Subacromial Spacer Research Articles

Comparative cost-effectiveness analysis of the subacromial spacer for irreparable and massive rotator cuff tears

PurposeThere is ongoing debate regarding the optimal surgical treatment of irreparable rotator cuff tears (IRCT). This study aimed to assess within the Italian health care system the cost-effectiveness of subacromial spacer as a treatment modality for patients with IRCT.MethodsAn expected-value decision analysis was created comparing costs and outcomes of patients undergoing arthroscopic subacromial spacer implantation, rotator cuff repair (RCR), total shoulder arthroplasty, and conservative treatment for IRCTs. A broad literature search provided input data to extrapolate and inform treatment success and failure rates, costs, and health utility states for these outcomes. The primary outcome assessed was an incremental cost-effectiveness ratio (ICER) of subacromial spacer implantation versus shoulder arthroplasty, RCR, and conservative treatment.ResultsSubacromial spacer is favorable over both arthroscopic partial repair and shoulder arthroplasty since it costs less than both options and increases effectiveness by 0.06 and 0.10 quality-adjusted life years (QALYs), respectively. While conservative treatment is the least costly management strategy, subacromial spacer results in a gain of 0.05 QALYs for the additional cost of 522 €, resulting in an ICER of 10,440 €/QALY gain, which is below the standard willingness to pay ratio of $50,000 USD. Strategies with an ICER of less than 50,000 USD are considered to be cost-effective.ConclusionsBased on the available evidence and reasonably conservative assumptions, subacromial spacer is likely to provide a safe, effective, and cost-effective option for patients with massive IRCTs. Furthermore, this cost-effectiveness analysis may ultimately serve as a guide for development of health care system and insurer policy as well as clinical practice.

Current concepts in the primary management of irreparable posterosuperior rotator cuff tears without arthritis.

Various procedures exist for patients with irreparable posterosuperior rotator cuff tears (IRCT). At present, no single surgical option has demonstrated clinical superiority.There is no panacea for treatment and patients must be aware, in cases of palliative or non-prosthetic options, of an alarming rate of structural failure (around 50%) in the short term.The current review does not support the initial use of complex and expensive techniques in the management of posterosuperior IRCT.Further prospective and comparative studies with large cohort populations and long-term follow-up are necessary to establish effectiveness of expensive or complicated procedures such as superior capsular reconstruction (SCR), subacromial spacers or biological augmentation as reliable and useful alternative treatments for IRCT.Cite this article: EFORT Open Rev 2018;3 DOI: 10.1302/2058-5241.3.180002

Sub-acromial balloon spacer for irreparable rotator cuff tears: Is it an appropriate salvage procedure?

Irreparable rotator cuff tear (RCT) presents a difficult treatment challenge for the orthopaedic surgeon. Many treatment strategies with varying degrees of success have been performed over the years. One of the suggested surgical treatment options is the use of a biodegradable sub-acromial balloon spacer. A retrospective study of patients treated with sub-acromial balloon spacer between the years 2011 and 2016 was conducted. Mean follow-up time was 14.4 months. Patient charts were reviewed to evaluate the early clinical results and complications of sub-acromial spacer for irreparable RCTs. The study cohort included 24 shoulders in 22 patients. The average postoperative Disability of the Arm, Shoulder and Hand score was 62.4. The average preoperative University of California at Los-Angeles Shoulder score was 10.9 and improved to 15.9 ( p = 0.001). Forty-six per cent of patients were satisfied with their clinical postoperative outcome. We found moderate-strong positive correlation ( r = 0.64) between preoperative range of motion (ROM) and general satisfaction. None of the postoperative radiographs showed an improvement regarding the proximal migration of the humeral head. In total, four (16.7%) patients experienced postoperative complications, and two (8.3%) patients required an additional surgery as a consequence of a postoperative complication. Our results show unsatisfactory improvement in patients with irreparable RCT treated with the sub-acromial balloon spacer. Careful patient selection with attention to preoperative ROM should be considered. Therapeutic level IV.

Biceps Tenotomy Does not Affect the Functional Outcomes of Patients Treated with Spacer Implantation Due to Massive Irreparable Rotator Cuff Tears

Background:Lesions of the long head of the biceps (LHB) tendon are frequently associated with massive rotator cuff tears (RCT) and may be responsible for shoulder pain and disability.Objective:This study aimed to evaluate functional outcomes of arthroscopic biodegradable spacer implantation with or without biceps tenotomy as treatment for persistent shoulder dysfunction and pain due to a massive irreparable RCT.Methods:A total of 48 patients were implanted with the subacromial spacer using arthroscopic approach with or without biceps tenotomy. All patients were assessed for up to 12 months post-implantation and 18 patients were assessed for at least 24 months (and a maximum of 40 months). Improvement in shoulder function was assessed using Constant score.Results:Subacromial spacer implantation was performed arthroscopically in 48 patients. The mean total Constant score increased from 36 at baseline to 67 points at 12 months post implantation. Patients who underwent LHB tenotomy in addition to the subacromial spacer presented similar improvement of their shoulder function and score compared to the group that was treated with the spacer alone.Conclusion:Current study demonstrates that spacer implantation in this patient population provides significant improvement in function and decreases the pain. Additional LHB tenotomy did not influence the postoperative results during the follow-up.

