NCT05062252招募中不适用
Multicentric, Prospective, Comparative Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Oxford Shoulder Score
研究概览
简要总结
The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 yr
- •Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
- •Willingness and ability to comply with study protocol
排除标准
- •Medical condition or balance impairment that could lead to falls
- •Prior rotator cuff surgery
- •Cuff tear arthropathy/insufficient rotator cuff
- •Insufficient bone quality which may affect the stability of the implant
- •Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
- •Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
- •Active metastatic or neoplastic disease at the shoulder joint
- •Chemotherapy treatment/radiotherapy within 6 mo before surgery
- •>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
- •Pregnancy or plan to become pregnant during study period
- •Inability to understand study or a history of noncompliance with medical advice
- •Alcohol or drug abuse
- •Current enrollment in any clinical research study that might interfere with this study
- •Metal allergies or sensitivity.
- •Previous or current infection at or near the site of implantation.
- •Current distant or systemic infection
- •Patient, whose infomed consent form should be taken in an emergency situation
- •ONLY for women of childbearing age: a positive pregnancy test (urine / blood)
结局指标
主要结局
Oxford Shoulder Score
时间窗: 12 months
0 (worst) - 48 (best)
次要结局
- Device Success Rate(24 months)
- Constant score(24 months)
- Subjective Shoulder Value(24 months)
- Device parameters(24 months)
- Oxford Shoulder Score(24 months)
研究者
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
不适用
Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.Shoulder ProsthesisNCT04431973University Hospital, Tours100
进行中（未招募）
不适用
Clinical and Radiological Outcomes of Medacta Shoulder SystemPrimary OsteoarthritisSecondary OsteoarthritisRotator Cuff Tear ArthropathyRheumatoid Arthritis ShoulderAvascular NecrosisRevision of Shoulder ArthroplastyFractureNCT03547947Medacta International SA200
招募中
不适用
Clinical and Radiological Outcomes of Medacta Shoulder System FRPrimary OsteoarthritisSecondary OsteoarthritisRotator Cuff Tear ArthropathyRheumatoid Arthritis ShoulderRevision of Shoulder ArthroplastyFractureAvascular NecrosisNCT05926622Medacta International SA200
已完成
不适用
Effects of Mirror Therapy Combined With Progressive Strength Training in Unilateral Spastic Cerebral PalsySpastic Hemiplegic Cerebral PalsyNCT02458612Hacettepe University30
进行中（未招募）
不适用
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)Primary OsteoarthritisSecondary OsteoarthritisRotator Cuff Tear ArthropathyRheumatoid Arthritis ShoulderRevision of Shoulder ArthroplastyAvascular NecrosisFractureNCT05002335Medacta International SA200