Intraoperative Zoledronic Acid for Arthroscopic Rotator Cuff Repair: Short-Term Results From a Prospective, Randomized, Placebo-Controlled Phase II Trial.
Jakob E Schanda, Roman Ullrich, Sandra Boesmueller...
https://pubmed.ncbi.nlm.nih.gov/41549490Actively Recruiting
Phase 2
Age: 50Years - 70Years
All Genders
ID05677152
Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
Led by AUVA Traumazentrum Vienna Site UKH Meidling · Updated on 2024-03-18
80
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
Sponsors
A
AUVA Traumazentrum Vienna Site UKH Meidling
Lead Sponsor
L
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether an additional intravenous treatment with zoledronic acid can improve tendon healing after arthroscopic surgery for chronic rotator cuff tears. This phase II, prospective, placebo-controlled study focuses on adults aged 50 to 70 years who have verified rotator cuff tears. The study is supported by the General Accident Insurance Institution (AUVA) and aims to prove the benefit of zoledronic acid compared to no additional therapy. Participants are randomly assigned to receive either a single intravenous infusion of 5 mg zoledronic acid (Aclasta ) or a placebo infusion of physiological saline solution (100 ml). Both treatments are given once, and the study is double-blinded. The primary treatment period includes the surgery and study infusion, followed by a standardized physiotherapy program using a shoulder abduction pad for four weeks after surgery. Throughout the study, tendon healing is monitored primarily through magnetic resonance imaging over an eight-year period to assess rotator cuff tendon integrity. Participants will undergo regular evaluations, including imaging and clinical assessments, to track healing progress. The study also involves long-term follow-up to observe the outcomes of the adjuvant therapy on tendon repair after the surgical procedure.
CONDITIONS
Brief Title
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Who Can Participate
Age: 50Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 50 and 70 years
- Rotator cuff tear verified by magnetic resonance imaging within 6 months prior to surgery
- Rupture size with a maximum diameter of 3 cm
- Willingness to participate in the study
- Willingness to follow a standardized physiotherapy program using a shoulder abduction pad for four weeks after surgery
You will not qualify if you...
- Patients younger than 50 or older than 70 years
- Pregnancy
- Known allergy to zoledronic acid or 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 with fasting glucose 126 mg/dl or HbA1c 6.5%
- Malignant tumor disease
- Pathological dental status
- Known diseases interfering with bone metabolism
- Concomitant diseases preventing general anesthesia
- Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)
- Epilepsy
- Claustrophobia
- Chronic alcohol abuse
- Drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to 2 weeks or until discharge
Participants undergo arthroscopic repair of chronic rotator cuff lesions followed by immediate care after surgery.
Treatment
Duration - Single administration post-surgery
Participants receive a single intravenous infusion of zoledronic acid or placebo after surgery.
1 infusion visit (in-person)
Post-operative Follow-up
Duration - 4 weeks after surgery
Participants follow a standardized physiotherapy program using a shoulder abduction pad for four weeks after surgery and receive ongoing assessments of tendon healing.
Weekly visits during physiotherapy
Long-term Monitoring
Duration - Up to 8 years
Participants are monitored for tendon integrity of the rotator cuff by magnetic resonance imaging over an extended period.
Periodic imaging visits
Trial Site Locations
Total: 1 location
1
Jakob Schanda
Vienna, Austria, 1120
Actively Recruiting
Loading map...
Research Team
J
Jakob Schanda, DDr.
O
Ortrun Neuper, MSc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here