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

NCT ID: NCT06950268

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ICAMS Group

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

Group Type: EXPERIMENTAL

ICAMS Splinting Protocol

Intervention Type: DEVICE

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.

Classic Immobilization Group

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.

Group Type: ACTIVE_COMPARATOR

Classic Plaster Immobilization

Intervention Type: DEVICE

Participants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy.

Interventions

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.

Intervention Type: DEVICE

Classic Plaster Immobilization

Participants received a classic plaster splint in the intrinsic plus position worn continuously for 4 weeks following extensor tendon tenorrhaphy.

Intervention Type: DEVICE

Other Intervention Names

Immediate Controlled Active Motion Splinting; Dynamic Splint; Yoke Splint; Intrinsic Plus Position Splint; Standard Immobilization

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Cela-López, MD

Role: PRINCIPAL_INVESTIGATOR

Sergas

Locations

CHUVI Hospital (Complejo Hospitalario Universitario de Vigo)

Vigo, Pontevedra, Spain

Countries

Spain

Other Identifiers

2020/307

Identifier Type: -

Identifier Source: org_study_id