Osteoarthritis of the CMC-1 JointTRACENCT07178223
TRACE - Thumb Base Replacement Arthroplasty for Osteoarthritis.
A study testing Arthroplasty CMC-1 in people with Osteoarthritis of the CMC-1 Joint, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Osteoarthritis in the base of the thumb is one of the most common forms of hand arthritis. It usually appears in middle age, particularly in women, and can cause significant pain and loss of function. Early treatment often includes splints, painkillers, joint protection techniques, or steroid injections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of the CMC-1 Joint
- What is being tested?
- Arthroplasty CMC-1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2025to 31 Dec 2038
- 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
- Osteoarthritis in the thumb base. Radiological Eaton class 1-3 (Ladd et al. 2015).
- Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.
- The inclusion criteria are identical to those of the control population.
Who cannot join
- Rheumatoid arthritis.
- Ongoing infection in the hand or wrist.
- History of gout or pseudogout in the hand.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Chronic pain syndrome / centralized pain.
- Intra-articular corticosteroid injection in the affected joint within 3 months. -Eaton Littler class 4 (symptomatic STT joint osteoarthritis).
- The previously described exclusion criteria are identical to those of the control population. In addition patients with severe deformation of the trapezium, to the extent that it is not possible to place a prosthetic cup, will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Handkirurgiska kliniken Södersjukhuset
Stockholm, 11883
Maria Wilcke, MD, Associate professor, +4681236022, maria.wilcke@ki.se
johanna Von Kieseritzky, MD, PhD, 0812362000, johanna.von.kieseritzky@ki.se
About this study
Official title: TRACE - A Single Arm Trial of Thumb Base Replacement Arthroplasty for Osteoarthritis Compared to External Controls
Osteoarthritis in the base of the thumb is one of the most common forms of hand arthritis. It usually appears in middle age, particularly in women, and can cause significant pain and loss of function. Early treatment often includes splints, painkillers, joint protection techniques, or steroid injections. If these measures are not enough, surgery is considered.
The current standard operation in Sweden is trapeziectomy-removing the trapezium. This usually gives good pain relief at rest, but many patients continue to experience pain when loading the hand and reduced grip strength. Another surgical option is trapeziometacarpal limited excision (TLE), where only part of the bone is removed to keep the thumb slightly longer, which may improve strength. Both procedures are non-implant surgeries.
Read more
A newer alternative is total joint arthroplasty (TJA), where the joint is replaced with a prosthesis. Early studies suggest that this may allow for quicker recovery and possibly better strength compared to trapeziectomy. However, it is more expensive and carries higher risks, such as implant loosening or dislocation. So far, research has not proven that it offers better long-term results.
The TRACE study (A single arm trial of Thumb base Replacement Arthroplasty for osteoarthritis Compared to External controls) is designed to help answer this question. Instead of randomizing patients, this study will follow a group of people receiving thumb joint replacement and compare them to an existing group of patients who already took part in a randomized trial of trapeziectomy and TLE. This design allows the researchers to study results more quickly and with fewer resources, while still ensuring meaningful comparisons.
The main research question of this study is whether joint replacement gives better pain relief when loading the thumb 10 years after surgery compared to traditional non-implant operations in patients with painful thumb base osteoarthritis. Secondary questions include whether joint replacement improves patient-reported outcomes, hand function, and strength, and whether it leads to more or fewer complications at 1, 3, and 5 years after surgery.
90 patients will be included in the replacement group, using a dual mobility prosthesis. Their outcomes will be compared with 90 patients from the earlier trial (45 trapeziectomy and 45 limited trapeziometacarpal joint resection - TLE). The study will track pain, daily hand function, strength, range of motion, and complications such as infection or the need for further surgery. Data will be collected regularly for up to 10 years.
- Conditions
- Osteoarthritis of the CMC-1 Joint
- Being tested
- Arthroplasty CMC-1
- Keywords
- cmc-1, osteoarthritis, thumb base, Arthroplasty, prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroplasty CMC-1Procedure or surgery
Touch Touch® dual-mobility Arthroplasty CMC-1 joint (Kerimed). Dorsal approach. Conical cup. Soft dressing 3 weeks. Loading allowed after 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty | Other | Arthroplasty CMC-1 Receives: Procedure: Arthroplasty CMC-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on load in the thumb 10 years postoperatively.
Pain on load is rated with a self-administered 11-point numerical rating scale (NRS) 0-100 from the HQ-7 questionnaire. Higher score means more pain. The participants are asked to rate the pain the previous week.
Measured: 10 years postoperatively
Secondary outcomes (8)
Pain on load in the thumb 3 and 6 months, 1, 3, and 5 years postoperatively.
Pain on load is rated with a self-administered 11-point numerical rating scale (NRS) 0-100 from the HQ-7 questionnaire. Higher score means mote pain. The participants are asked to rate the pain the previous week.
