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NCT Number: NCT05677152

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

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.,

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Key information

Conditions

Orthopedics Traumatology

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Infusion of Aclasta®

Drug

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

Primary outcomes

  1. Tendon integrity of the rotator cuff by means of magnetic resonance imaging.

    Time frame: 8 years

    postoperative anatomically regular tendon thickness comparable to an intact tendon.

Study contacts

Contact information is provided by the study sponsor or research team.

Jakob Schanda, DDr.

CONTACT

[email protected]

+435939345201

Ortrun Neuper, MSc.

CONTACT

[email protected]

+436764543334

Sponsors and collaborators

Lead sponsor

AUVA Traumazentrum Vienna Site UKH Meidling

Other

Collaborators

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

Registry information

Official study title

Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial

Acronym: ZORRO

Important dates

Study start
2022
Primary completion
2025
Study completion
2030
First posted
Jan 10, 2023
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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