INFLUENCE OF ZOLEDRONIC ACID ON HEALING AFTER ARTHROSCOPIC REPAIR OF CHRONIC ROTATOR CUFF LESIONS
Conditions
Interventions
Trade Name: Aclasta (Zoledronic Acid)
Product Name: Aclasta
Pharmaceutical Form: Infusion
INN or Proposed INN: not available
CAS Number: 165800-06-6
Current Sponsor code: not available
Other descripti
Sponsors
AUVA Trauma Center Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age between 50 and 70 years • Magnetic resonance imaging verified rotator cuff tear (done within 6 month before 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 postoperatively Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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 = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears.;Secondary Objective: not applicable;Primary end point(s): investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six months , twelve months , twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions.;Timepoint(s) of evaluation of this end point: six months, twelve months, 24 and 60 months after arthroscopic repair of chronic rotator cuff lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Examination of bone metabolism, micro-RNA , specific clinical test concerning shoulder function as well as collection of functional questionaires to investigate the muscular regeneration by zoledronic acid;Timepoint(s) of evaluation of this end point: 2 day, 4 week, 3 months, 6 months , 12 months, 24 months and 60 months after arthroscopic repair of chronic rotator cuff lesions. An interim analysis is planned after all 80 patients have completed the “3 month postoperative” visit. This will be expected between Q1/ 2025 and Q4/ 2025. | — |
Countries
Austria
Contacts
Public ContactJakob Schanda PD DDr.
AUVA Trauma Center Vienna
Outcome results
None listed