RizarthrosisNCT07101887
Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis, Focusing on Changes in Pain (Measured With the VAS Scale) and Function (With the Quick-DASH).
A study testing Implantation of thumb prosthesis and Burton-Pellegrini technique in people with Rizarthrosis, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rizarthrosis
- What is being tested?
- Implantation of thumb prosthesis and Burton-Pellegrini technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 1 Nov 2025
- Phase
- Interventional
- 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
Who may be able to join
- Rizarthrosis grade I, II, III
Who cannot join
- Rizarthrosis grade IV
- Severe osteoporosis
- Metals allergy
- Previous surgical interventions related
- Malformations in the articular zones that difficult the implant placement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.
It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).
- Conditions
- Rizarthrosis
- Being tested
- Implantation of thumb prosthesis, Burton-Pellegrini technique
- Keywords
- Thumb, osteoarthritis, prosthesis, trapeziectomy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of thumb prosthesisProcedure or surgery
Replacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis.
Burton-Pellegrini techniqueProcedure or surgery
Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon
| Study group | Role | What they receive |
|---|---|---|
| Maia Prosthesis group | Experimental | Not described Receives: Procedure: Implantation of thumb prosthesis |
| Trapeziectomy and Burton-Pellegrini technique | Experimental | Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon Receives: Procedure: Burton-Pellegrini technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Pain evaluated by Visual analogic scale (VAS)
Measured: 1 year
Quick Dash
Function of the arm evaluated by Quick Dash scale
Measured: 1 year
Secondary outcomes (1)
Strength
Strength evaluated with a pressure gauge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jun 2022
- Primary completion30 Jun 2025
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RizarthrosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101887
- Sponsor's protocol ID
- 2019/8942/I
- Status last verified
- Feb 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.
- ClinicalTrials.gov ID
- NCT07101887
- Acronym / sponsor ID
- 2019/8942/I
- Conditions
- Rizarthrosis
- Keywords
- Thumb, osteoarthritis, prosthesis, trapeziectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 3 Aug 2025 (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.
It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maia Prosthesis group | Experimental | Procedure: Implantation of thumb prosthesis |
| Trapeziectomy and Burton-Pellegrini technique | Experimental | Procedure: Burton-Pellegrini techniqueRemove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Rizarthrosis grade I, II, III
Key exclusion criteria (5 listed)
- Rizarthrosis grade IV
- Severe osteoporosis
- Metals allergy
- Previous surgical interventions related
- Malformations in the articular zones that difficult the implant placement
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 |
|---|---|---|
| Implantation of thumb prosthesisReplacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis. | Procedure or surgery | Maia Prosthesis group |
| Burton-Pellegrini techniqueRemove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon | Procedure or surgery | Trapeziectomy and Burton-Pellegrini technique |
Primary outcome
VAS
Time frame: 1 year
Pain evaluated by Visual analogic scale (VAS)
Quick Dash
Time frame: 1 year
Function of the arm evaluated by Quick Dash scale
1 secondary outcome
Strength
Time frame: 1 year
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 3 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of thumb prosthesis and Burton-Pellegrini technique in people with Rizarthrosis, run by Parc de Salut Mar at 1 site in Spain.
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 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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 Spain. 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 Daniel Valverde Vilamala (+34 626330598, dvalverde@hmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 1 year). The study lists 2 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 3 Aug 2025.