A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fixation to bone as measured with radiostereometric analysis (RSA)
研究概览
简要总结
The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary osteoarthritis of the shoulder
- •Age 40-75 years
- •Patient capable of giving informed consent
- •Patient agrees to comply with the study plan
排除标准
- •Destruction of the proximal humerus
- •Insufficient bone stock
- •Deficient rotator cuff or earlier failed surgery of the rotator cuff
- •Large muscle defects or insufficient blood supply in the affected arm
- •Neuromuscular disorders
- •Infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study
- •Patient unwilling to comply with study regulations
- •Patient with earlier allergic reaction to pyrocarbon
- •Patient with known metastatic disease
- •Patient who has been treated with more than 10 mg corticosteroids (e.g. Prednisone) daily within 3 months from surgery.
- •Patient participating in other clinical study
- •Patient in need of glenoid replacement
研究组 & 干预措施
Pyrocarbon
Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)
干预措施: PyroTITAN, Ascension Orthopedics, Inc. (Device)
Pyrocarbon
Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)
干预措施: TITAN, Ascension Orthopedics, Inc. (Device)
CoCr
Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)
干预措施: PyroTITAN, Ascension Orthopedics, Inc. (Device)
CoCr
Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)
干预措施: TITAN, Ascension Orthopedics, Inc. (Device)
结局指标
主要结局
Fixation to bone as measured with radiostereometric analysis (RSA)
时间窗: 24 months
Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.
次要结局
- Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS)(24-48 months)
研究者
Olof Skoldenberg
Director of research, Orthopedic dept.
Danderyd Hospital