Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Migration of resurfacing prostheses
研究概览
简要总结
The purpose of this study is to determine whether there is a difference between the result of treatment of shoulder osteoarthritis with two different shoulder prostheses.
详细描述
In this randomized study, we wish to investigate with the use of clinical and radiological parameters whether there is a difference between the result of treatment of shoulder osteoarthritis with the Copeland resurfacing prosthesis and the Global CAP resurfacing prosthesis.
Clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):
- Pain
- Activities of Daily Living (ADL)
- Range of Motion (ROM)
- Muscle strength
Radiologic parameters:
- Migration of resurfacing prostheses with use of MB-RSA
- Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA)
- Correlation between bone density and prosthesis migration
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
- •Aged 18 years or older and fit
- •Informed, written consent -
排除标准
- •Patients found unsuitable preoperatively for a resurfacing prosthesis
- •Patients aged 85 or older
- •Patients with rheumatoid arthritis
- •Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
- •Patients unable to avoid NSAID after surgery
- •Patients requiring regular systemic steroid treatment
- •Female patients taking hormone substitution
- •Patients with metabolic bone disease
- •Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery)
- •Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -
研究组 & 干预措施
2
The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
干预措施: Copeland or Global CAP resurfacing prosthesis (Procedure)
1
The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
干预措施: Copeland or Global CAP resurfacing prosthesis (Procedure)
结局指标
主要结局
Migration of resurfacing prostheses
时间窗: five years
Bone density around the prosthesis
时间窗: five years
Pain
时间窗: five years
Activities of Daily Living (ADL)
时间窗: five years
次要结局
- Correlation between bone density and prosthesis migration(five years)
- Range of Motion (ROM)(five years)
- Muscle strength(five years)