Biodegradable spacer reduces the subacromial pressure: A biomechanical cadaver study

BackgroundFailure after rotator cuff repair remains a major clinical problem and could be related to excessive pressures from the acromion. Previous studies with irreparable tears showed good clinical results of tendon healing with arthroscopic insertion of a protective biodegradable spacer balloon between the repaired tendon and the acromion. One hypothesis is that compression pressures on the repaired tendon will be reduced by the spacer. This cadaver study aimed to investigate the effects of this subacromial spacer on compression pressures over a repaired supraspinatus tendon in passive motion. MethodsRotator cuff tear and repair were performed in six fresh-frozen cadaveric shoulders, followed by insertion of a biodegradable subacromial spacer. Specimens were tested using a passive shoulder simulator for abduction-adduction, flexion-extension and internal-external rotations. A sensor positioned below the acromion was used to measure compression pressure changes through passive range of motion before and after placement of a subacromial spacer. Peak pressures were measured in adduction-abduction motion, near 90° abduction. FindingsBoth the mean and peak pressures in abduction-adduction were significantly reduced after insertion of the subacromial spacer (from mean 121.7 (SD 9.5) MPa to 51.5 (SD 1.2) MPa and from peak 1749.6 (SD 80.7) MPa to 535.1 (SD 27.6) MPa) (P<0.0001). InterpretationThe reduced peak pressures and wider load distributions over the sensor during both passive abduction-adduction and flexion-extension motions suggest that the use of the spacer will lead to reduced wear of the repair in patients, and potentially prevent rotator cuff re-tear after surgical repair.

A clinical and radiological study of biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tears.

The aim of this retrospective study was to report the clinical and radiographic results of the biodegradable subacromial spacer (InSpace Balloon®) implantation in patients with massive irreparable rotator cuff tears. From February 2014 to October 2015, 30 patients affected by massive irreparable rotator cuff tears were treated with the implantation of InSpace Balloon®. Clinical evaluation (Constant Score and VAS), X-rays and MR imaging were performed preoperatively in all patients and 3, 6, 12 and 24 months after surgery, dividing patients in different groups according to the time elapsed from surgery. Constant Score increased from 39.89 to 62.33 points (p 0.0002) in the 6 months group and from 41.66 to 65.38 points (p< 0.0001) in the 12 months group. ROM (Range of Movement) and ADL (Activity of Daily Living) significantly improved with the contemporary reduction of VAS and pain at 12 months and, furthermore, an increase of functional performance with reduction of pain was registered at 24 months. Our results supported the surgical procedure of the arthroscopic implantation of biodegradable subacromial InSpace Balloon® for irreparable massive cuff tears in worker patients and with recreational activities' demands in order to recover the shoulder function with a reduction of the pain.

Subacromial Spacer for Irreparable Rotator Cuff Tears

Irreparable rotator cuff tears are a challenging clinical entity in orthopedics without a consensus treatment option. A multitude of surgical techniques have been employed in treating this condition including subacromial decompression, partial rotator cuff repair, tendon transfers, patch augmentation, superior capsular reconstruction (SCR), and reverse total shoulder arthroplasty. In use since 2008, the InSpace subacromial spacer is a novel treatment option that is implanted between the humeral head and acromion to restore normal acromiohumeral distance, permit frictionless gliding, and promote more normal shoulder mechanics. This exciting innovation is minimally invasive, easy to insert, and associated with encouraging early results. Made of a biodegradable polymer, the InSpace has been shown to be safe and to fully resorb within 1 year of implantation. The InSpace is being studied extensively in Europe and the United States; however, it is not currently FDA approved for broad use in the United States.

Arthroscopic Subacromial Spacer Implantation in Patients With Massive Irreparable Rotator Cuff Tears: Clinical and Radiographic Results of 39 Retrospectives Cases

To evaluate the clinical and radiographic outcome of a biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tear. Between January 2011 and December 2014, all shoulders with symptomatic massive irreparable rotator cuff tears treated at our institution with arthroscopic implantation of a biodegradable subacromial spacer followed for at least 1year were included in our series. Patients with osteoarthritis ≥ grade 3 in the Hamada classification were excluded. Outcome measures included pre- and postoperative, range of motion, Constant score, acromiohumeral distance, and Hamada classification on anteroposterior and lateral radiographs. Thirty-nine consecutive shoulders (37 patients) met the inclusion criteria. The mean age of patients was 69.8 (53-84) years. At the last follow-up (mean 32.8 ± 12.4months), range of motion was significantly increased for all patients in anterior elevation (from 130° to 160°, P= .02), abduction (from 100° to 160°, P= .01), and external rotation (from 30° to 45°, P=.0001). The mean Constant score was also significantly (P < .001) improved from 44.8 (±15.2) preoperatively to 76.0 (±17.1) at the last follow-up. The mean acromiohumeral distance significantly (P= .002) decreased from 8.2mm (±3.4) to 6.2mm (±3.1) at the last follow-up. The Hamada score progressed of 1 radiographic stage in 4 shoulders (15%) and progressed of 3 stages in 2 (4%), whereas the other 32 shoulders remained stable. No intra- or postoperative complications were found except for 1 patient who required a revision for spacer migration. Arthroscopic implantation of a subacromial spacer for irreparable rotator cuff tear leads to significant improvement in shoulder function at a minimum of 1year postoperatively. Level IV, therapeutic case series; treatment study.

