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Clinical Trials/NCT05413031
NCT05413031CompletedNot Applicable

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

Rambam Health Care Campus1 site in 1 country26 target enrollmentStarted: January 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Fingers range of motion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

relative motion splint

Active Comparator

Intervention: relative motion splint (Device)

static splint

Active Comparator

Intervention: static splint (Device)

Outcomes

Primary Outcomes

Fingers range of motion

Time Frame: 5 months after surgical repair

Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.

Grip strength

Time Frame: 5 months after surgical repair

Measured with the Jamar Hand Dynamometer

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

Time Frame: 5 months after surgical repair

The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

Grip strength

Time Frame: 2 months after surgical repair

Measured with the Jamar Hand Dynamometer

Fingers range of motion

Time Frame: 2 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

Time Frame: 2 months after surgical repair

The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

Secondary Outcomes

  • Fingers range of motion(The change between 2 and 5 months after surgical repair)
  • Grip strength(The change between 2 and 5 months after surgical repair)
  • The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire(The change between 2 and 5 months after surgical repair)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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