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Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder

RecruitingPhase 2Ages 50 Years - 70 YearsAllAUVA Traumazentrum Vienna Site UKH Meidling
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single-center, placebo-controlled, non-comparative, phase II study to evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears. The study including its financial support was approved by the medical director of the General Accident Insurance Institution (AUVA) , Dr. Roland Frank. Hypothesis to prove: Adjuvant intravenous therapy with zoledronic acid does improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.,

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria * Age between 50 and 70 years * Magnetic resonance imaging verified rotator cuff tear (within 6 month 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 postoperativel Exclusion Criteria: * 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 ≥ ZORRO Version Draft1.0/09.05.2022 Page 6 of 42 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
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What it tests

  • Intravenous Infusion of Aclasta®
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Where

1 site
Jakob Schanda
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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