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

Официальное название

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

Обзор

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.,

Вмешательства

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

Первичные конечные точки

• Tendon integrity of the rotator cuff by means of magnetic resonance imaging. [Срок оценки: 8 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Jakob Schanda — Vienna

Публикации

• Schanda JE, Hackl M, Bischl R, Ullrich R, Boesmueller S, Mittermayr R, Redl H, Grillari J, Fialka C. Intraoperative Zoledronic Acid for Arthroscopic Rotator Cuff Repair Results in Distinct Circulating Micro-RNA Profiles Indicating Improved Tendon-to-Bone Healing. Am J Sports Med. 2026 Jun 18:3635465261455031. doi: 10.1177/03635465261455031. Online ahead of print. PMID 42316896
• Schanda JE, Ullrich R, Boesmueller S, Mittermayr R, Bruell T, Hexel M, Heuberer PR, Woisetschlaeger G, Neuper OM, Redl H, Grillari J, Fialka C. Intraoperative Zoledronic Acid for Arthroscopic Rotator Cuff Repair: Short-Term Results From a Prospective, Randomized, Placebo-Controlled Phase II Trial. Am J Sports Med. 2026 Feb;54(2):342-352. doi: 10.1177/03635465251399167. Epub 2026 Jan 18. PMID 41549490

Идентификаторы

NCT: NCT05677152 · ZORRO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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