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

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

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.,

Study Overview

• Status: Recruiting
• Conditions: Traumatology; Orthopedics
• Intervention / Treatment: Drug: Intravenous Infusion of Aclasta®

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jakob Schanda, DDr.; Phone Number: +435939345201; Email: jakob.schanda@auva.at
• Study Contact Backup: Name: Ortrun Neuper, MSc.; Phone Number: +436764543334; Email: oneuper@trauma.lbg.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1120
    • Recruiting
    • Jakob Schanda
    • Contact: Jakob Schanda, DDr.; Phone Number: +435939345201; Email: jakob.schanda@auva.at
    • Contact: Ortrun Neuper, MSc.; Phone Number: +436764543334; Email: oneuper@trauma.lbg.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zoledronic Acid; zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum	Drug: Intravenous Infusion of Aclasta®; Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo); Other Names: physiological saline solution 0.9% (Placebo)
Placebo Comparator: physiological saline solution 0.9%; Sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml): Placebo	Drug: Intravenous Infusion of Aclasta®; Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo); Other Names: physiological saline solution 0.9% (Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tendon integrity of the rotator cuff by means of magnetic resonance imaging.	postoperative anatomically regular tendon thickness comparable to an intact tendon.	8 years

Collaborators and Investigators

• Sponsor: AUVA Traumazentrum Vienna Site UKH Meidling
• Collaborators: 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
• Investigators: Principal Investigator: Jakob Schanda, DDr., AUVA Traumazentrum Vienna Site UKH Meidling

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: arthroscopic repair; zoledronic acid; chronic rotator cuff tears
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: ZORRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No