Influence Of Zoledronic Acid On Healing After Arthroskopic Repair Of Chronic Rotator Cuff Lesions A Prospective, Randomized, Placebo-Controlled Phase II Trial ZORRO
EU CTIS ID: 2024-519082-22-00
What this study is testing
Longitudinal investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six, twelve, twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions. Null hypothesis: Adjuvant intravenous therapy with zoledronic acid does not improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 50 and 70 years Magnetic resonance imaging verified rotator cuff tear (within 6 months prior to surgery) Rupture size with a maximum diameter of 3 cm Willingness to participate in the study Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperatively
You likely can't join if
- Patients younger than 50 or older than 70 years of age Pregnancy Known allergy to zoledronic acid or other components of the medicinal product Previous fracture of the affected shoulder Previous surgery of the affected shoulder Previous or existing bacterial infection of the affected shoulder Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear) Isolated subscapularis tendon tear Presence of glenohumeral osteoarthritis (Hamada type 3 or higher) Diabetes mellitus (fasting glucose ≥ 126 mg/dl, HbA1C ≥ 6.5%) Malignant tumor disease Pathological dental status Known disease that interferes with bone metabolism Concomitant diseases that do not permit general anesthesia Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide) Epilepsy Claustrophobia Chronic alcohol abuse Drug abuse
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.