Zoledronic acid for Rotator cuff tear | Osteoporosis

Inclusion criteria

• {"criterion_text":"-  Age between 50 and 70 years"}
• {"criterion_text":"-  Magnetic resonance imaging verified rotator cuff tear (within 6 months prior to surgery)"}
• {"criterion_text":"-  Rupture size with a maximum diameter of 3 cm"}
• {"criterion_text":"-  Willingness to participate in the study"}
• {"criterion_text":"-  Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperatively"}

Exclusion criteria

• {"criterion_text":"-  Patients younger than 50 or older than 70 years"}
• {"criterion_text":"-  Pregnancy"}
• {"criterion_text":"-  Known allergy to zoledronic acid or other components of the medicinal product"}
• {"criterion_text":"-  Previous fracture of the affected shoulder"}
• {"criterion_text":"-  Previous surgery of the affected shoulder"}
• {"criterion_text":"-  Previous or existing bacterial infection of the affected shoulder"}
• {"criterion_text":"-  Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear)"}
• {"criterion_text":"-  Isolated subscapularis tendon tear"}
• {"criterion_text":"-  Presence of glenohumeral osteoarthritis (Hamada type 3 or higher)"}
• {"criterion_text":"-  Diabetes mellitus (fasting glucose ≥ 126 mg/dl, HbA1C ≥ 6.5%)"}
• {"criterion_text":"-  Malignant tumor disease"}
• {"criterion_text":"-  Pathological dental status"}
• {"criterion_text":"-  Known disease that interferes with bone metabolism"}
• {"criterion_text":"-  Concomitant diseases that do not permit general anesthesia"}
• {"criterion_text":"-  Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)"}
• {"criterion_text":"-  Epilepsy"}
• {"criterion_text":"-  Claustrophobia"}
• {"criterion_text":"-  Chronic alcohol abuse"}
• {"criterion_text":"-  Drug abuse"}

Primary endpoints

• {"endpoint_text":"-  Tendon integrity 6 months postoperative (no re-rupture/re-rupture)","definition_or_measurement_approach":"Assessed by magnetic resonance imaging (MRI) at the specified postoperative timepoint to determine re-rupture / no re-rupture."}
• {"endpoint_text":"-  Tendon integrity 12, 24 and 60 months postoperative (no re-rupture/re-rupture)","definition_or_measurement_approach":"Assessed by magnetic resonance imaging (MRI) at the specified postoperative timepoints (12, 24, 60 months) to determine re-rupture / no re-rupture."}

Secondary endpoints

• {"endpoint_text":"- Fatty muscle infiltration","definition_or_measurement_approach":"Assessed by MRI at postoperative timepoints."}
• {"endpoint_text":"- shoulder abduction and adduction","definition_or_measurement_approach":"Measured by clinical examination and strength measurement at specified visits."}
• {"endpoint_text":"- shoulder anteversion and retroversion","definition_or_measurement_approach":"Measured by clinical examination at specified visits."}
• {"endpoint_text":"- shoulder rotation internal and external","definition_or_measurement_approach":"Measured by clinical examination at specified visits."}
• {"endpoint_text":"- shoulder strength","definition_or_measurement_approach":"Measured by strength measurement tests during follow-up visits."}
• {"endpoint_text":"- pain evaluation","definition_or_measurement_approach":"Assessed using clinical pain evaluation scales at follow-up visits."}
• {"endpoint_text":"- Constant-Murley-Score","definition_or_measurement_approach":"Assessed using the Constant-Murley clinical and functional questionnaire at scheduled visits."}
• {"endpoint_text":"- American Shoulder and Elbow Surgeons Score","definition_or_measurement_approach":"Assessed using the ASES questionnaire at scheduled visits."}
• {"endpoint_text":"- Subjective Shoulder Value","definition_or_measurement_approach":"Assessed using the Subjective Shoulder Value questionnaire at scheduled visits."}

Austria

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

14-01-2025

Processing Time Days

90

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

AUVA Trauma Center Vienna

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Austria