Actively Recruiting
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Led by AUVA Traumazentrum Vienna Site UKH Meidling · Updated on 2024-03-18
80
Participants Needed
1
Research Sites
431 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
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.,
CONDITIONS
Official Title
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 70 years
- Magnetic resonance imaging verified rotator cuff tear within 6 months 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 using a shoulder abduction pad for four weeks postoperatively
You will not qualify if you...
- 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 26 126 mg/dl, HbA1C 26 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jakob Schanda
Vienna, Austria, 1120
Actively Recruiting
Research Team
J
Jakob Schanda, DDr.
CONTACT
O
Ortrun Neuper, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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