Erratum to: Subacromial spacer implantation for massive rotator cuff tears

Erratum to: Subacromial spacer implantation for massive rotator cuff tears

Subacromial spacer implantation for massive rotator cuff tears: Clinical outcome of arthroscopically treated patients.

BackgroundMassive rotator cuff tears (MRCT) can be treated arthroscopically by partial reconstruction, tenotomy/tenodesis of the long head of the biceps, and debridement. A new treatment option is the additional implantation of a biodegradable spacer (InSpace Balloon®; ISB) into the subacromial space, which reduces subacromial shear forces to keep the humeral head centered in the glenoid. The aim of this study is to investigate the clinical outcome of patients with MRCT who were treated arthroscopically with or without an additional ISB.MethodsThe clinical outcome of patients treated with conventional arthroscopic techniques (n = 11, group A, partial repair, biceps tenotomy, and debridement) and that of patients treated with a supplementary ISB (n = 12, group B) was retrospectively analyzed. Preoperatively and postoperatively, shoulder function was assessed with the Constant and American Shoulder and Elbow Surgeons (ASES) scores. At follow-up after a mean of 22 months, patients filled out a questionnaire about their subjective satisfaction.ResultsPreoperative shoulder function was lower in patients treated with an ISB (ASES score: group A, 59.1; group B, 31.5; Constant score: group A, 60.7; group B, 36.8). At follow-up, both groups had improved shoulder function (Constant score: group A, 60.7–77.6; p < 0.001; group B, 36.8–69.5; p < 0.001; ASES score: group A, 59.1–88.6; p < 0.001; group B, 31.5–85.7; p < 0.001). Patients in both groups were subjectively satisfied with their outcome.ConclusionThe ISB is a feasible treatment option for MRCT, providing subjective pain relief and improved shoulder function. Further studies with larger patient collectives and longer follow-up are needed to confirm whether it is a safe and cost-effective treatment.

Augmented Fixation With Biodegradable Subacromial Spacer After Repair of Massive Rotator Cuff Tear

Unsuccessful outcomes after repair of massive rotator cuff ruptures accompanied by muscle atrophy and fatty degeneration are frequently associated with inadequate management and secondary tears. We report the functional differences after rotator cuff rupture repair with a biodegradable spacer application. In these patients, rotator cuff rupture repair should provide coverage of the humeral head. Subsequently, acromioplasty should be performed to allow adequate space for the subacromial spacer. Thereafter measurement of the intra-articular space required for application of the biodegradable spacer is performed. Using this method can decrease the rate of tears by providing a safe subacromial space in cases of massive rotator cuff rupture.

Subacromial Spacer Placement for Protection of Rotator Cuff Repair

Rotator cuff repairs have a high failure rate proportional to the tear size. Various techniques have been described to improve the repair strength and failure rate. The described surgical technique uses a biodegradable subacromial balloon-shaped spacer (InSpace; OrthoSpace, Caesarea, Israel) that is implanted arthroscopically to protect our tendon repair. We describe the introduction technique and suggest some hints and tricks. The spacer is placed under direct vision in the subacromial space after the rotator cuff repair is finished. Correct placement is verified by moving the arm freely. The subacromial spacer may help to protect the rotator cuff repair by centering the humeral head and reducing friction between suture knots and the acromion. It may also help to flatten dog-ear formations.

Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears

The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpace™) implantation in patients with massive irreparable rotator cuff tear and to determine the safety profile and functional results 3years post-implantation. Twenty patients were implanted with the InSpace™ device and assessed up to 3years of post-implantation. Improvement in shoulder function was assessed using Constant score, while ease of use of the system was recorded by surgeons as were device-related adverse events. Twenty patients were available for assessment. Implantation was performed arthroscopically in all patients, and a range of deployment time was 2-20min. The mean total Constant score increased from 33.4 to 65.4 points at 3years. There was an improvement of 6.4 points in subjective pain score which commenced at 1week post-operatively and was sustained until 3years of follow-up. Also activities of daily living and motions commenced improvement by 9.4 and 7.7 points, respectively. Improvement in power was only evident at 18months of follow-up but was sustained at 3years. Arthroscopic deployment of a co-polymer biodegradable spacer (balloon) into the sub-acromial space for an irreparable rotator cuff tear was found to be low-risk and simple procedure associated with improvement in shoulder function and low rate of complications. IV; therapeutic case series.

Prosthetic Arthroplasties of the Shoulder

CLAYTON, MACK L. M.D.; FERLIC, DONALD C. M.D.; JEFFERS, PHILLIP D. M.D.Editor(s): BANKS, HENRY H. Author Information