Back to resultsComparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair
Primary Purpose
Hand Tendon Injury
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
relative motion splint
static splint
Sponsored by
About this trial
This is an interventional treatment trial for Hand Tendon Injury
Eligibility Criteria
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.
Sites / Locations
- Rambam medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
relative motion splint
static splint
Arm Description
Outcomes
Primary Outcome Measures
Fingers range of motion
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Fingers range of motion
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Grip strength
Measured with the Jamar Hand Dynamometer
Grip strength
Measured with the Jamar Hand Dynamometer
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 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.
Secondary Outcome Measures
Fingers range of motion
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Grip strength
Measured with the Jamar Hand Dynamometer
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05413031
Brief Title
Comparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair
Official Title
Treatment of Finger Extensor Tendon Rupture - Comparison Between Static and Relative Motion Splints
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
February 27, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Tendon Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
relative motion splint
Arm Type
Active Comparator
Arm Title
static splint
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
relative motion splint
Intervention Description
splint with ability to move the fingers
Intervention Type
Device
Intervention Name(s)
static splint
Intervention Description
splint with immobility of wrist, and fingers
Primary Outcome Measure Information:
Title
Fingers range of motion
Description
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Time Frame
2 months after surgical repair
Title
Fingers range of motion
Description
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Time Frame
5 months after surgical repair
Title
Grip strength
Description
Measured with the Jamar Hand Dynamometer
Time Frame
2 months after surgical repair
Title
Grip strength
Description
Measured with the Jamar Hand Dynamometer
Time Frame
5 months after surgical repair
Title
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Description
The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.
Time Frame
2 months after surgical repair
Title
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Description
The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.
Time Frame
5 months after surgical repair
Secondary Outcome Measure Information:
Title
Fingers range of motion
Description
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Time Frame
The change between 2 and 5 months after surgical repair
Title
Grip strength
Description
Measured with the Jamar Hand Dynamometer
Time Frame
The change between 2 and 5 months after surgical repair
Title
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Description
The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.
Time Frame
The change between 2 and 5 months after surgical repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rambam medical center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair
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