Effectiveness of Intensive Rehabilitation on Shoulder Function After a Fracture of the Proximal Humerus Treated by Locked Plate. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Functional outcome on Constant score
研究概览
简要总结
The fracture of the proximal humerus represents 4% of the fractures encountered in clinics and it must be treated surgically. Thus, the aim of the surgical treatment is to maintain bone alignment, articular congruity, vascularization of the humeral head and provide a painless shoulder with satisfactory function.
The objective of this study is to demonstrate the potential benefits of an early rehabilitation program on shoulder function.
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
- 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
- •Male or female over 18 years
- •Unstable fracture of the proximal humerus
- •Two-part and three-part fractures according to the Neer classification
- •Closed fracture
- •Time between trauma and surgery less than or equal to 7 days
- •Signing of consent form
排除标准
- •Stable fracture of the proximal humerus (not requiring surgery)
- •Four-part fracture on the Neer classification
- •Fracture-dislocation or fracture involving the articular surface
- •Isolated fracture of the large or small tuberosity
- •Pathological fracture
- •Fracture associated with neuro-vascular lesions
- •Bilateral fractures
- •Fracture associated with long bones fracture
- •Polytrauma
- •Previous history of fracture or surgery to the ipsilateral proximal humerus
- •Severe COPD
- •Severe neuromuscular disorders (Parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ...)
- •Remote location of patient's home which makes it difficult to come to facility for follow-up visits
- •Any medical condition making it impossible for the patient to perform the exercise program (Alzheimer, dementia, etc. ...)
- •Man or woman incapacitated sign consent form
- •Any other condition which prevents the assessor from fully monitoring the patient during study.
结局指标
主要结局
Functional outcome on Constant score
时间窗: 6 months after surgery
The investigators will validate that early and intensive rehabilitation gives a better functional outcome at 6 months using the Constant score adjusted for age. A difference of 10 points is considered significant (standard deviation of 15 points).
次要结局
- Proportion of reoperation(within the first year following surgery)
- Loss of radiological reduction(12 months after surgery)
- Sustainability of the efficacy on Constant score(12 months after surgery)
- Quality of life on DASH scale(12 months after surgery)
- Return to professional activities(3 or 4 months after surgery)
- Pain on visual analog scale (VAS)(10-14 days after surgery)
- Pain on VAS(12 months after surgery)
- Measurement of range of motion of shoulder(12 months after surgery)
研究者
Pelet Stephane
Dr Stephane Pelet MD, PhD Orthopedic surgeon
Hopital de l'Enfant-Jesus