Effect of zoledronic acid on healing after shoulder surgery
Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
This study tests if a single dose of zoledronic acid can help people aged 50 to 70 heal better after shoulder surgery for rotator cuff tears compared to those who get a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | AUVA Traumazentrum Vienna Site UKH Meidling Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05677152 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the impact of a single intravenous dose of zoledronic acid on the healing process following arthroscopic repair of chronic rotator cuff tears. The study is designed as a prospective, single-center, placebo-controlled trial, comparing outcomes between patients receiving the drug and those receiving a placebo. The primary focus is to determine if the adjuvant therapy enhances tendon healing in patients aged 50 to 70 years with specific criteria for rotator cuff injuries.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 70 years with a verified rotator cuff tear of a specific size who are willing to participate in the study and follow post-operative rehabilitation protocols.
Not a fit: Patients outside the age range of 50 to 70 years, those with certain pre-existing conditions, or those with more severe rotator cuff injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing surgery for chronic rotator cuff tears.
How similar studies have performed: While the use of zoledronic acid in this context is novel, similar studies in other orthopedic applications have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna
- Jakob Schanda — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Jakob Schanda, DDr. — AUVA Traumazentrum Vienna Site UKH Meidling
- Study coordinator: Jakob Schanda, DDr.
- Email: jakob.schanda@auva.at
- Phone: +435939345201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.