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

Fundacin Biomedica Galicia Sur

Status: Completed

Conditions: Hand Injuries; Tendon Injuries

Treatments: Device: ICAMS Splinting Protocol; Device: Classic Plaster Immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT06950268

2020/307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older
• Patients from the CHUVI Health Area
• Diagnosed with an acute, single, complete extensor tendon laceration in zones IV, V, or VI of the long fingers
• Treated with primary tenorrhaphy
• Provided signed informed consent
• Agreed to attend follow-up visits and comply with the study protocol

Exclusion criteria

• More than one extensor tendon laceration in the same hand
• Injuries involving the thumb
• Tendon injuries with loss of substance
• Associated injuries at the same level (e.g., bone fracture, nerve lesion)
• Patients with cognitive impairment or inability to follow the protocol
• Presence of other injuries or medical conditions that could interfere with assessment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

ICAMS Group

Experimental group

Description:

Participants received immediate controlled active motion splinting (ICAMS) after extensor tendon tenorrhaphy. The ICAMS protocol included a daytime yoke splint, which maintained the injured finger in 20° more extension than adjacent fingers, and a nocturnal intrinsic plus static splint. The protocol was maintained for 4 weeks post-surgery

Treatment:

Device: ICAMS Splinting Protocol

Classic Immobilization Group

Active Comparator group

Description:

Participants received standard immobilization with a plaster splint in the intrinsic plus position following extensor tendon tenorrhaphy. The immobilization was maintained continuously for 4 weeks.

Treatment:

Device: Classic Plaster Immobilization