Actively Recruiting
Study of Zoledronic Acid to Improve Healing After Arthroscopic Repair of Chronic Rotator Cuff Tears in Adults Aged 50 to 70
Led by AUVA Traumazentrum Vienna Site UKH Meidling · Updated on 2024-03-18
80
Participants Needed
1
Research Sites
282 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether an additional intravenous treatment with zoledronic acid can improve tendon healing after arthroscopic surgery for chronic rotator cuff tears. This phase II, prospective, placebo-controlled study focuses on adults aged 50 to 70 years who have verified rotator cuff tears. The study is supported by the General Accident Insurance Institution AUVA and aims to prove the benefit of zoledronic acid compared to no additional therapy. Participants are randomly assigned to receive either a single intravenous infusion of 5 mg zoledronic acid Aclasta or a placebo infusion of physiological saline solution 100 ml. Both treatments are given once, and the study is double-blinded. The primary treatment period includes the surgery and study infusion, followed by a standardized physiotherapy program using a shoulder abduction pad for four weeks after surgery. Throughout the study, tendon healing is monitored primarily through magnetic resonance imaging over an eight-year period to assess rotator cuff tendon integrity. Participants will undergo regular evaluations, including imaging and clinical assessments, to track healing progress. The study also involves long-term follow-up to observe the outcomes of the adjuvant therapy on tendon repair after the surgical procedure.
CONDITIONS
Brief Title
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Research Team
J
Jakob Schanda, DDr.
O
Ortrun Neuper, MSc.
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