Biodegradable balloon spacer for massive irreparable rotator cuff tears is associated with improved functional outcomes, low revisions, and complications rate at minimum one year follow-up.

ABSTRACT

PURPOSE: This study was designed to investigate the efficacy of the InSpace balloon spacer with a specific focus on clinical and patient-related parameters, functional scores InSpace durability, and satisfaction in patients with massive irreparable rotator cuff tears (IRCT) at minimum one year follow-up. METHODS: Between 2010 and 2018, patients with symptomatic IRCTs were treated with InSpace balloon implantation. Demographic characteristics, concomitant procedures, and patient's reported outcomes (PROMs) were obtained as well as satisfaction rate and willingness to undergo the procedure again. Need for subsequent surgery and conversion to reverse total shoulder arthroplasty (RTSA) and time to conversion were also evaluated. RESULTS: Seventy-eight patients (mean age of 70 years, range 46-86) who underwent an InSpace (OrthoSpace, Inc., Caesarea, Israel) balloon implantation were included. Mean follow-up was 56 months (median = 49.6, range 16-129 months). Sixteen out of our 29 pseudoparalytic patients (55.2%) exceed 90° of forward flexion post-surgery with mean improvement of 73° (20-150). Patients older than 65 years of age displayed a statistically significant improved ASES score (60.6 to 46.4, P < 0.05). Patients who underwent a subscapularis (SSC) repair demonstrated a superior ASES score (63.4 compared to 50.4, P = 0.06). CONCLUSIONS: Based on the current study, spacer implantation is a low-risk, clinically effective treatment for the patients with IRCTs. Patient-specific parameters such as age, BMI, and gender should be considered during patient selection process. SSC tendon tears should be repaired if needed. Improvement in function and symptoms from this procedure may negate or delay the need for RTSA even for some of the pseudoparalytic patients.