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New solution for massive, irreparable rotator cuff tears: the subacromial "biodegradable spacer".

ABSTRACT: Massive, irreparable rotator cuff tears are a source of pain and disability. Although most rotator cuff tears can be completely repaired, a significant number are considered massive and irreparable. Numerous operative techniques have been described for the treatment of these kinds of tears including arthroscopic debridement, biceps tenotomy, tendon transfer, grafting, and reverse arthroplasty. We describe a surgical technique using a biodegradable subacromial balloon spacer (InSpace; OrthoSpace, Kfar Saba, Israel) implanted between the humeral head and acromion that permits smooth, frictionless gliding, restoring the shoulder biomechanics. The technique is easy to perform and is less invasive than the conventional surgical techniques available, and it may potentially serve as a bridging option in patients with massive, irreparable tears who are normally candidates for reverse arthroplasty.

SUBMITTER: Savarese E

PROVIDER: S-EPMC3678622 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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New solution for massive, irreparable rotator cuff tears: the subacromial "biodegradable spacer".

Savarese Eugenio E Romeo Rocco R

Arthroscopy techniques 20120504 1

Massive, irreparable rotator cuff tears are a source of pain and disability. Although most rotator cuff tears can be completely repaired, a significant number are considered massive and irreparable. Numerous operative techniques have been described for the treatment of these kinds of tears including arthroscopic debridement, biceps tenotomy, tendon transfer, grafting, and reverse arthroplasty. We describe a surgical technique using a biodegradable subacromial balloon spacer (InSpace; OrthoSpace, ...[more]

PMID: 23766979

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Project description:AimThe objective of this prospective non-randomized study was to establish the role of biodegradable sub-acromial spacer (InSpace™) insertion in the management of patients with massive irreparable rotator cuff tear by reporting beneficial effects on the pain relief and functional outcomes in these patients.MethodsThis is a prospective non-randomized study of patients treated for irreparable cuff tears during a period between January 2014 and November 2016.14 patients with symptomatic massive irreparable rotator cuff tears were managed with arthroscopic debridement and implantation of a biodegradable subacromial spacer and were followed up for at least one year (8-16 m). Inclusion criteria were patients with irreparable rotator cuff tears that failed the conservative management, with muscle retraction (Patte > stage 2), muscle atrophy, and fatty infiltration (Goutalier type 3). Patients with osteoarthritis grade 3 in the Hamada classification and/or without preserved passive motion were excluded from our study. Outcome measures included pre and postoperative, the range of motion, Constant and Oxford shoulder scores. The decision to perform surgery was made after failure of nonoperative treatment and rehabilitation (massive rotator cuff tear protocol, reading shoulder unit)for at least six months.ResultsFourteen shoulders (14 patients, ten male four female) met the inclusion criteria. The mean age of patients was 76.2 (70-85) years. During the last follow-up (8-16 months mean 12.6 months), the range of motion was significantly increased in all patients with anterior elevation (from 80 to 105°), abduction (from 70 to 110°), and external rotation (from 25 to 35°). The mean Constant score was also significantly (P < 0.001) improved from 22.5 (13-33) preoperatively to 51.4 (30-64) at the last follow-up. The Oxford shoulder score improved from 26 preoperatively (21-28) to 48.2 postoperatively (34-56). No night pain following surgery and ADL increased by 40%, which is significant in these patients. No significant perioperative complications were found except for one patient who had a spacer migration. However, no action was required in that case.ConclusionsArthroscopic implantation of a subacromial spacer for irreparable rotator cuff tear resulted in a noticeable improvement in pain relief and shoulder function at a mean 12.6 months follow up. It is a quick, safe and a minimally invasive procedure that is suitable for elderly patients with irreparable cuff tears and medical co-morbidities.

