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

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

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.

Study Overview

• Status: Completed
• Conditions: Hand Tendon Injury
• Intervention / Treatment: Device: relative motion splint; Device: static splint

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: relative motion splint	Device: relative motion splint; splint with ability to move the fingers
ACTIVE_COMPARATOR: static splint	Device: static splint; splint with immobility of wrist, and fingers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fingers range of motion	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.	2 months after surgical repair
Fingers range of motion	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.	5 months after surgical repair
Grip strength	Measured with the Jamar Hand Dynamometer	2 months after surgical repair
Grip strength	Measured with the Jamar Hand Dynamometer	5 months after surgical repair
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.	2 months after surgical repair
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.	5 months after surgical repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fingers range of motion	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.	The change between 2 and 5 months after surgical repair
Grip strength	Measured with the Jamar Hand Dynamometer	The change between 2 and 5 months after surgical repair
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.	The change between 2 and 5 months after surgical repair

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2018
• Primary Completion (ACTUAL): February 27, 2021
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (ACTUAL): June 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: RMB-0110-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No