RhizarthrosisTRAPEzENCT06078189
Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy
An observational study of Rhizarthrosis, run by Clinique Bizet at 1 site in France.
Trial summary
Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- HORUS
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2023to Dec 2028
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic disabling osteoarthritis in failure of medical treatment
Who may be able to join
- Age >45 years
- Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
- Patient who has given his/her consent to participate in the study after being informed by the surgeon,
- Patient living in France and able to answer the survey alone.
- Subject affiliated to a social security system or beneficiary of such a system
- No participation in any other clinical study
Who cannot join
- Minor patient
- Trapezium height < 8 mm
- Major subject protected by law, under curatorship or guardianship
- Known allergy to the materials of the medical device
- Local infection
- Local skin necrosis or unhealed wound
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique BIZET
Paris, 75116
Bouchra BENKESSOU, MP, 0764486016
Camille ECHALIER, DR
About this study
Official title: Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation
Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.
The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.
Read the detailed description
This is a two-center, randomized, prospective, comparative study.
The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.
The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.
- Conditions
- Rhizarthrosis
- Being tested
- HORUS
- Keywords
- osteoarthritis - Trapezectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HORUSDevice
The trapezium-metacarpal arthroplasty consists of the installation of a bipolar prosthesis composed of a metacarpal implant and a trapezial implant articulated through a metacarpal "head".
| Study group | Role | What they receive |
|---|---|---|
| Control | Trapezectomy group | |
| Experimental | Arthroplasty group Receives: Device: HORUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient assessment of the wrist
Quick-Dash score (11 minimum value and 55 is maximum
)
Measured: 4 weeks
Secondary outcomes (1)
patient assessment of the wrist pain
Visual Analogical Assessment score (0 no pain 10 severe pain)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start24 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078189
- Sponsor's protocol ID
- 2022-A02775-38
- Acronym
- TRAPEzE
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation
- ClinicalTrials.gov ID
- NCT06078189
- Acronym / sponsor ID
- TRAPEzE / 2022-A02775-38
- Conditions
- Rhizarthrosis
- Keywords
- osteoarthritis - Trapezectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Oct 2023 (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.
Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.
The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.
Detailed description
This is a two-center, randomized, prospective, comparative study.
The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.
The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Trapezectomy group |
| Experimental | – | Device: HORUSArthroplasty group |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic disabling osteoarthritis in failure of medical treatment
Key inclusion criteria (6 listed)
- Age >45 years
- Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
- Patient who has given his/her consent to participate in the study after being informed by the surgeon,
- Patient living in France and able to answer the survey alone.
- Subject affiliated to a social security system or beneficiary of such a system
Key exclusion criteria (7 listed)
- Minor patient
- Trapezium height < 8 mm
- Major subject protected by law, under curatorship or guardianship
- Known allergy to the materials of the medical device
- Local infection
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 |
|---|---|---|
| HORUSThe trapezium-metacarpal arthroplasty consists of the installation of a bipolar prosthesis composed of a metacarpal implant and a trapezial implant articulated through a metacarpal "head". | Device | Experimental |
Primary outcome
patient assessment of the wrist
Time frame: 4 weeks
Quick-Dash score (11 minimum value and 55 is maximum )
1 secondary outcome
patient assessment of the wrist pain
Time frame: 4 weeks
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 10 Sep 2026.
Related trials for Rhizarthrosis
RecruitingPhase 2
Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
Rhizarthrosis
Active, not recruitingPhase 4
Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb
Rhizarthrosis
Recruiting
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
Trapeziometacarpal Osteoarthritis, Rhizarthrosis
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.
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 Rhizarthrosis, run by Clinique Bizet 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
Contact Bouchra BENKESSOU, PM (0764486016, b.benkessou@hexagone-santé-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient assessment of the wrist (time frame: 4 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 10 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.