Clinical trial NCT06950268: Randomized Trial of Active vs Passive Splinting for Extensor Tendon Injuries in Zones IV to VI
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Injuries
Tendon Injuries
Keywords: Classic Immobilization
Hand Surgery
Postoperative Rehabilitation
Extensor Tendon Repair
ICAMS
Finger Tendon
Zones IV to VI
Controlled Motion Splint
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind, parallel-group design comparing ICAMS versus classic immobilization following extensor tendon tenorrhaphy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Grip Strength of the Injured Hand
timeFrame: 4 and 6 weeks after injury
Secondary outcomes:
measure: Change in MCP Joint Flexion
timeFrame: 4 and 6 weeks after injury
measure: Pain Intensity (VAS Score)
timeFrame: 4 and 6 weeks after injury
measure: Quick-DASH Score
timeFrame: 4 and 6 weeks after injury
measure: Patient Comfort With Immobilization
timeFrame: 4 and 6 weeks after injury
measure: Patient Satisfaction With Treatment Outcome
timeFrame: 4 and 6 weeks after injury
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: CHUVI Hospital (Complejo Hospitalario Universitario de Vigo)
state: Pontevedra
Study officials:
affiliation: Sergas
name: Miguel Cela-López, MD
role: PRINCIPAL_INVESTIGATOR
References: