Fact CheckerSign in

NCT03584542RecruitingPhase 2

Influence Of Zoledronic Acid On Healing After Arthroskopic Repair Of Chronic Rotator Cuff Lesions A Prospective, Randomized, Placebo-Controlled Phase II Trial ZORRO

Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Longitudinal investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six, twelve, twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions. Null hypothesis: Adjuvant intravenous therapy with zoledronic acid does not improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
16 Oct 2024
Start date
15 Jan 2025
Lead sponsor
AUVA Trauma Center Vienna
Diseases
Osteoporosis
NCT number
NCT03584542
EU CT number
2024-519082-22-00
EudraCT number
2022-001750-29

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  •  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  Previous surgery of the affected shoulder  Previous or existing bacterial infection of the affected shoulder  Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear)  Isolated subscapularis tendon tear  Presence of glenohumeral osteoarthritis (Hamada type 3 or higher)  Diabetes mellitus (fasting glucose ≥ 126 mg/dl, HbA1C ≥ 6.5%)  Malignant tumor disease  Pathological dental status  Known disease that interferes with bone metabolism  Concomitant diseases that do not permit general anesthesia  Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)  Epilepsy  Claustrophobia  Chronic alcohol abuse  Drug abuse

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AUVA Trauma Center Vienna
Coordinator of this site? Confirm its status
ViennaAustriaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.