Intraoperative Zoledronic Acid for Arthroscopic Rotator Cuff Repair: Short-Term Results From a Prospective, Randomized, Placebo-Controlled Phase II Trial.

Abstract

Despite technical innovations and surgical improvements, retear rates after arthroscopic rotator cuff (RC) repair remain high. Preclinical studies demonstrated improved outcomes using bisphosphonates after RC repair. The purpose of this monocentric, prospective, randomized, placebo-controlled, triple-blinded phase II trial was to investigate retears in patients without osteoporosis undergoing arthroscopic RC repair with a systemic single-dose zoledronic acid. It was hypothesized that zoledronic acid would reduce retears after RC repair. Randomized controlled trial; Level of evidence, 1. A total of 80 patients were intraoperatively randomized to the zoledronic acid group (n = 40) or the control group (n = 40). All patients underwent magnetic resonance imaging 6 months after surgery. Range of motion, abduction strength, Constant-Murley score (CMS), American Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Value (SSV), and Visual Analog Scale (VAS) for pain were assessed preoperatively as well as 3 and 6 months after arthroscopic RC repair. At 6 months, retears were significantly lower (<i>P</i> = .001) in the zoledronic acid group (n = 6; 15%) compared with the control group (n = 14; 35%). The risk of a RC retear with an additional zoledronic acid treatment (RR, 0.43 [95% CI, 0.16; 0.98]) was significantly lower compared with that of the control group (OR, 0.328; 95% CI, 0.111-0.969; <i>P</i> = .044). Postoperative fatty muscle infiltration of the supraspinatus was significantly lower in the zoledronic acid group compared with the control group (<i>P</i> < .001). Clinical and functional outcomes significantly improved in the 2 study groups 3 and 6 months postoperatively, with better outcomes for abduction (<i>P</i> = .002), forward flexion (<i>P</i> = .002), external rotation (<i>P</i> = .001), CMS (<i>P</i> < .001), ASES score (<i>P</i> < .001), SSV (<i>P</i> < .001), and VAS for pain (<i>P</i> < .001) in the zoledronic acid group at the final follow-up. An intraoperative systemic single-dose zoledronic acid reduced retears after arthroscopic RC repair. Zoledronic acid is a safe, easy-to-apply, and cost-effective augmentation technique for patients undergoing arthroscopic RC repair. NCT05677152 (ClinicalTrials.gov identifier).