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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05677152
Other study ID # ZORRO
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 22, 2022
Est. completion date December 2030

Study information

Verified date March 2024
Source AUVA Traumazentrum Vienna Site UKH Meidling
Contact Jakob Schanda, DDr.
Phone +435939345201
Email jakob.schanda@auva.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.,


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2030
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intravenous Infusion of Aclasta®
Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)

Locations

Country Name City State
Austria Jakob Schanda Vienna

Sponsors (3)

Lead Sponsor Collaborator
AUVA Traumazentrum Vienna Site UKH Meidling CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tendon integrity of the rotator cuff by means of magnetic resonance imaging. postoperative anatomically regular tendon thickness comparable to an intact tendon. 8 years
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