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

Hand Tendon Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413031
• Other study ID #: RMB-0110-17
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 30, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Tendon Injury
• Tendon Injuries

Intervention

Device:
• relative motion splint
splint with ability to move the fingers
• static splint
splint with immobility of wrist, and fingers

Locations

Country	Name	City	State
Israel	Rambam medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fingers range of motion	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.	2 months after surgical repair
Primary	Fingers range of motion	Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.	5 months after surgical repair
Primary	Grip strength	Measured with the Jamar Hand Dynamometer	2 months after surgical repair
Primary	Grip strength	Measured with the Jamar Hand Dynamometer	5 months after surgical repair
Primary	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
Primary	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	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
Secondary	Grip strength	Measured with the Jamar Hand Dynamometer	The change between 2 and 5 months after surgical repair
Secondary	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