Hand Tendon InjuryNCT05413031
Comparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair
A study testing relative motion splint and static splint in people with Hand Tendon Injury, run by Rambam Health Care Campus at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hand Tendon Injury
- What is being tested?
- relative motion splint and static splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jan 2018to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form.
Who cannot join
- patients that did not arrive for a follow-up meeting after 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Finger Extensor Tendon Rupture - Comparison Between Static and Relative Motion Splints
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.
- Conditions
- Hand Tendon Injury
- Being tested
- relative motion splint, static splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relative motion splintDevice
splint with ability to move the fingers
static splintDevice
splint with immobility of wrist, and fingers
| Study group | Role | What they receive |
|---|---|---|
| relative motion splint | Active comparator | Not described Receives: Device: relative motion splint |
| static splint | Active comparator | Not described Receives: Device: static splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fingers range of motion
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Measured: 2 months after surgical repair
Fingers range of motion
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Measured: 5 months after surgical repair
Grip strength
Measured with the Jamar Hand Dynamometer
Measured: 2 months after surgical repair
Grip strength
Measured with the Jamar Hand Dynamometer
Measured: 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.
Measured: 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.
Measured: 5 months after surgical repair
Secondary outcomes (3)
Fingers range of motion
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
Measured: The change between 2 and 5 months after surgical repair
Grip strength
Measured with the Jamar Hand Dynamometer
Measured: 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.
Measured: The change between 2 and 5 months after surgical repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 Jan 2018
- Primary completion27 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand Tendon InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413031
- Sponsor's protocol ID
- RMB-0110-17
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37029054
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Finger Extensor Tendon Rupture - Comparison Between Static and Relative Motion Splints
- ClinicalTrials.gov ID
- NCT05413031
- Acronym / sponsor ID
- RMB-0110-17
- Conditions
- Hand Tendon Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| relative motion splint | Active comparator | Device: relative motion splint |
| static splint | Active comparator | Device: static splint |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form.
Key exclusion criteria (1 listed)
- patients that did not arrive for a follow-up meeting after 2 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relative motion splintsplint with ability to move the fingers | Device | relative motion splint |
| static splintsplint with immobility of wrist, and fingers | Device | static splint |
Primary outcome
Fingers range of motion
Time frame: 2 months after surgical repair
Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.
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: 2 months after surgical repair
Measured with the Jamar Hand Dynamometer
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: 2 months after surgical repair
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
Time frame: 5 months after surgical repair
The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.
3 secondary outcomes
Fingers range of motion
Time frame: The change between 2 and 5 months after surgical repair
Grip strength
Time frame: The change between 2 and 5 months after surgical repair
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: The change between 2 and 5 months after surgical repair
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 37029054Hardy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relative motion splint and static splint in people with Hand Tendon Injury, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fingers range of motion (time frame: 2 months after surgical repair). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.