Dupuytren ContractureNCT01876498
Registry of Patient With M. Dupuytren and Validation of the Brief MHQ
An observational study of Dupuytren Contracture and Collagen Shrinkage, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Contracture, Collagen Shrinkage, CRF
- What is being tested?
- Xiaflex surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to Jul 2015
- How long will I take part?
- 1 Year
- 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 M.Dupuytren with Xiapex injection or surgery
Who may be able to join
- M.Dupuytren, over 18y, able to speak and understand german
Who cannot join
- recurrence, pregnancy, incapable of contracting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire
The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register.
Read the detailed description
examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients
- Conditions
- Dupuytren Contracture, Collagen Shrinkage, CRF
- Being tested
- Xiaflex surgery
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaflex surgeryProcedure or surgery
Xiaflex surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient with M. Dupuytren | Xiaflex Surgery Receives: Procedure: Xiaflex surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Michigan Hand Questionnaire
Patient reported outcome measurement by hand disorders
Measured: 6 weeks
Secondary outcomes (1)
Joint mobility
Measuring the joint mobility of the fingers with the goniometer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Herren, Schulthess Klinik
- Investigators
- Daniel Herren, Dr. med., Study chair, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876498
- Sponsor's protocol ID
- Brief MHQ1
- Other IDs
- Dupuytren 1
- Status last verified
- Aug 2016
- First submitted
- 10 Jun 2013
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buildup of a Registry of Patient With M. Dupuytren and Validation of the Brief Michigan Hand Questionnaire
- ClinicalTrials.gov ID
- NCT01876498
- Acronym / sponsor ID
- Brief MHQ1
- Conditions
- Dupuytren Contracture, Collagen Shrinkage, CRF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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 purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register.
Detailed description
examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with M. Dupuytren | – | Procedure: Xiaflex surgeryXiaflex Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with M.Dupuytren with Xiapex injection or surgery
Key inclusion criteria (1 listed)
- M.Dupuytren, over 18y, able to speak and understand german
Key exclusion criteria (1 listed)
- recurrence, pregnancy, incapable of contracting
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 |
|---|---|---|
| Xiaflex surgeryXiaflex surgery | Procedure or surgery | Patient with M. Dupuytren |
Primary outcome
Brief Michigan Hand Questionnaire
Time frame: 6 weeks
Patient reported outcome measurement by hand disorders
1 secondary outcome
Joint mobility
Time frame: 3 years
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 22 Aug 2016.
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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.
Daniel Herren, Dr. med. study chair
Schulthess Klinik
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 Dupuytren Contracture and Collagen Shrinkage, run by Schulthess Klinik 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 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 22 Aug 2016. 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?
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?
Brief Michigan Hand Questionnaire (time frame: 6 weeks). 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 22 Aug 2016.