Flexor Tendon RuptureNCT05093946
Psychometric Measurement Properties of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair
An observational study of Flexor Tendon Rupture, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Tendon Rupture
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2021to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients with flexor tendon injuries in Zone I-V for in the fingers and/or thumb.
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
About this study
Official title: Psychometric Measurement Properties of the German Version of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair
The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.
- Conditions
- Flexor Tendon Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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, 13 1/2 and 26 weeks after tendon repair
Secondary outcomes (1)
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). The DASH 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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 University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093946
- Sponsor's protocol ID
- 2021-00929a
- 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
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
- Psychometric Measurement Properties of the German Version of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT05093946
- Acronym / sponsor ID
- 2021-00929a
- Conditions
- Flexor Tendon Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 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
- 26 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 aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with flexor tendon injuries in Zone I-V for in the fingers and/or thumb.
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.
Primary outcome
Change in Michigan Hand Questionnaire (MHQ)
Time frame: 6, 13, 13 1/2 and 26 weeks after tendon repair
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.
1 secondary outcome
Disabilities of Shoulder, Arm and Hand Questionnaire
Time frame: 6, 13 and 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.
- 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 University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 (00413116328319, 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 Michigan Hand Questionnaire (MHQ) (time frame: 6, 13, 13 1/2 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?
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.