跳至主要内容
临床试验/NCT06836349
NCT06836349招募中不适用

Registry-randomized Comparison of Rehabilitation Regimens After Flexor Pollicis Longus Injury in the Thumb

Karolinska Institutet5 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
380
试验地点
5
主要终点
Tendon rupture rate

研究概览

简要总结

Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery.

The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons.

The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization).

This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and
  • •Age over 15 years. Minors (<18 years) are considered to have sufficient maturity to understand the implications of the research.
  • •Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury.

排除标准

  • •Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues.
  • •Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.

研究组 & 干预措施

Early active motion

Active Comparator

Early active motion 2-5 days postoperatively.

干预措施: Early active motion training after operated FPL injury (Other)

Immobilisation in plaster cast 4 weeks

Active Comparator

Immobilisation in plaster cast 4 weeks postoperatively

干预措施: Immobilisation in plaster cast 4 weeks after operated FPL injury (Other)

结局指标

主要结局

Tendon rupture rate

时间窗: Within one year after operation

Clinically diagnosed rupture of an operated flexor pollicis longus injury

次要结局

  • Quick DASH(3 and 12 months postoperatively)
  • HQ-8 questionnaire(3 and 12 months postoperatively)
  • Active range of motion in the joints of the operated thumb MCP joint(3 and 12 months postoperatively)
  • Active range of motion of the IP-joint in the opererated thumb(3 and 12 months postoperatively)
  • Grip strength(3 and 12 months postoperatively)
  • Key pinch strength(3 and 12 months postoperatively)
  • Overall satisfaction with rehabilitation(3 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Wilcke

Associate professor

Karolinska Institutet

研究点 (5)

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