NCT05413031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

June 2, 2022

Last Update Submit

June 9, 2022

Conditions

Hand Tendon Injury

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

relative motion splint

ACTIVE COMPARATOR
Device: relative motion splint

static splint

ACTIVE COMPARATOR
Device: static splint

Interventions

relative motion splintDEVICE

splint with ability to move the fingers

relative motion splint
static splintDEVICE

splint with immobility of wrist, and fingers

static splint

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form.

You may not qualify if:

  • patients that did not arrive for a follow-up meeting after 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical center

Haifa, Israel

Location

Related Publications (1)

  • Hardy M, Feehan L, Savvides G, Wong J. How controlled motion alters the biophysical properties of musculoskeletal tissue architecture. J Hand Ther. 2023 Apr-Jun;36(2):269-279. doi: 10.1016/j.jht.2022.12.003. Epub 2023 Apr 5.

    PMID: 37029054DERIVED

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 9, 2022

Study Start

January 30, 2018

Primary Completion

February 27, 2021

Study Completion

March 30, 2021

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)