Project description:PurposeTo compare the clinical and radiographic outcomes of partial rotator cuff repair (RCR) with and without implantation of a biodegradable subacromial spacer in the treatment of symptomatic irreparable massive rotator cuff tears (MRCTs).MethodsPatients with MRCT who underwent arthroscopic partial repair alone (PR) or combined with subacromial spacer augmentation (PRS) were included. Patient-reported outcomes, including visual analog scale (VAS), American Shoulder and Elbow Surgeons (ASES), and Constant scores in addition to range of motion (ROM) were collected preoperatively and at the final follow-up. Additionally, we determined the percentages of all of the patients in groups that achieved the minimal clinical important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptomatic state (PASS) for the VAS, ASES, and Constant scores. Acromiohumeral distance (AHD) was determined as well.ResultsA total of 32 patients were included. Group PR included 20 patients with a median age of 68 years (range: 64-73) and median follow-up 28.0 months (14.0-60.0). Group PRS included 12 patients with a median age of 68.5 years (range: 63-74) and median follow-up of 17.0 months (12.0-32.0). At the final follow-up, the ASES, VAS, and Constant scores were significantly higher in the PRS group (75.5 [55-88.3], 1.0 [0-3], and 70.0 [43-79], respectively, compared to the PR group (55.0 [37.5-65], 2.0 [0-4], and 55.0 [31-79], respectively; P < .05). The only statistically significant differences were found between the PR and PRS groups in terms of the proportions of the patients who achieved MCID for the ASES (70% vs. 100%; P = .04) and in terms of the proportions of the patients who achieved SCB for the ASES (60% vs 100%; P = .01) There was also statistically significant difference between the PR and PRS groups, in terms of the proportions of the patients who achieved PASS for the VAS and ASES ([30 % vs 66.7 %; P = .04] and [0 % vs 50 %; P = .001], respectively). AHD was also improved in the PRS group (8.4 [7-9.5] vs 7.85 [5.5-9]; P < .05). ROM was greater in the PRS group at final follow-up with median forward flexion degree, 140.0° (90°-150°) versus 120.0° (80°-153°) (P < .001) and median abduction degree, 100.0° (70°-130°) versus 90.0° (70°-110°). There was no difference in terms of external rotation between groups (3° [2°-5°] vs 3.0° (2°-4°); P = .4).ConclusionsArthroscopic partial RCR with implantation of a subacromial spacer leads to satisfactory clinical and radiographic outcomes in patients with symptomatic irreparable MRCT compared with patients treated with partial repair alone.Level of evidenceLevel III, retrospective comparative study.

Project description:PurposeTo determine the clinical, biomechanical, and financial impact of the use of subacromial balloon spacers in the surgical management of massive, irreparable rotator cuff tears (RCTs).MethodsAll studies assessing the use of implantable subacromial balloon spacers for management of massive, irreparable RCTs were systematically searched. Risk of bias was assessed using Methodological Index for Non-Randomized Studies criteria. Data extraction and analysis was performed for pain and function scores, shoulder range of motion (ROM), glenohumeral contact pressure and vertical migration of humeral head, and cost. Subjective synthesis was performed with forest plots when outcomes were reported in 3 or more studies.ResultsIn total, 19 studies met inclusion criteria for analysis; 337 patients (mean age 68 years) had 343 subacromial balloon spacer implantations. Throughout a mean follow-up of 33 months, there was significant improvement in the Total Constant Score (preoperative: 22.5-41.8; postoperative: 51.4-72.3), Oxford Shoulder Score (preoperative: 21.3-26; postoperative: 34.39-48.2), American Shoulder and Elbow Surgeons score (preoperative: 24.5-59.1; postoperative: 72.5-85.7), and shoulder ROM parameters. Subacromial balloon spacer placement resisted superior humeral head migration (range of preoperative to postoperative difference: 2.8-6.2 mm) and decreased peak subacromial pressure during shoulder ROM.ConclusionsExisting literature of subacromial balloon spacers has a high risk of bias, lack of appropriate control, and low levels of evidence. A qualitative synthesis indicates that subacromial balloon spacer implantation in patients with massive irreparable RCTs is cost-effective and leads to improved function (Total Constant Score and Oxford Shoulder Score) and ROM. In cadaveric studies, subacromial balloon spacers resist superior humeral head migration and reduce subacromial pressure. The theoretical risk of biodegradation of the balloon spacer has not been substantiated in study of up to 5-years follow-up, and the risk of complications from this procedure appears to be minimal.Level of evidenceIV; Systematic review of level III-IV studies.

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New solution for massive, irreparable rotator cuff tears: the subacromial "biodegradable spacer".

Publications

New solution for massive, irreparable rotator cuff tears: the subacromial "biodegradable spacer".

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