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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hand Tendon Injury

Intervention / Treatment
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* Device: relative motion splint
* Device: static splint


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: relative motion splint<br> | Device: relative motion splint<br>* splint with ability to move the fingers<br>|
| Active Comparator: static splint<br> | Device: static splint<br>* splint with immobility of wrist, and fingers<br>|

What is the study measuring?
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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 |