Osteoarthritis in the Carpometacarpal (CMC) JointNCT07583628
CMC-1 Replacement Arthroplasty Versus Trapeziectomy
An observational study of Osteoarthritis in the Carpometacarpal (CMC) Joint, run by Karolinska Institutet.
Trial summary
Thumb carpometacarpal (CMC-1) osteoarthritis is a common condition causing pain and disability, particularly among middle-aged and older women. When non-operative treatment fails, surgery is indicated. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis in the Carpometacarpal (CMC) Joint
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients are adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.
Who may be able to join
- adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.
Who cannot join
- Bilateral CMC-1 surgery or other simultaneous hand interventions
- Previous CMC-1 surgery on the affected hand
- Inflammatory joint disease affecting the hands (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- 30% missing baseline (preoperative) variables
About this study
Thumb carpometacarpal (CMC-1) osteoarthritis is a common condition causing pain and disability, particularly among middle-aged and older women. When non-operative treatment fails, surgery is indicated. In Sweden, trapeziectomy (TE), with or without tendon-based adjuncts, is the standard procedure and recommended in the National Care Program introduced in 2022. However, total joint arthroplasty (TJA) has gained popularity because of reports of faster recovery and improved early function, although concerns remain regarding complications, durability, and cost. Comparative studies are therefore needed.
The aim of this study is to compare patient-reported outcomes after dual-mobility TJA versus TE, with or without tendon-based adjuncts, for CMC-1 osteoarthritis using data from the Swedish Hand Surgery Quality Register (HAKIR). To reduce bias in observational data, the study will emulate a hypothetical randomized target trial.
Read more
This registry-based cohort study will include adults aged 45 years or older undergoing primary surgery for CMC-1 osteoarthritis. Patients with previous CMC-1 surgery, bilateral procedures, inflammatory joint disease, or extensive missing baseline data will be excluded. Baseline is defined as the date of surgery, and patients will be followed using patient-reported outcome measures collected preoperatively and at 3 and 12 months.
The primary outcome is change in pain on load measured with the HQ-8 questionnaire at 12 months. Secondary outcomes include pain at 3 months, low pain levels at 12 months, other HQ-8 domains, QuickDASH score, patient satisfaction, grip and pinch strength, thumb range of motion, time to reoperation, and postoperative complications.
Potential confounders will be identified using a directed acyclic graph (DAG). Measured confounders include age, sex, surgical centre, calendar year, baseline pain, baseline function, and smoking. Unmeasured factors such as surgeon preference, patient preference, and disease severity not captured in the registry may still cause residual confounding.
Primary analyses will use linear mixed-effects regression to compare adjusted mean pain outcomes between groups at 12 months while accounting for clustering by patient and centre. Secondary outcomes will be analysed using ordinal logistic regression, Cox proportional hazards regression, and logistic regression. Missing data will be handled using multiple imputation, and sensitivity analyses using inverse probability weighting will assess the impact of reoperations and selection bias
- Keywords
- thumb base, osteoarthritis, PROM, trapeziectomy, joint replacement, CMC-1
- Medical subject headings
- Capillary Malformations, Congenital, 1, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults diagnosed with and operated for CMC1 OA (ICD-10 M18*) | 1. Trapeziectomy (TE) with or without tendon adjunct according to routine practice with Flexor Carpi Radialis/Extensor Carpi Radialis Longus/Abductor Pollicis Longus/Palmaris Longus). 2. Total joint thumb base dual mobility arthroplastyDual mobility TJA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire.
Pain on load motion assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
Measured: Baseline and 12 months postoperatively
Secondary outcomes (12)
Change from baseline to 12 months in pain on unloaded motion measured with the HAKIR questionnaire
Pain on unloaded motion assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
Measured: Baseline and 12 months after surgery
Change from baseline to 12 months in pain at rest measured with the HQ-8 questionnaire
Pain at rest assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
Measured: Baseline and 12 months postoperatively
Change from baseline to 12 months in stiffness measured with the HQ-8 questionnaire
Stiffness assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
Measured: Baseline and 12 months postoperatively
Change from baseline to 12 months in weakness measured with the HQ-8 questionnaire
Weakness assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
Measured: Baseline and 12 months postoperatively
Change from baseline to 12 months in activities of daily living measured with the HQ-8 questionnaire
Activities of daily living assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
Measured: Baseline and 12 months postoperatively
Change from baseline to 12 months in Quick Disabilities of Arm, Shoulder and Hand Questionnaire (Quick DASH)
Upper extremity disability and symptoms assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 to 100, where higher scores indicate greater disability and worse upper extremity function.
Measured: Baseline and 12 months postoperatively
Change in key pinch strength
kg
Measured: Baseline and 12 months postoperatively
Change in grip strength
jamar (kg)
Measured: Baseline and 12 months postoperatively
Change in thumb radial abduction
radial abduction (degrees)
Measured: Baseline and 12 months postoperatively
Change in thumb plamar abduction
palmar abduction (degrees)
Measured: From preoperatively to 12 months postoperatively
Time to first reoperation* of the index hand
Measured: primary horizon: 12 months; secondary: maximum available follow-up
Risk of any (non-reoperation) complication within 12 months
occurrence of any registered postoperative complication of the index hand recorded in HAKIR
Measured: within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jan 2011
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis in the Carpometacarpal (CMC) JointStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Maria Wilcke, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583628
- Sponsor's protocol ID
- HAKIRcmc1
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data generated and analyzed during this study are stored within HAKIR and are subject to Swedish data protection legislation and the GDPR. Due to legal and ethical restrictions, individual-level participant data cannot be made publicly available. Access to de-identified study data may be granted to qualified researchers upon reasonable request and subject to approval by the Swedish Ethical Review Authority and the HAKIR steering committee. Access to the statistical code will be granted after reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMC-1 Replacement Arthroplasty Versus Trapeziectomy
- ClinicalTrials.gov ID
- NCT07583628
- Acronym / sponsor ID
- HAKIRcmc1
- Keywords
- thumb base, osteoarthritis, PROM, trapeziectomy, joint replacement, CMC-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 May 2026 (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.
