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

AUVA Traumazentrum Vienna Site UKH Meidling

Status and phase: Enrolling; Phase 2

Conditions: Orthopedics; Traumatology

Treatments: Drug: Intravenous Infusion of Aclasta®

Study type: Interventional

Funder types: Other

Identifiers

NCT05677152

ZORRO

Details and patient eligibility

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.,

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Zoledronic Acid

Active Comparator group

Description:

zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum

Treatment:

Drug: Intravenous Infusion of Aclasta®

physiological saline solution 0.9%

Placebo Comparator group

Description:

Sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml): Placebo

Treatment:

Drug: Intravenous Infusion of Aclasta®