Arthroscopic Scaphoid Bone Graft Combined With Percutaneous Fixation Versus Open Scaphoid Fixation With Non Vascularized Graft in Scaphoid Non-union
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- union rate
研究概览
简要总结
the investigators compare the arthroscopic grafting technique with the traditional open technique in th treatment of scaphoid non union as regards the union rate, time to union and functional outcomes to provide the best intervention to the patient
详细描述
The treatment of scaphoid non union has no gold standard technique so in this study the investigators try to compare the arthroscopic and the open grafting techniques to determine the better technique to achieve union, time to union and the better functional outcomes including wrist range of motion and grip strength as a primary outcome and the secondary outcomes are the operative time, the complications and radiological correction of the hum-back deformity if present.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scaphoid non-union cases
- •16 years or older
- •males or females
- •independent from chronicity or non-union location and the investigators defined the non union as failure to reach scaphoid union up to 6 months
排除标准
- •.Revision scaphoid non-union cases.
- •Previously operated wrist for any other pathology
- •Avascular necrosis (AVN) confirmed by intraoperative inspection.
- •Scaphoid non-union advanced collapse (SNAC) stage 2 and higher.
- •Any associated wrist pathology that required separate treatment surgical approach.
结局指标
主要结局
union rate
时间窗: 6 months
percentage of patients in each arm that achieve bony union
time to union
时间窗: 6 to 24 weeks
the time that patient take to achieve bony union
wrist flexion and extension
时间窗: preoperative, at 6 months and at 24 months
flexion and extension range of motion
wrist radial and ulnar deviation
时间窗: preoperative, at 6 months and at 24 months
radial and ulnar deviation range of motion
grip strength
时间窗: preoperative , at 6 months and at 24 months
the power of hand grip measured by dynamometer
The disability of arm, shoulder and hand score (DASH score)
时间窗: preoperative , at 6 months and at 24 months
a questionnaire to assess upper limb function from 0 to 100 where the lower the score means better outcome
The Mayo modified wrist score
时间窗: preoperative, at 6 months and at 24 months
A functional score that depends on the patients function and examination from 0 to 100 and the higher the score the higher the outcome
次要结局
- complications(2 years post operative)
- Degree of scaphoid hump back deformity correction(post operative after bony union up to 1 year)
- Operative time(intraoperative)