NCT00408291已完成不适用
Evaluation of the Winsta PH Osteosynthesis Device in the Treatment of Three- and Four-Part Fractures of the Proximal Humerus A Prospective Migration and Bone Density Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
研究概览
简要总结
The purpose of this study is to study with the use of clinical and radiological parameters the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device (Fischer Medical).
详细描述
We shall measure the following 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
We shall measure the following radiologic parameters:
- Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
- Plate migration with use of MB-RSA
- Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
- Correlation between bone density and prosthesis migration (and tuberculum migration)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with three-part and four-part proximal humeral fractures
- •Aged 50 years or older and fit
- •Informed, written consent
- •A functioning shoulder preoperatively -
排除标准
- •Patients found unsuitable preoperatively for a shoulder Philos Plate
- •Patients aged 85 or older
- •Patients with rheumatoid arthritis
- •Patients who previously had undergone shoulder plastic or other major shoulder surgery
- •Patients unable to avoid NSAID after surgery
- •Patients requiring regular systemic steroid treatment
- •Female patients taking hormone substitution
- •Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
- •Patients with metabolic bone disease -
结局指标
主要结局
Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
时间窗: five years
Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
次要结局
- Muscle strength(five years)
- Activities of Daily Living (ADL)(five years)
- Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)(five years)
- Range of Motion (ROM)(five years)
- Correlation between bone density and prosthesis migration (and tuberculum migration)(five years)
研究者
研究点 (1)
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