2015 ISAKOS Biennial Congress ePoster #2403

Biodegradable Inflatable Spacer As A Novel Treatment For Massive Rotator Cuff Tears: Prospective Multi-Center Study

Eran Maman, MD, Kiriyat Ono ISRAEL
Eliyahu Adar, MD, Karmey Josef, Israel ISRAEL
Assaf Dekel, MD, Tel Aviv ISRAEL
Ori Safran, MD, Jerusalem ISRAEL
Shaul Beyth, MD, Tel Aviv ISRAEL
Ofer Rak, MD, Ramat Hasharon ISRAEL
Gavriel Mozes, MD, Tel Aviv ISRAEL

Multi-Center Study, Multi-Center Study, ISRAEL

The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use: Ortho-Space, biodegradable sub-acromial spacer (InSpaceā„¢)

Summary: The biodegradable inflatable spacer implantation in patients with massive RCT is apparently a low risk procedure, associated with improvement in shoulder function and low complications rate

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Abstract:

Introduction

The management of massive, irreparable rotator cuff tears (RCT) is challenging and associated with a high failure rates.The biodegradable inflatable spacer used in this study is made of a copolymer (Poly-L-Lactide-co- epsilon -caprolactone). Subacromial implantation of the spacer allows smooth gliding of the humeral head against the acromion and improves shoulder function in patients with massive RCT. The purposes of this prospective non-randomized study were to confirm the feasibility of the biodegradable sub-acromial spacer (InSpaceā„¢) implantation in patients with massive irreparable RCT and to determine the safety profile and functional results.

Material And Methods

In this open-label, single arm, multi-center prospective study, patients with massive RCT underwent implantation with the biodegradable inflatable sub-acromial spacer. Follow-up visits were scheduled according to routine clinical practice to assess safety and efficacy. Shoulder function evaluated using the Total Constant Score (TCS).

Results

In 4 medical centers, 50 patients with successful device implantation were included.(23 male, ages 57-82, mean 69.7 yrs). Of these patients, 32 (64%) completed a minimum of 6 months follow-up and 30 (46%) completed 1 year. The biodegradable spacer was inserted arthroscopically in 48 cases and with a mini-open approach in 2 cases. Prior to implantation, 33 patients (66%) underwent debridement or arthroscopic subacromial decompression (ASD) while 15 (33%) underwent ASD plus tenotomy of the long head of the biceps. The mean TCS change from baseline to last follow-up was 31 points (SD 3.03., p<.0001). At 6 month follow- up 68.8% (22/32) of the subjects showed at least 20 points of improvement in their TCS, this improvement sustained at one year. 42 subjects (84%) patients had reduction in pain, including decrease of nocturnal pain in 37 cases (74%). 40 subjects (80%) reported improvement in their daily activities and range of movement (p<.0001).

Two device related events (4%) occurred. Displacement in one case and device removal due to deterioration in shoulder function. Three cases (6%) of local inflammation/suspected aseptic synovitis were reported.

Conclusions

The biodegradable inflatable spacer implantation in patients with massive RCT is apparently a low risk procedure, associated with improvement in shoulder function and low complications rate. The benefits of using biodegradable spacer should be confirmed in further randomized controlled studies, during a longer follow-up period.