First CarpoMetacarpal OsteoartrithisNCT04562753
Clinical Trial to Estimate the Efficacy of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
A study testing Maïa® TMC Prosthesis (Lépine Groupe) and APL Suspensionplasty in people with First CarpoMetacarpal Osteoartrithis and Basal Thumb Osteoartrithis, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.
Trial summary
The main objective of the study is to evaluate the efficacy, safety and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis against Suspensionplasty with Abductor Pollicis Longus (APL) for the treatment of patients with first carpometacarpal (CMC) joint osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First CarpoMetacarpal Osteoartrithis, Basal Thumb Osteoartrithis
- What is being tested?
- Maïa® TMC Prosthesis (Lépine Groupe) and APL Suspensionplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 or older.
- Diagnosis of First CMC OA.
- Non-responses to conservative treatment.
- Eaton Stage 2-3
- Physical and cognitive aptitudes to understand and give written informed consent.
Who cannot join
- Comorbidity with other medical conditions which would affect the hand (Carpal Tunnel Syndrome, De Quervain Tenosynovitis, Trigger Finger)
- Rheumatoid Arthritis
- Previous surgery in the same hand.
- Rejection to participate
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Serafin Lirola-Palmero, MD, +34 971205000 ext. 76335, slirola@ssib.es
About this study
Official title: Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
The main objective of the study is to evaluate the efficacy, safety and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis against Suspensionplasty with Abductor Pollicis Longus (APL) for the treatment of patients with first carpometacarpal (CMC) joint osteoarthritis (OA). Patients will be allocated to one of these two groups:
- Maïa® TMC prosthesis (Groupe Lépine TM).
- APL Supensionplasty
We will collect patient data using the questionnaires administeredat baseline and after the treatment. The primary outcome will be pain measured by visual analogue scale (VAS) and secondary outcomes will include health-related quality of life measured by EuroQuol 5D questionnaire,
Read the detailed description
First Carpometacarpal joint osteoarthritis (CMC-OA) is a common problem, being the second location of degenerative osteoarthritis in the hand. The pain, weakness, and swelling cause considerable interference in the activities of daily living, especially in activities that involve repetitive fist-clamp movements.
The conservative treatment available (pain killers, physiotherapy and splints) do not always manage to achieve complete remission of the symptoms or prevent its recurrence. There are several surgical techniques to treat osteoarthritis of the first CMC. The most common surgical treatments used are prosthetic joint replacement and trapeziectomy. The later can be done as an isolated procedure or associated with tendon interposition, ligament reconstruction or both. The preference for indication for one treatment or another is based on personal experience rather than on the available studies, which are highly heterogeneous.
In addition, the direct and indirect costs (those associated with productivity losses as a result of sick leave from the perspective of society) associated with the use of a CMC prosthesis remain unknown, with the shorter recovery time being one of the reasons for its implantation.
The main objective of the study is to determine whether the trapeziometacarpal prosthesis is more effective, safe and cost-effective than suspension suspensionplasty. The secondary objective is to evaluate the functional outcome and estimate the indirect costs and the incremental cost-effectiveness and cost-utility (efficiency) ratios of the trapeziometacarpal prosthesis with respect to suspensionplasty as a treatment for osteoarthritis of the basal thumb joint.
The primary outcome will be measured using the Visual Analogue Scale (VAS). Secondary outcomes will include Quick-DASH and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) and. In addition, we will collect direct and indirect costs.
- Being tested
- Maïa® TMC Prosthesis (Lépine Groupe), APL Suspensionplasty
- Keywords
- CMC Prosthesis, CMC Arthroplasty, Suspensionplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maïa® TMC Prosthesis (Lépine Groupe)Procedure or surgery
Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.
APL SuspensionplastyProcedure or surgery
Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Maïa® TMC Prosthesis (Lépine Groupe) | Active comparator | Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis. Receives: Procedure: Maïa® TMC Prosthesis (Lépine Groupe) |
| APL Suspensionplasty | Active comparator | Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis. Receives: Procedure: APL Suspensionplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain
The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).
Measured: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Secondary outcomes (4)
Health-related quality of life questionnaire Euro-Quol 5D (EQ-5D)
is a standardized instrument for measuring generic health status. It has been widely used in population health surveys, clinical studies, economic evaluation and in routine outcome measurement in the delivery of operational healthcare.
Measured: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
3 Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts
The short form QuickDASH questionnaire will be completed as a reflection of patient-reported specific upper extremity function. Absolute improvement in QuickDASH score will be compared within groups longitudinally and between groups at each time point. QuickDASH scores range from 0 (no disability) to 100 (most severe disability)
Measured: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Change in pre-operative pinch and grip strength as measured by kilograms of pressure.
Power grip using a Jamar (Jackson, MO) dynamometer, followed by lateral (key) and pulp-to-pulp pinch, will be recorded (both in kilograms) with a pinch meter, taking the greater strength of three successive attempts at each position with a 15 second rest between each attempt. The dynamic position of the thumb metacarpophalangeal (MCP) joint will be recorded with a small goniometer during lateral pinch testing (in degrees).
Measured: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Direct and Indirect Costs
To estimate the costs of both interventions from the provider perspective, direct medical costs will be calculated using activity-based cost analysis.
To estimate them from the perspective of society, indirect costs will be added to the direct costs, which will be calculated using the following variables: age, sex, educational level, employment status, profession. It is considered a reasonable measure of labor productivity is the remuneration in the labor market (average earnings or salary).
