RhizarthrosisNCT05047744
Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
A study testing Touch Dual Mobility CMC I Prosthesis in people with Rhizarthrosis, run by Kepler University Hospital at 1 site in Austria.
Trial summary
The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Touch Dual Mobility CMC I Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 15 Sep 2019to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CMC I Osteoarthritis /Stage III)
Who cannot join
- CMC I (osteoarthritis / Other Stage than III)
- Anticoagulation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Kepler Universitaetsklinikum GmbH
Linz, 4020
Stefan M Froschauer, MD, +4373278061020, stefan.froschauer@kepleruniklinikum.at
About this study
The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).
Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.
Read the detailed description
The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).
Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.
The Study is designed to give clinical results after one year, 2 years and also long time results in the future.
- Conditions
- Rhizarthrosis
- Being tested
- Touch Dual Mobility CMC I Prosthesis
- Keywords
- CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch Dual Mobility CMC I ProsthesisDevice
Surgery
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis Cohort | Experimental | Surgery dual mobility Prosthesis Receives: Device: Touch Dual Mobility CMC I Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH Score (Disability of Arm Shoulder and Hand Score)
DASH Score is taken before Surgery and after 6, 12 and 24 months DASH (Disabilty of Arm Shoulder and Hand) Score reaches from 0-100, whereas 0 reprensents best score while 100 represents worst
Measured: 24 months
Secondary outcomes (1)
Subjective Pain
patients report about subjective Pain level in average at 6, 12 and 24 months in a VAS (Visual Analog Pain Scale) scale (0-10), whereas 0 is best and 10 worst
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start15 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047744
- Sponsor's protocol ID
- KUK-UNF-21-001
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT05047744
- Acronym / sponsor ID
- KUK-UNF-21-001
- Conditions
- Rhizarthrosis
- Keywords
- CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Sep 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 dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).
Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.
Detailed description
The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).
Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.
The Study is designed to give clinical results after one year, 2 years and also long time results in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Prosthesis Cohort | Experimental | Device: Touch Dual Mobility CMC I ProsthesisSurgery dual mobility Prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- CMC I Osteoarthritis /Stage III)
Key exclusion criteria (2 listed)
- CMC I (osteoarthritis / Other Stage than III)
- Anticoagulation
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 |
|---|---|---|
| Touch Dual Mobility CMC I ProsthesisSurgery | Device | Prosthesis Cohort |
Primary outcome
DASH Score (Disability of Arm Shoulder and Hand Score)
Time frame: 24 months
DASH Score is taken before Surgery and after 6, 12 and 24 months DASH (Disabilty of Arm Shoulder and Hand) Score reaches from 0-100, whereas 0 reprensents best score while 100 represents worst
1 secondary outcome
Subjective Pain
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch Dual Mobility CMC I Prosthesis in people with Rhizarthrosis, run by Kepler University Hospital at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 22 Aug 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 Austria. 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 Stefan M Froschauer, MD (004373278061020, stefan.froschauer@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH Score (Disability of Arm Shoulder and Hand Score) (time frame: 24 months). 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 2022.