Early Functional Return to Work Following Distal Biceps Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Time (days) to return to work on modified duties
研究概览
简要总结
Distal biceps ruptures occur most commonly among young males in their third and fourth decade of life. These injuries are becoming more common, however, as the aging population is remaining active through sport or labour demands. Distal biceps tears or ruptures follow a heavy eccentric load being placed on a shortened or flexed muscle, and often require surgical repair. Functionally, distal biceps injuries cause impairment as this portion of the muscle is largely responsible for supination and flexion at the elbow. Currently there is no consensus regarding post-operative immobilization protocols, and little evidence is available regarding timeframe for early return to functional activities. Existing evidence on functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small sample sizes, and no known RCTs exist comparing early mobilization to immobilization on functional return. Reported timeframes for immobilization range from early controlled motion on day 1 post-operatively to complete immobilization for 6 weeks.
The primary study goal is to determine the effect of immobilization compared to unrestricted mobility post DBTR on early functional return to activities. It has been previously reported that those with DBTR related to a workers compensation injury returned to full duties in 3.95 months, while those with a non-workers compensation related injury returned to full work duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013 and 2014. Early mobilization of these repairs may allow an earlier return to modified and full work duties, thereby improving the functional quality of life of the individual as well as reducing the overall cost of disability payments.
This study will assess the 1) time to return to pre-injury work level and 2) time to return to modified duties among those who have no movement restriction post-repair and those who are splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will strength, range of motion (ROM) and quality of life. These findings will assist in developing a standardized protocol for immobilization to optimize functional and clinical outcomes while expediting return to work.
详细描述
Research Questions:
In patients who are immobilized for 6 weeks and those who are allowed unrestricted movement following DBTR, Are there differences during the first post-operative year in:
- Time to return to work (modified and pre-injury levels)?
- The proportion of subjects (if any) who re-rupture
a. Strength (flexion, supination) of the elbow b. ROM (flexion, supination) of the elbow c. Self-reported functional quality of life d. Pain between groups
Research Hypotheses:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male subjects between 18 and 65 years of age
- •patient has had a DBTR amenable to surgical repair
- •surgeon must be able to obtain a tension-free repair using an endobutton.
- •participants must have been working prior to the injury
- •patient must be expected to return to work post-injury
排除标准
- •outside of the specified age range
- •patient with an identified congenital abnormality at the insertion of the distal biceps tendon
- •those who have previously ruptured the tendon or those with tendon ruptures resulting from a multi-trauma
- •patients with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent
- •patients with life expectancy of less than 2 years
- •patients who do not speak/read/understand English
- •patients with no fixed address or contact information
- •patients who are unwilling to complete follow-ups
结局指标
主要结局
Time (days) to return to work on modified duties
时间窗: 1 year
Self reported
次要结局
- Time (days) to return to pre-injury level of work(12 months)
- Re-rupture rate(12 months)
