NCT03584542RecruitingPhase 2
Influence Of Zoledronic Acid On Healing After Arthroskopic Repair Of Chronic Rotator Cuff Lesions A Prospective, Randomized, Placebo-Controlled Phase II Trial ZORRO
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 15 Jan 2025
- Lead sponsor
- AUVA Trauma Center Vienna
- Diseases
- Osteoporosis
- NCT number
- NCT03584542
- EU CT number
- 2024-519082-22-00
- EudraCT number
- 2022-001750-29
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AUVA Trauma Center Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.