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Completed

NCT Number: NCT05413031

Comparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair

Different splints are used after hand extensor tendon repair (including relative motion splint, static splint, etc.) There is no consensus regarding the benefits of either one.

The aim of this study is to compare clinical outcomes after using different orthoses and rehabilitation methods after hand extensor tendon repair.

Patients are randomly assigned after signing consent to either immobilization with a static splint or a relative motion splint. Patients are examined after 2 and 5 months postoperatively for finger range of motion, grip strength, and DASH questionnaire.

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Key information

Conditions

Hand Tendon Injury

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam medical center

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form.

Exclusion criteria

  • patients that did not arrive for a follow-up meeting after 2 months.

Treatment and study plan

relative motion splint

Device

splint with ability to move the fingers

static splint

Device

splint with immobility of wrist, and fingers

Primary outcomes

  1. Fingers range of motion

    Time frame: 2 months after surgical repair

    Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.

  2. Fingers range of motion

    Time frame: 5 months after surgical repair

    Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.

  3. Grip strength

    Time frame: 2 months after surgical repair

    Measured with the Jamar Hand Dynamometer

  4. Grip strength

    Time frame: 5 months after surgical repair

    Measured with the Jamar Hand Dynamometer

  5. The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

    Time frame: 2 months after surgical repair

    The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

  6. The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

    Time frame: 5 months after surgical repair

    The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

Secondary outcomes

  1. Fingers range of motion

    Time frame: The change between 2 and 5 months after surgical repair

    Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.

  2. Grip strength

    Time frame: The change between 2 and 5 months after surgical repair

    Measured with the Jamar Hand Dynamometer

  3. The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

    Time frame: The change between 2 and 5 months after surgical repair

    The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Treatment of Finger Extensor Tendon Rupture - Comparison Between Static and Relative Motion Splints

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2022
Registry last updated
Jun 13, 2022

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.

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