NCT06950268

Randomized Trial of Active vs Passive Splinting for Extensor Tendon Injuries in Zones IV to VI

A Randomized Controlled Trial Comparing Active and Passive Motion Splint Immobilization for the Treatment of Extensor Tendon Injuries in Zones IV to VI of the Hand

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fundacin Biomedica Galicia Sur · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares two methods of post-operative immobilization after surgical repair (tenorrhaphy) of extensor tendons in the fingers. Patients were randomly assigned to receive either a standard plaster splint or an alternative splinting method that allows controlled finger movement (ICAMS). The main goal was to determine which method leads to better recovery in terms of finger mobility, grip strength, pain, and patient comfort.

Detailed description

Extensor tendon injuries of the hand are commonly treated with immobilization for 4-6 weeks using a plaster splint in the intrinsic plus position. However, prolonged immobilization may lead to tendon adhesions, joint stiffness, and delayed return to function. This randomized controlled clinical trial evaluated the efficacy of an immediate controlled active motion splinting protocol (ICAMS) compared to classic immobilization (CI) following extensor tendon tenorrhaphy in zones IV, V, and VI. Thirty patients were randomly assigned to either group. Functional outcomes were assessed at 4 and 6 weeks post-injury, including grip strength, joint range of motion, pain (VAS), Quick-DASH score, and patient satisfaction. The ICAMS group showed significantly better results in all main functional parameters. These findings support the use of early active motion protocols in selected cases of extensor tendon injury to enhance recovery and patient comfort.

Conditions

• Hand Injuries
• Tendon Injuries

Interventions

Type	Name	Description
DEVICE	ICAMS Splinting Protocol	The ICAMS protocol consisted of a daytime yoke splint maintaining the injured finger in 20° more extension than adjacent fingers, combined with a nocturnal static splint in the intrinsic plus position. The splinting was applied for 4 weeks following extensor tendon tenorrhaphy.
DEVICE	Classic Plaster Immobilization	Participants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-08-25
• Completion: 2021-08-30
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: Spain