Flexor Tendon RuptureNCT05078476
Rehabilitation of Finger Flexor Tendon Injuries
A study testing Manchester Short Splint and Relative Motion Flexion in people with Flexor Tendon Rupture, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Tendon Rupture
- What is being tested?
- Manchester Short Splint and Relative Motion Flexion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2021to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature
- ≥ 18 years old
- Understanding of the German language (written and oral)
- Single and multiple finger injuries
- Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
- Treated by the hand surgery department at the Inselspital Bern
- Treated with at least a 4-strand core suture
Who cannot join
- < 18 years old
- Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
- Replantation of the injured finger
- Fracture of the injured finger
- Primary tendon reconstructions
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Tamara Hauri, 0041316328319, tamara.hauri@extern.insel.ch
About this study
Official title: Early Active Motion in the Rehabilitation of Flexor Tendon Injuries: Short Splint Versus Relative Motion: a Pilot Randomized Controlled Trial
The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.
- Conditions
- Flexor Tendon Rupture
- Being tested
- Manchester Short Splint, Relative Motion Flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manchester Short SplintOther
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
Relative Motion FlexionOther
3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
| Study group | Role | What they receive |
|---|---|---|
| Manchester Short Splint | Active comparator | Dorsal splint ending shortly behind the wrist. The splint will be worn for 6 weeks after surgery and the patient will perform active and passive exercises in the splint. Receives: Other: Manchester Short Splint |
| Relative Motion Flexion | Experimental | In the relative motion splint the injured finger is positioned in relative flexion in the MCP joint to the adjacent fingers. Additionally to the relative motion flexion splint a wrist orthosis is adapted. Passive and active exercises will be performed out of the splint. Receives: Other: Relative Motion Flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient satisfaction
The satisfaction with the outcome will be evaluated by asking the patient a Single Assessment Numeric Evaluation (SANE) question: "How satisfied are you with your hand on a scale from 0 (not satisfied at all) to 10 (fully satisfied)?
Measured: 13 and 26 weeks after tendon repair
Secondary outcomes (11)
Michigan Hand Questionnaire (MHQ)
The MHQ is a hand specific questionnaire used to measure the ability in daily function. The total score ranges from 0 to 100, with higher scores indicating better performance.
Measured: 6, 13 and 26 weeks after tendon repair
Disabilities of Shoulder, Arm and Hand Questionnaire
The DASH questionnaire is a region-specific outcome instrument. The patient will rate 30-items about disability or symptoms by rating the degree of difficulty in doing various activities. The scores of all items are used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).
Measured: 6, 13 and 26 weeks after tendon repair
Range of motion
The range of motion will be measured with a goniometry.
Measured: 6, 13 and 26 weeks after tendon repair
Grip Strength
Grip Strength will be measured with the JAMAR Dynamometer.
Measured: 13 and 26 weeks after tendon repair
Level of pain
The patient will be asked to rate the pain from 0 to 10. 0 indicates no pain, 10 the worst possible pain. The patient rate the pain while relaxed and during exercises.
Measured: 6, 13 and 26 weeks after tendon repair
Number of therapy sessions
The number of therapy sessions will be counted after 26 weeks or at the end of of therapy if after 26 weeks measurement.
Measured: 26 weeks after tendon repair
Ten Test
The Ten Test is a measure of discriminative sensation, whereby the patient describes the sensation from no sensation "0" to normal sensation "10" on an 11-point Likert scale.
Measured: 6, 13 and 26 weeks after tendon repair
Patients specific function scale
The patient defines three to five activities that are difficult or that he/she is unable to perform due to the hand injury. The patient is asked to rate the difficulty associated with each activity from 0 to 10. 0 is defined as not able to do the activity and 10 is able to do the activity normally.
Measured: 6, 13 and 26 weeks after tendon repair
Work Productivity and Activity Impairment Questionnaire
The WPAI is a quantitative assessment of absenteeism, presenteeism, and overall productivity loss attributable to a specific health problem during the previous 7 days.
Measured: 6, 13 and 26 weeks after tendon repair
Rupture rate/ Complications
Tendon rupture will be documented
Measured: 26 weeks after tendon repair
Complications
complications will be documented (e.g. CRPS, infection)
Measured: 26 weeks after tendon repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Dec 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Flexor Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Tobler, Dr. phil., Principal investigator, Inselspital, Bern Universtiy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078476
- Sponsor's protocol ID
- 2021-00929
- Status last verified
- Jun 2023
- First submitted
- 13 Oct 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Active Motion in the Rehabilitation of Flexor Tendon Injuries: Short Splint Versus Relative Motion: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05078476
- Acronym / sponsor ID
- 2021-00929
- Conditions
- Flexor Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Oct 2021 (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.
The primary objective is to compare the two different rehabilitation protocols relative motion flexion and short splint regarding patients'satisfaction in patients with flexor tendon injuries in Zone I and II after 13 and 26 weeks post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manchester Short Splint | Active comparator | Other: Manchester Short SplintDorsal splint ending shortly behind the wrist. The splint will be worn for 6 weeks after surgery and the patient will perform active and passive exercises in the splint. |
| Relative Motion Flexion | Experimental | Other: Relative Motion FlexionIn the relative motion splint the injured finger is positioned in relative flexion in the MCP joint to the adjacent fingers. Additionally to the relative motion flexion splint a wrist orthosis is adapted. Passive and active exercises will be performed out of the splint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent as documented by signature
- ≥ 18 years old
- Understanding of the German language (written and oral)
- Single and multiple finger injuries
- Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
Key exclusion criteria (5 listed)
- < 18 years old
- Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
- Replantation of the injured finger
- Fracture of the injured finger
- Primary tendon reconstructions
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 |
|---|---|---|
| Manchester Short Splint3-5 days after tendon repair the patient will start with hand therapy and the described protocol. | Other | Manchester Short Splint |
| Relative Motion Flexion3-5 days after tendon repair the patient will start with hand therapy and the described protocol. | Other | Relative Motion Flexion |
Primary outcome
Change in patient satisfaction
Time frame: 13 and 26 weeks after tendon repair
The satisfaction with the outcome will be evaluated by asking the patient a Single Assessment Numeric Evaluation (SANE) question: "How satisfied are you with your hand on a scale from 0 (not satisfied at all) to 10 (fully satisfied)?
11 secondary outcomes
Michigan Hand Questionnaire (MHQ)
Time frame: 6, 13 and 26 weeks after tendon repair
Disabilities of Shoulder, Arm and Hand Questionnaire
Time frame: 6, 13 and 26 weeks after tendon repair
Range of motion
Time frame: 6, 13 and 26 weeks after tendon repair
Grip Strength
Time frame: 13 and 26 weeks after tendon repair
Level of pain
Time frame: 6, 13 and 26 weeks after tendon repair
Number of therapy sessions
Time frame: 26 weeks after tendon repair
Ten Test
Time frame: 6, 13 and 26 weeks after tendon repair
Patients specific function scale
Time frame: 6, 13 and 26 weeks after tendon repair
Work Productivity and Activity Impairment Questionnaire
Time frame: 6, 13 and 26 weeks after tendon repair
Rupture rate/ Complications
Time frame: 26 weeks after tendon repair
Complications
Time frame: 26 weeks after tendon repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- 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.
Bernadette Tobler, Dr. phil. principal investigator
Inselspital, Bern Universtiy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manchester Short Splint and Relative Motion Flexion in people with Flexor Tendon Rupture, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamara Hauri (0041316328319, tamara.hauri@extern.insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient satisfaction (time frame: 13 and 26 weeks after tendon repair). 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 NCT05078476, 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 9 Jun 2023.