The utility measure to be used in the cost-utility analysis is the quality-adjusted life years (QALY) as the utility measure. The profits will be obtained through the EQ-5D-5L instrument in its Spanish version and through rates validated for Spain.
Measured: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 May 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First CarpoMetacarpal OsteoartrithisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Collaborators
- Hospital Son Espases
- Responsible party
- Sponsor
- Investigators
- Guillem Salva-Coll, MD, PhD, Study chair, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562753
- Sponsor's protocol ID
- 4144/20
- Status last verified
- Jul 2023
- First submitted
- 19 Aug 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lirola-Palmero S, Salva-Coll G, Yanez-Juan AM, Sanchez-Iriso E. Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial. Trials. 2024 Mar 27;25(1):220. doi: 10.1186/s13063-024-08057-1.
PubMed 38532422
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
- ClinicalTrials.gov ID
- NCT04562753
- Acronym / sponsor ID
- 4144/20
- Keywords
- CMC Prosthesis, CMC Arthroplasty, Suspensionplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Collaborators
- Hospital Son Espases
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Sep 2020 (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 main objective of the study is to evaluate the efficacy, safety and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis against Suspensionplasty with Abductor Pollicis Longus (APL) for the treatment of patients with first carpometacarpal (CMC) joint osteoarthritis (OA). Patients will be allocated to one of these two groups:
- Maïa® TMC prosthesis (Groupe Lépine TM).
- APL Supensionplasty
We will collect patient data using the questionnaires administeredat baseline and after the treatment. The primary outcome will be pain measured by visual analogue scale (VAS) and secondary outcomes will include health-related quality of life measured by EuroQuol 5D questionnaire,
Detailed description
First Carpometacarpal joint osteoarthritis (CMC-OA) is a common problem, being the second location of degenerative osteoarthritis in the hand. The pain, weakness, and swelling cause considerable interference in the activities of daily living, especially in activities that involve repetitive fist-clamp movements.
The conservative treatment available (pain killers, physiotherapy and splints) do not always manage to achieve complete remission of the symptoms or prevent its recurrence. There are several surgical techniques to treat osteoarthritis of the first CMC. The most common surgical treatments used are prosthetic joint replacement and trapeziectomy. The later can be done as an isolated procedure or associated with tendon interposition, ligament reconstruction or both. The preference for indication for one treatment or another is based on personal experience rather than on the available studies, which are highly heterogeneous.
In addition, the direct and indirect costs (those associated with productivity losses as a result of sick leave from the perspective of society) associated with the use of a CMC prosthesis remain unknown, with the shorter recovery time being one of the reasons for its implantation.
The main objective of the study is to determine whether the trapeziometacarpal prosthesis is more effective, safe and cost-effective than suspension suspensionplasty. The secondary objective is to evaluate the functional outcome and estimate the indirect costs and the incremental cost-effectiveness and cost-utility (efficiency) ratios of the trapeziometacarpal prosthesis with respect to suspensionplasty as a treatment for osteoarthritis of the basal thumb joint.
The primary outcome will be measured using the Visual Analogue Scale (VAS). Secondary outcomes will include Quick-DASH and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) and. In addition, we will collect direct and indirect costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maïa® TMC Prosthesis (Lépine Groupe) | Active comparator | Procedure: Maïa® TMC Prosthesis (Lépine Groupe)Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis. |
| APL Suspensionplasty | Active comparator | Procedure: APL SuspensionplastyPatients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18 or older.
- Diagnosis of First CMC OA.
- Non-responses to conservative treatment.
- Eaton Stage 2-3
- Physical and cognitive aptitudes to understand and give written informed consent.
Key exclusion criteria (4 listed)
- Comorbidity with other medical conditions which would affect the hand (Carpal Tunnel Syndrome, De Quervain Tenosynovitis, Trigger Finger)
- Rheumatoid Arthritis
- Previous surgery in the same hand.
- Rejection to participate
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 |
|---|---|---|
| Maïa® TMC Prosthesis (Lépine Groupe)Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis. | Procedure or surgery | Maïa® TMC Prosthesis (Lépine Groupe) |
| APL SuspensionplastyPatients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis. | Procedure or surgery | APL Suspensionplasty |
Primary outcome
Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain
Time frame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).
4 secondary outcomes
Health-related quality of life questionnaire Euro-Quol 5D (EQ-5D)
Time frame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
3 Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts
Time frame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Change in pre-operative pinch and grip strength as measured by kilograms of pressure.
Time frame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Direct and Indirect Costs
Time frame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 38532422Lirola-Palmero S, Salva-Coll G, Yanez-Juan AM, Sanchez-Iriso E. Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial. Trials. 2024 Mar 27;25(1):220. doi: 10.1186/s13063-024-08057-1.
- Individual participant dataSharing planned: No
Related trials for First CarpoMetacarpal Osteoartrithis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
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.
Guillem Salva-Coll, MD, PhD study chair
Hospital Son Espases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maïa® TMC Prosthesis (Lépine Groupe) and APL Suspensionplasty in people with First CarpoMetacarpal Osteoartrithis and Basal Thumb Osteoartrithis, run by Fundació d'investigació Sanitària de les Illes Balears 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 5 inclusion and 4 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 1 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serafin Lirola-Palmero, MD (+34 971 205000 ext. 76335, slirola@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain (time frame: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562753, which also lists 1 linked publication.
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 1 Aug 2023.