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

Sponsor
AUVA Traumazentrum Vienna Site UKH Meidling (Other)
Overall Status
Recruiting
CT.gov ID
NCT05677152
Collaborator
Ludwig Boltzmann Institute for Traumatology _ The research center in cooperation with AUVA (Other), CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology (Other)
80
Enrollment
1
Location
2
Arms
34.3
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.,

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous Infusion of Aclasta®
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
placebo controlled trial (Zoledronic acid versus Placebo), randomized, 2 Teams: unblinded and blindedplacebo controlled trial (Zoledronic acid versus Placebo), randomized, 2 Teams: unblinded and blinded
Masking:
Double (Participant, Investigator)
Masking Description:
In this trial, zoledronic acid or placebo will be administered once immediately before arthroscopic rotator cuff repair. Randomization will take place. immediately before surgery by the anesthesiologist using sealed envelopes. To simplify the study procedure, zoledronic acid 5 mg (Aclasta®), administered as single intravenous infusion (verum) or sodium chloride (physiological saline solution 0.9%), administered as single intravenous infusion (placebo) will be administered preoperatively by the anesthesiologist after induction of anesthesia. Thereby, patients and surgeons are blinded to the randomization process.
Primary Purpose:
Treatment
Official Title:
Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
Actual Study Start Date :
Aug 22, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Zoledronic Acid

zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum

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

Sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml): Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Tendon integrity of the rotator cuff by means of magnetic resonance imaging. [3 years]

    postoperative anatomically regular tendon thickness comparable to an intact tendon.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria

  • 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

  • Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperativel

Exclusion Criteria:

  • 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 ≥ ZORRO Version Draft1.0/09.05.2022 Page 6 of 42 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jakob Schanda Vienna Austria 1120

Sponsors and Collaborators

  • AUVA Traumazentrum Vienna Site UKH Meidling
  • Ludwig Boltzmann Institute for Traumatology _ The research center in cooperation with AUVA
  • CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology

Investigators

  • Principal Investigator: Jakob Schanda, DDr., AUVA Traumazentrum Vienna Site UKH Meidling

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jakob Schanda, Principal Investigator, AUVA Trauma Center Meidling
ClinicalTrials.gov Identifier:
NCT05677152
Other Study ID Numbers:
  • ZORRO
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jakob Schanda, Principal Investigator, AUVA Trauma Center Meidling
zoledronic acid
chronic rotator cuff tears
arthroscopic repair
Additional relevant MeSH terms:
Zoledronic Acid

Study Results

No Results Posted as of Jan 11, 2023