Complications Due to Internal Joint ProsthesisNCT03611023
Study of the Touch® Trapezo-metacarpal Prosthesis
An observational study of Complications Due to Internal Joint Prosthesis and Thumb Osteoarthritis, run by Groupe Concepteur Touch at 1 site in France.
Trial summary
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complications Due to Internal Joint Prosthesis, Thumb Osteoarthritis
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to Sep 2036
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with the Touch® prosthesis by one of the three investigating surgeons
Who may be able to join
- Patients implanted with the Touch® prosthesis by one of the three investigating surgeons
Who cannot join
- Patient not in capacity to understand the study
- Patient not in capacity to consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis
Read the detailed description
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival at 3 years
Failure rate of the implant
Measured: 3 Years
Implant Survival at 5 years
Failure rate of the implant
Measured: 5 Years
Implant Survival at 10 years
Failure rate of the implant
Measured: 10 Years
Implant Survival at 15 years
Failure rate of the implant
Measured: 15 Years
Secondary outcomes (4)
Functional Outcome at 3 years
QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Measured: 3 Years
Functional Outcome at 5 years
QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Measured: 5 Years
Functional Outcome at 10 years
QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Measured: 10 Years
Functional Outcome at 15 years
QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Oct 2018
- Primary completionSep 2036 (estimated)
- Study completionSep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications Due to Internal Joint ProsthesisStudies 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
- 350 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Groupe Concepteur Touch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Cyril Falaise, Groupe Concepteur Touch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611023
- Sponsor's protocol ID
- 2018-01
- Status last verified
- Nov 2019
- First submitted
- 9 Jul 2018
- Last updated
- 29 Nov 2019
- 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis
- ClinicalTrials.gov ID
- NCT03611023
- Acronym / sponsor ID
- 2018-01
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Groupe Concepteur TouchUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Sep 2036 (estimated)
- Study completion
- Sep 2036 (estimated)
- First posted
- 2 Aug 2018 (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.
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis
Detailed description
Prospective observational study of implanted patients with a new orthopaedic implant: the Touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with the Touch® prosthesis by one of the three investigating surgeons
Key inclusion criteria (1 listed)
- Patients implanted with the Touch® prosthesis by one of the three investigating surgeons
Key exclusion criteria (2 listed)
- Patient not in capacity to understand the study
- Patient not in capacity to consent to the study
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
Implant Survival at 3 years
Time frame: 3 Years
Failure rate of the implant
Implant Survival at 5 years
Time frame: 5 Years
Failure rate of the implant
Implant Survival at 10 years
Time frame: 10 Years
Failure rate of the implant
Implant Survival at 15 years
Time frame: 15 Years
Failure rate of the implant
4 secondary outcomes
Functional Outcome at 3 years
Time frame: 3 Years
Functional Outcome at 5 years
Time frame: 5 Years
Functional Outcome at 10 years
Time frame: 10 Years
Functional Outcome at 15 years
Time frame: 15 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: No
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?
An observational study of Complications Due to Internal Joint Prosthesis and Thumb Osteoarthritis, run by Groupe Concepteur Touch at 1 site in France.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2019. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Implant Survival at 3 years (time frame: 3 Years). The study lists 4 primary outcomes in all. 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 29 Nov 2019.