Clinical trial NCT05677152: Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Official title: Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Orthopedics
Traumatology
Keywords: zoledronic acid
chronic rotator cuff tears
arthroscopic repair
Lead sponsor: AUVA Traumazentrum Vienna Site UKH Meidling
Sponsor class: OTHER
Collaborators: name: Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
name: CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology
First posted: 2023-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo controlled trial (Zoledronic acid versus Placebo), randomized,

2 Teams: unblinded and blinded
Primary purpose: TREATMENT

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.,


Eligibility criteria: 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

Primary outcomes:
measure: Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Jakob Schanda
Study officials:
affiliation: AUVA Traumazentrum Vienna Site UKH Meidling
name: Jakob Schanda, DDr.
role: PRINCIPAL_INVESTIGATOR
References: