial Biodegradable Sheet Reinforcement for Massive Rotator Cuff Tears

2020 ◽  
Vol 8 (10) ◽  
pp. 232596712096016
Author(s):  
Shin Yokoya ◽  
Yohei Harada ◽  
Hiroshi Negi ◽  
Ryosuke Matsushita ◽  
Norimasa Matsubara ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Failure Rate ◽  
Rotator Cuff Tears ◽  
Control Group ◽  
Study Group ◽  
Massive Rotator Cuff Tears ◽  
Arthroscopic Rotator Cuff ◽  
Cuff Repair ◽  
Isometric Muscle

Background: Because high failure rates have frequently been reported after arthroscopic rotator cuff repair (ARCR) of massive rotator cuff tears (mRCTs), we introduced the technique of ARCR with supraspinatus and infraspinatus muscle advancement (MA). However, for cases where the original footprint cannot be completely covered, additional surgery using an approved artificial biomaterial is performed. Purpose: To investigate the postoperative clinical outcomes and failure rate after MA-ARCR, with and without our reinforcement technique. Study Design: Cohort study; Level of evidence, 3. Methods: A total of 74 patients (mean ± SD age, 68.7 ± 7.7 years) diagnosed with mRCT with a minimum postoperative follow-up of 2 years were included in the current study. Of these patients, 47 underwent MA-ARCR with polyglycolic acid (PGA) sheet reinforcement (study group), and 27 patients underwent MA-ARCR alone (control group). PGA reinforcement was performed when full coverage of the footprint could not be achieved by MA alone, but where the latter was possible, reinforcement was not required. Thus, the study group had significantly worse muscle quality than the control group ( P < .05). The pre- and postoperative range of motion (ROM), isometric muscle strength, acromiohumeral interval, and clinical outcomes were evaluated and compared between these 2 groups. Cuff integrity during the last follow-up period was assessed with magnetic resonance imaging, and the failure rate was calculated. In addition, the postoperative foreign body reaction was investigated in the study group. Results: In both groups, significant postoperative improvements were seen in acromiohumeral interval, clinical scores, ROM in anterior flexion, and isometric muscle strength in abduction, external rotation, and internal rotation ( P < .001 for all). The failure rate of the study group was 12.8% (6 patients) and that of the control group was 25.9% (7 patients). No significant differences were noted between the 2 groups on any of the data findings, even regarding the failure rate. Foreign body reactions in the early period were found in 3 patients, although these spontaneously disappeared within 3 months. Conclusion: Patients who underwent PGA patch reinforcement for MA-ARCR when the footprint could not be completely covered had clinical results similar to isolated MA-ARCR when the footprint could be covered. Both procedures resulted in significant improvement in symptoms and function compared with preoperatively.

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