We conclude that in this initial cohort, arthroscopic implantation of InSpace™ system represented an effective alternative to the existing arthroscopic procedures in patients with painful massive RCT refractory to conservative management. Further randomized controlled trials comparing the clinical and functional outcomes after implantation of the InSpace™ device are warranted.

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Background The management of massive rotator cuff tears (MRCTs) is challenging and associated with a high failure rates. Studies have shown that advanced age, lower American Society of Anesthesiologists physical status score and concomitant comorbidities are associated with higher risks of death and postoperative complications. This study was designed to assess the safety and efficacy of fluoroscopy-guided biodegradable spacer implantation under local anesthesia, in patients with MRCT and comorbidities completely or partially contraindicating surgeries under general anesthesia.MethodsIn this open-label, single arm, prospective study, subjects with MRCTs underwent subacromial fluoroscopy-guided implantation with a biodegradable spacer (InSpace™ system) under local anesthesia. Fifteen patients were treated and assessed. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Constant (CS) and American Shoulder and Elbow Society (ASES) scores.ResultsAll patients demonstrated an overall improvement in the total CS and ASES beginning at 6 weeks and sustained by at least 12 months postoperatively. Of the 15 patients who reached the 1-year follow-up, 85% showed a clinically significant improvement of at least 15 points in their Constant score starting at 6 weeks postoperation and maintained throughout the entire follow-up period.ConclusionsWe conclude that in this initial patient’s cohort, fluoroscopy-guided implantation of InSpace™ system under local anesthesia, represented an effective alternative to the existing procedures. This procedure may be considered as a treatment option for elderly patients or for patients with multiple comorbidities complicating or contraindicating surgery under general anesthesia. Technically easy, this technique can be an effective tool in the armamentarium of most orthopedic surgeons. Level of proof: single-arm prospective study, Level II.

The use of biodegradable materials is gaining popularity in medicine, especially in orthopedic applications. However, preclinical evaluation of biodegradable materials can be challenging, since they are located in close contact with host tissues and might be implanted for a long period of time. Evaluation of these compounds requires biodegradability and biocompatibility studies and meticulous pathology examination. We describe 2 preclinical studies performed on Sprague-Dawley rats for 52 weeks, to evaluate clinical pathology, biocompatibility, biodegradability, and systemic toxicity after implantation of 2-layered films or saline-inflated balloon-shaped implants of downsized InSpace™ devices (termed ''test device''). The test devices are made from a copolymer of poly-L-lactide-co-e-caprolactone in a 70:30 ratio, identical to the device used in humans, intended for the treatment of rotator cuff tears. Intra-articular film implantation and subcutaneous implantation of the downsized device showed favorable local and systemic tolerability. Although the implanted materials have no inherent toxic or tumorigenic properties, one animal developed a fibrosarcoma at the implantation site, an event that is associated with a rodent-predilection response where solid materials cause mesenchymal neoplasms. This effect is discussed in the context of biodegradable materials along with a detailed description of expected pathology for biodegradable materials in long-term rodent studies.

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.