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

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.,

Inclusion CriteriaAge between 50 and 70 yearsMagnetic resonance imaging verified rotator cuff tear (within 6 month prior to surgery)Rupture size with a maximum diameter of 3 cmWillingness to participate in the studyWillingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperativelExclusion Criteria:Patients younger than 50 or older than 70 years of agePregnancyKnown allergy to zoledronic acid or other components of the medicinal productPrevious fracture of the affected shoulderPrevious surgery of the affected shoulderPrevious or existing bacterial infection of the affected shoulderRupture of more than two tendons in the affected shoulder (massive rotator cuff tear)Isolated subscapularis tendon tearPresence 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 diseasePathological dental statusKnown disease that interferes with bone metabolismConcomitant diseases that do not permit general anesthesiaPrevious therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)EpilepsyClaustrophobiaChronic alcohol abuseDrug abuse