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

NCT06950268 | Completed

• 1 other identifier: 2020/307
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Grip Strength of the Injured Hand

  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.

  4 and 6 weeks after injury

Secondary Outcomes (5)

• Change in MCP Joint Flexion

  4 and 6 weeks after injury

• Pain Intensity (VAS Score)

  4 and 6 weeks after injury

• Quick-DASH Score

  4 and 6 weeks after injury

• Patient Comfort With Immobilization

  4 and 6 weeks after injury

• Patient Satisfaction With Treatment Outcome

  4 and 6 weeks after injury

Study Arms (2)

ICAMS Group

EXPERIMENTAL

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

Device: ICAMS Splinting Protocol

Classic Immobilization Group

ACTIVE COMPARATOR

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.

Device: Classic Plaster Immobilization

Interventions

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.

Also known as: Immediate Controlled Active Motion Splinting, Dynamic Splint, Yoke Splint

ICAMS Group

Classic Plaster Immobilization DEVICE

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

Also known as: Intrinsic Plus Position Splint, Standard Immobilization

Classic Immobilization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

CHUVI Hospital (Complejo Hospitalario Universitario de Vigo)

Vigo, Pontevedra, 36312, Spain

Location

MeSH Terms

Conditions

Hand Injuries; Tendon Injuries

Interventions

Splints

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Miguel Cela-López, MD

  Sergas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind study. The outcomes assessor was blinded to group allocation. Participants and care providers were not blinded due to the visible nature of the splints.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, parallel-group design comparing ICAMS versus classic immobilization following extensor tendon tenorrhaphy

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: July 1, 2020
• Primary Completion: August 25, 2021
• Study Completion: August 30, 2021
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)