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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-70
SponsorAUVA Traumazentrum Vienna Site UKH Meidling

About this trial

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.,

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intravenous Infusion of Aclasta®

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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