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

Not Applicable

Completed

• Conditions: Hand Tendon Injury
• Interventions: Device: relative motion splint; Device: static splint

• Registration Number: NCT05413031
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Primary Completion: 2021-02-27
• Study Completion: 2021-03-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
relative motion splint	relative motion splint	-
static splint	static splint	-

Primary Outcome Measures

Name	Time	Method
Grip strength	5 months after surgical repair	Measured with the Jamar Hand Dynamometer
Fingers range of motion	5 months after surgical repair	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	5 months after surgical repair	The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Fingers range of motion	The change between 2 and 5 months after surgical repair	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Grip strength	The change between 2 and 5 months after surgical repair	Measured with the Jamar Hand Dynamometer
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	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.

Trial Locations

Locations (1)

Rambam medical center; 🇮🇱 Haifa, Israel