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

NCT05677152 Phase 2 RECRUITING

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.,

Details

Lead sponsor	AUVA Traumazentrum Vienna Site UKH Meidling
Phase	Phase 2
Status	RECRUITING
Enrolment	80
Start date	2022-08-22
Completion	2030-12

Conditions

• Orthopedics
• Traumatology

Interventions

• Intravenous Infusion of Aclasta®

Primary outcomes

• Tendon integrity of the rotator cuff by means of magnetic resonance imaging. — 8 years
  postoperative anatomically regular tendon thickness comparable to an intact tendon.

Countries

Austria