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.

Long-term Local and Systemic Safety of Poly(l-lactide-co-epsilon-caprolactone) after Subcutaneous and Intra-articular Implantation in Rats

“…Implanted test devices were produced using the manufacturing process and full ethylene oxide sterilization cycles identical to the device as used in humans, but downsized to accommodate animal size. In humans, the device is available in 3 different sizes: small (40 Â 50 mm), medium (50 Â 60 mm), and large (60 Â 70 mm; Savarese and Romeo 2012). For the shoulder implantation (first study), 2-layer films, sized to 5 Â 5 mm to accommodate rat shoulder size, were used.…”

“…A novel addition to the biodegradable armamentarium for RC syndrome includes a subacromial implantable balloonshaped spacer (InSpace™ system, Ortho-Space, Caesarea, Israel), which, when implanted between the humeral head and acromion, permits smooth, frictionless gliding, supporting shoulder biomechanics (Anley, Chan, and Snow 2014;Gervasi, Cautero, and Dekel 2014;Savarese and Romeo 2012;Szollosy et al 2014). This device, which is intended for arthroscopic or mini-open insertion in humans, has proven to treat shoulder pain and improve range of motion when implanted in patients with massive irreparable RC tears (Senekovic et al 2013).…”

Fluoroscopy-Guided Implantation of Subacromial “Biodegradable Spacer” Using Local Anesthesia in Patients With Irreparable Rotator Cuff Tear

“…Use of the innovative InSpace device has been reported as an arthroscopic technique, 8 and a clinical study of 20 patients with massive irreparable RCTs (11 men and 9 women; mean age, 70.5 years; age range, 54 to 85 years) with a 3-year postoperative follow-up period showed significant improvement in total Constant score (P < .0001) at final follow-up. 9 The fluoroscopy-guided insertion of the InSpace spacer with patients under local anesthesia provides a simple, minimally invasive option for treatment of massive RCTs.…”

Options Before Reverse Total Shoulder Replacement

“…One of the most recent treatment modalities proposed for an irreparable rotator cuff tears is the use of a subacromial balloon or spacer [89]. The most commonly used balloon system which contains an introducer and a presbaped spacer (available in 3 different sizes) made of poly(l-lactide-co-caprolactone), which is a copolymer of poly-lactide and -caprolactone.…”