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临床试验/NCT03850210
NCT03850210已完成不适用

The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs

Manchester University NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months

研究概览

简要总结

The project sets out to compare two different splints in the outcome of zone II flexor tendon injury hand therapy rehabilitation programme. Traditional hand therapy is based on using a long forearm-based splint for 6 weeks in zone II flexor tendon injuries. Manchester University NHS Foundation Trust have devised a new shorter splint to use as an alternative to the traditional longer splint as there are cogent reasons for believing that permitting more wrist movement during rehabilitation will improve the range of finger movement ultimately (tendonesis effects).

Patients will be randomised to receive either the traditional long splint, or the short splint. Patients will be followed up and data will be collected at routine hand therapy appointments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

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

入选标准

  • Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit

排除标准

  • Adult patients lacking capacity or motivation to participate in the planned physiotherapy
  • Adult patients with special needs and vulnerable groups
  • Adult patients who undergo surgical repair of their flexor tendon more than 4 days after the initial injury
  • Patients unable to understand English adequately
  • Adult patients unable to attend the hospital facility for the requisite number of planned physiotherapy sessions (social reasons)
  • Adult patients with multiple level injuries
  • Injuries with soft tissue loss requiring coverage
  • Adult patients with two nerve injuries on the same finger
  • Adult patients with multiple digit flexor tendon injury
  • Adult patients with concomitant bony injury to the hand
  • Children under 16 years age

结局指标

主要结局

Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months

时间窗: Active and passive motion ranges to be recorded at 3 and 6 months

Range of motion of the proximal interphalangeal joint of the injured digit as measured by hand therapist using goniometer (angle measuring device)

次要结局

  • Rupture of repaired flexor tendon(Monitored at 3 and 6 months)
  • Tendon adhesions needing tenolysis(Monitored at 3 and 6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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