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

Orthopedics Clinical Trial

— ZORRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677152
• Other study ID #: ZORRO
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Orthopedics
• Traumatology

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