Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears

Abstract

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.

Implantable Subacromial Balloon Spacers in Patients With Massive Irreparable Rotator Cuff Tears: A Systematic Review of Clinical, Biomechanical, and Financial Implications

“…In terms of VAS pain scores, Ricci et al 44 found significant improvement in VAS scores in those groups with 3-(6.13-3.38, P ¼ .0005), 6-(6.45-3.67, P ¼ .0019), 12-(6.25-2.86, P ¼ .0001), and 24-month (6.6-2.8, P ¼ .0019) follow-up. Gervasi et al 7 demonstrated similar findings at 12-month (7.1-1.4, P < .0001) and 24-month (7.1-2.1, P < .0001) follow-up. 40 also demonstrated significant improvement in VAS score at rest, at night, and during activity following both partial rotator cuff repair with implantation of the balloon spacer and implantation of balloon spacer alone, with no significant difference in VAS scores between intervention groups.…”

“…24 Reported advantages of this device are its minimal technical demands and shorter operative duration, 7,24,25 evidence of expedited postoperative shoulder mobility, 26 and improved postoperative clinical function scores, such as Total Constant Score (TCS), American Shoulder and Elbow Surgeons (ASES) score, and Oxford Shoulder Score (OSS) in patients, [27][28][29] and the ability to implant the device under fluoroscopic guidance without general anesthesia in those patients with medical contraindications. 7,25 Recent systematic reviews by Moon et al 29 and Stewart et al 30 demonstrated improvements in patient satisfaction and clinical outcomes such as TCS and ASES in patients managed with subacromial balloon spacers. However, there is limited research regarding the potential biomechanical and clinical advantages in addition to the cost associated with subacromial balloon spacers in a systematic review.…”

Subacromial Balloon Interpositional Arthroplasty for the Management of Irreparable Rotator Cuff Tears: Five-year Results

“…This may have a huge bearing on patients not able to withstand prolonged anaesthesia. We also note a case series in literature describing insertion of this subacromial implant under local anaesthesia under image intensifier guidance [19]. This will undoubtedly further extend the indications of this implant to patients who are not medically fit for surgery under general anesthesia.…”

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

“…Although several studies [ 14 , 15 ] have been conducted to evaluate the cost-effectiveness analysis of various treatments for IRCTs, including rTSA, partial repair, and non-operative care, to our knowledge, this is the first evaluation of InSpace™, an emerging technology. Recent publications [ 16 , 17 ] have presented positive efficacy and safety outcomes with InSpace™ over varying periods of time, and coupling with our cost-effectiveness analysis also adds to the knowledge base regarding the benefits of this IRCT treatment compared to other alternatives.…”