Abstract
Background:
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.
Purpose/Hypothesis:
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.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
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.
Results:
At 6 months, retears were significantly lower (P = .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; P = .044). Postoperative fatty muscle infiltration of the supraspinatus was significantly lower in the zoledronic acid group compared with the control group (P < .001). Clinical and functional outcomes significantly improved in the 2 study groups 3 and 6 months postoperatively, with better outcomes for abduction (P = .002), forward flexion (P = .002), external rotation (P = .001), CMS (P < .001), ASES score (P < .001), SSV (P < .001), and VAS for pain (P < .001) in the zoledronic acid group at the final follow-up.
Conclusion:
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.
Registration:
NCT05677152 (ClinicalTrials.gov identifier).
Keywords
Get full access to this article
View all access options for this article.
References
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
