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

Study Overview
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Brief Summary
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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.,

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

Conditions
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Orthopedics, Traumatology

Intervention / Treatment
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* Drug: Intravenous Infusion of Aclasta®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo controlled trial (Zoledronic acid versus Placebo), randomized, 2 Teams: unblinded and blinded
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zoledronic acid, chronic rotator cuff tears, arthroscopic repair