Thumb carpometacarpal (CMC-1) osteoarthritis is a common condition causing pain and disability, particularly among middle-aged and older women. When non-operative treatment fails, surgery is indicated. In Sweden, trapeziectomy (TE), with or without tendon-based adjuncts, is the standard procedure and recommended in the National Care Program introduced in 2022. However, total joint arthroplasty (TJA) has gained popularity because of reports of faster recovery and improved early function, although concerns remain regarding complications, durability, and cost. Comparative studies are therefore needed.
The aim of this study is to compare patient-reported outcomes after dual-mobility TJA versus TE, with or without tendon-based adjuncts, for CMC-1 osteoarthritis using data from the Swedish Hand Surgery Quality Register (HAKIR). To reduce bias in observational data, the study will emulate a hypothetical randomized target trial.
This registry-based cohort study will include adults aged 45 years or older undergoing primary surgery for CMC-1 osteoarthritis. Patients with previous CMC-1 surgery, bilateral procedures, inflammatory joint disease, or extensive missing baseline data will be excluded. Baseline is defined as the date of surgery, and patients will be followed using patient-reported outcome measures collected preoperatively and at 3 and 12 months.
The primary outcome is change in pain on load measured with the HQ-8 questionnaire at 12 months. Secondary outcomes include pain at 3 months, low pain levels at 12 months, other HQ-8 domains, QuickDASH score, patient satisfaction, grip and pinch strength, thumb range of motion, time to reoperation, and postoperative complications.
Potential confounders will be identified using a directed acyclic graph (DAG). Measured confounders include age, sex, surgical centre, calendar year, baseline pain, baseline function, and smoking. Unmeasured factors such as surgeon preference, patient preference, and disease severity not captured in the registry may still cause residual confounding.
Primary analyses will use linear mixed-effects regression to compare adjusted mean pain outcomes between groups at 12 months while accounting for clustering by patient and centre. Secondary outcomes will be analysed using ordinal logistic regression, Cox proportional hazards regression, and logistic regression. Missing data will be handled using multiple imputation, and sensitivity analyses using inverse probability weighting will assess the impact of reoperations and selection bias
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults diagnosed with and operated for CMC1 OA (ICD-10 M18*) | – | –1. Trapeziectomy (TE) with or without tendon adjunct according to routine practice with Flexor Carpi Radialis/Extensor Carpi Radialis Longus/Abductor Pollicis Longus/Palmaris Longus). 2. Total joint thumb base dual mobility arthroplastyDual mobility TJA |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.
Key inclusion criteria (1 listed)
- adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.
Key exclusion criteria (4 listed)
- Bilateral CMC-1 surgery or other simultaneous hand interventions
- Previous CMC-1 surgery on the affected hand
- Inflammatory joint disease affecting the hands (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- 30% missing baseline (preoperative) variables
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
Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire.
Time frame: Baseline and 12 months postoperatively
Pain on load motion assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.
12 secondary outcomes
Change from baseline to 12 months in pain on unloaded motion measured with the HAKIR questionnaire
Time frame: Baseline and 12 months after surgery
Change from baseline to 12 months in pain at rest measured with the HQ-8 questionnaire
Time frame: Baseline and 12 months postoperatively
Change from baseline to 12 months in stiffness measured with the HQ-8 questionnaire
Time frame: Baseline and 12 months postoperatively
Change from baseline to 12 months in weakness measured with the HQ-8 questionnaire
Time frame: Baseline and 12 months postoperatively
Change from baseline to 12 months in activities of daily living measured with the HQ-8 questionnaire
Time frame: Baseline and 12 months postoperatively
Change from baseline to 12 months in Quick Disabilities of Arm, Shoulder and Hand Questionnaire (Quick DASH)
Time frame: Baseline and 12 months postoperatively
Change in key pinch strength
Time frame: Baseline and 12 months postoperatively
Change in grip strength
Time frame: Baseline and 12 months postoperatively
Change in thumb radial abduction
Time frame: Baseline and 12 months postoperatively
Change in thumb plamar abduction
Time frame: From preoperatively to 12 months postoperatively
Time to first reoperation* of the index hand
Time frame: primary horizon: 12 months; secondary: maximum available follow-up
Risk of any (non-reoperation) complication within 12 months
Time frame: within 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided. Data generated and analyzed during this study are stored within HAKIR and are subject to Swedish data protection legislation and the GDPR. Due to legal and ethical restrictions, individual-level participant data cannot be made publicly available. Access to de-identified study data may be granted to qualified researchers upon reasonable request and subject to approval by the Swedish Ethical Review Authority and the HAKIR steering committee. Access to the statistical code will be granted after reasonable request.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis in the Carpometacarpal (CMC) Joint, run by Karolinska Institutet.
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 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: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire. (time frame: Baseline and 12 months postoperatively). 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 13 May 2026.