NCT05677152

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

Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: AUVA Traumazentrum Vienna Site UKH Meidling · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.,

Conditions

• Orthopedics
• Traumatology

Interventions

Type	Name	Description
DRUG	Intravenous Infusion of Aclasta®	Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)

Timeline

• Start date: 2022-08-22
• Primary completion: 2025-07-01
• Completion: 2030-12-01
• First posted: 2023-01-10
• Last updated: 2024-03-18

Locations

1 site across 1 country: Austria