Influence Of Zoledronic Acid On Healing After Arthroskopic Repair Of Chronic Rotator Cuff Lesions A Prospective, Randomized, Placebo-Controlled Phase II Trial ZORRO
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Tendon integrity 6 months postoperative (no re-rupture/re-rupture) Tendon integrity 12, 24 and 60 months postoperative (no re-rupture/re-rupture)
研究概览
简要总结
Longitudinal investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six, twelve, twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions. Null hypothesis: Adjuvant intravenous therapy with zoledronic acid does not improve tendon healing after arthroscopic reconstruction of chronic rotator cuff tears compared to a control group without adjuvant therapy with zoledronic acid.
详细描述
Several aspects of the incidence will be assessed (number of zolpidem consumers, change in consumption profile, and consumption of other sedative drugs) before and after the regulatory framework change.
The epidemiological study will enable us to respond to all these aspects and it will be completed by the observational study with practitioners and patients that have been affected by the regulatory framework change.
General practitioners will be interviewed by phone about their perception of the regulatory framework change, their attitudes towards their patients with zolpidem prescription and the drugs they used if they had changed the patients prescription.
All consumers included in the study will have to fulfill a self-questionnaire about their perception of the regulatory framework change, their attitudes towards their consumption of zolpidem (stop, diminution, replacement) and their favorite replacement drug.
The impact of regulatory prescription change of zolpidem will have a pleiotropic impact which can't be evaluated on a single criterion. It must be considered in a global, multifocal manner. This is why several criteria will be used to assess several incidence and several populations.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- • Age between 50 and 70 years Magnetic resonance imaging verified rotator cuff tear (within 6 months 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 postoperatively
排除标准
- • 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 ≥ 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
结局指标
主要结局
Tendon integrity 6 months postoperative (no re-rupture/re-rupture) Tendon integrity 12, 24 and 60 months postoperative (no re-rupture/re-rupture)
Tendon integrity 6 months postoperative (no re-rupture/re-rupture) Tendon integrity 12, 24 and 60 months postoperative (no re-rupture/re-rupture)
次要结局
- Fatty muscle infiltration, shoulder abduction and adduction, shoulder anteversion and retroversion, shoulder rotation internal and external, shoulder strength, pain evaluation, Constant-Murley-Score, American Shoulder and Elbow Surgeons Score, Subjective Shoulder Value
研究者
DDr. Jakob Schanda
Scientific
AUVA Trauma Center Vienna