Skip to main content
OpenTrials
Completed

NCT Number: NCT06950268

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hand Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUVI Hospital (Complejo Hospitalario Universitario de Vigo)

Vigo, Pontevedra, 36312, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICAMS Splinting Protocol

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.

Other names: Immediate Controlled Active Motion Splinting, Dynamic Splint, Yoke Splint

Classic Plaster Immobilization

Device

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

Other names: Intrinsic Plus Position Splint, Standard Immobilization

Primary outcomes

  1. Change in Grip Strength of the Injured Hand

    Time frame: 4 and 6 weeks after injury

    Grip strength was measured using a JAMAR manual dynamometer to evaluate functional recovery after extensor tendon tenorrhaphy. Measurements were taken at 4 and 6 weeks post-injury.

Secondary outcomes

  1. Change in MCP Joint Flexion

    Time frame: 4 and 6 weeks after injury

    Active flexion of the metacarpophalangeal (MCP) joints of the injured finger was measured to assess recovery of joint mobility.

  2. Pain Intensity (VAS Score)

    Time frame: 4 and 6 weeks after injury

    Pain was evaluated using a 10-point Visual Analog Scale (VAS) at both follow-up visits.

  3. Quick-DASH Score

    Time frame: 4 and 6 weeks after injury

    Upper limb disability and function were assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.

  4. Patient Comfort With Immobilization

    Time frame: 4 and 6 weeks after injury

    Patients rated their comfort with the splint using a yes/no response at 4 weeks post-treatment.

  5. Patient Satisfaction With Treatment Outcome

    Time frame: 4 and 6 weeks after injury

    Patients reported overall satisfaction with the treatment using a yes/no response.

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.