Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Wrist Range of Motion (ROM)
研究概览
简要总结
The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction
- •Isolated upper limb injury
- •No previous wrist fracture
- •Available for follow-up
- •Between 60 and 100 years of age
排除标准
- •Less than 60 years of age
- •Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.
研究组 & 干预措施
Generic plaster or fiberglass cast group
Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
干预措施: Cast made of generic plaster or fiberglass cast material (Device)
Generic "off the shelf" removable splint group
Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.
干预措施: Generic "off the shelf" removable splint (Device)
结局指标
主要结局
Change in Wrist Range of Motion (ROM)
时间窗: Baseline, Month 3
Wrist ROM will be assessed by a goniometer exam.
Mean Mayo Wrist Score
时间窗: Baseline, Week 2, Week 6, Week 12
The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.
Change in Grip Strength
时间窗: Baseline, Month 3
Grip strength will be assessed by bilateral dynamometer testing.
Complication Rate
时间窗: Duration of Study (Up to 3 Months)
The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.
Mean Pain Score
时间窗: Baseline, Week 2, Week 6, Week 12
Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable". The assessment was completed at all study visits.
次要结局
- Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score(Baseline, Week 2, Week 6, Week 12)
- Change in SF-12 QOL(Baseline, Month 3)
研究者
Claudius Jarrett
Assistant Professor of Orthopaedics
Emory University