Influence of Zoledronic Acid on Healing After Arthroscopic Repair of Chronic Rotator Cuff Lesions - A Prospective, Randomized, Placebo-controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
研究概览
简要总结
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.,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
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 ≥ 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)
- •Claustrophobia
- •Chronic alcohol abuse
- •Drug abuse
研究组 & 干预措施
Zoledronic Acid
zoledronic acid 5 mg (Aclasta®) administered as single intravenous infusion (100 ml): Verum
干预措施: Intravenous Infusion of Aclasta® (Drug)
physiological saline solution 0.9%
Sodium chloride (physiological saline solution 0.9%) administered as single intravenous infusion (100 ml): Placebo
干预措施: Intravenous Infusion of Aclasta® (Drug)
结局指标
主要结局
Tendon integrity of the rotator cuff by means of magnetic resonance imaging.
时间窗: 8 years
postoperative anatomically regular tendon thickness comparable to an intact tendon.
次要结局
未报告次要终点
研究者
Jakob Schanda
Principal Investigator
AUVA Trauma Center Meidling