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

NCT05677152 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-18

No results posted yet for this study

Summary

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.,

Conditions

  • Orthopedics
  • Traumatology

Interventions

DRUG

Intravenous Infusion of Aclasta®

Intravenous Infusion of Aclasta® (Verum) or physiological saline solution 0.9% (Placebo)

Sponsors & Collaborators

  • Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

    collaborator OTHER_GOV

  • CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology

    collaborator UNKNOWN

  • AUVA Traumazentrum Vienna Site UKH Meidling

    lead OTHER

Principal Investigators

  • Jakob Schanda, DDr. · AUVA Traumazentrum Vienna Site UKH Meidling

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2025-07-31
Completion
2030-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677152 on ClinicalTrials.gov