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.,
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)
Jakob Schanda
Vienna, Austria
RECRUITINGTendon integrity of the rotator cuff by means of magnetic resonance imaging.
postoperative anatomically regular tendon thickness comparable to an intact tendon.
Time frame: 8 years
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