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.,
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
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
Parallel
Intravenous Infusion of Aclasta®
DrugIntravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)
Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
postoperative anatomically regular tendon thickness comparable to an intact tendon.
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AUVA Traumazentrum Vienna Site UKH Meidling
Lead sponsor
AUVA Trauma Center Meidling
Sponsor institution
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
Collaborator