Measured: from enrollment to 5 years postoperatively
HQ-8 score 3 and 6 months, 1,3, 5 and 10 years postoperatively
Self-administered 11-point numerical rating scale (NRS) 0-100 symptoms questionnaire. Symptoms inlcude pain at rest, pain on motion, stiffness, weakness. Higher score means more symptoms. HQ-8 is the symptom-rating scale in the Swedish Hand surgical quality registry (HAKIR).
Measured: From enrollment to 10 years postoperatively
Patient-rated Wrist and Hand (PRWHE) score 3 and 6 months, 1,3, 5 and 10 years postoperatively
Patient-rated Wrist and Hand (PRWHE). Scale 0-100, higher score means more pain and disability,
Measured: From enrollment to 10 years postoperatively
Distability of the Arm, Hand and Shoulder (DASH) score 3 and 6 months, 1,3, 5 and 10 years postoperatively
Distability of the Arm, Hand and Shoulder (DASH) score range from 0 to 100, higher score means more disability,
Measured: From enrollment to 10 years postoperatively.
Thumb range of motion 3 and 6 months, 1,3, 5 and 10 years postoperatively
Palmar and radial abduction (degrees) of the first metacarpal measured with a goniometer
Measured: From enrollment to 10 years postoperatively
Adverse events
Number of particiant with a diagnosed infection, complex regional pain syndrome (CRPS), superficial radial sensory nerve injury or revision surgery required.
Measured: From enrollment to 10 years postoperatively.
Thumb strength 1,3, 5 and 10 years postoperatively
Key pinch and three-finger pinch measured with a pinch gauge (kilograms).
Measured: From enrollment to 10 years postoperatively
Hand strength 1,3, 5 and 10 years postoperatively
Full hand grip strength measured with Jamar (kilograms).
Measured: From enrollment to 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the CMC-1 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm with external control
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Wilcke, Karolinska Institutet
- Investigators
- Maria Wilcke, Associate professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178223
- Sponsor's protocol ID
- Thumb base arthroplasty
- Acronym
- TRACE
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A description of the variables collected throughout the trial and used in the results publication will be provided when the study is finished.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACE - A Single Arm Trial of Thumb Base Replacement Arthroplasty for Osteoarthritis Compared to External Controls
- ClinicalTrials.gov ID
- NCT07178223
- Acronym / sponsor ID
- TRACE / Thumb base arthroplasty
- Conditions
- Osteoarthritis of the CMC-1 Joint
- Keywords
- cmc-1, osteoarthritis, thumb base, Arthroplasty, prosthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 17 Sep 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.
Osteoarthritis in the base of the thumb is one of the most common forms of hand arthritis. It usually appears in middle age, particularly in women, and can cause significant pain and loss of function. Early treatment often includes splints, painkillers, joint protection techniques, or steroid injections. If these measures are not enough, surgery is considered.
The current standard operation in Sweden is trapeziectomy-removing the trapezium. This usually gives good pain relief at rest, but many patients continue to experience pain when loading the hand and reduced grip strength. Another surgical option is trapeziometacarpal limited excision (TLE), where only part of the bone is removed to keep the thumb slightly longer, which may improve strength. Both procedures are non-implant surgeries.
A newer alternative is total joint arthroplasty (TJA), where the joint is replaced with a prosthesis. Early studies suggest that this may allow for quicker recovery and possibly better strength compared to trapeziectomy. However, it is more expensive and carries higher risks, such as implant loosening or dislocation. So far, research has not proven that it offers better long-term results.
The TRACE study (A single arm trial of Thumb base Replacement Arthroplasty for osteoarthritis Compared to External controls) is designed to help answer this question. Instead of randomizing patients, this study will follow a group of people receiving thumb joint replacement and compare them to an existing group of patients who already took part in a randomized trial of trapeziectomy and TLE. This design allows the researchers to study results more quickly and with fewer resources, while still ensuring meaningful comparisons.
The main research question of this study is whether joint replacement gives better pain relief when loading the thumb 10 years after surgery compared to traditional non-implant operations in patients with painful thumb base osteoarthritis. Secondary questions include whether joint replacement improves patient-reported outcomes, hand function, and strength, and whether it leads to more or fewer complications at 1, 3, and 5 years after surgery.
90 patients will be included in the replacement group, using a dual mobility prosthesis. Their outcomes will be compared with 90 patients from the earlier trial (45 trapeziectomy and 45 limited trapeziometacarpal joint resection - TLE). The study will track pain, daily hand function, strength, range of motion, and complications such as infection or the need for further surgery. Data will be collected regularly for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm with external control
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty | Other | Procedure: Arthroplasty CMC-1Arthroplasty CMC-1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis in the thumb base. Radiological Eaton class 1-3 (Ladd et al. 2015).
- Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.
- The inclusion criteria are identical to those of the control population.
Key exclusion criteria (7 listed)
- Rheumatoid arthritis.
- Ongoing infection in the hand or wrist.
- History of gout or pseudogout in the hand.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Chronic pain syndrome / centralized pain.
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 |
|---|---|---|
| Arthroplasty CMC-1Touch Touch® dual-mobility Arthroplasty CMC-1 joint (Kerimed). Dorsal approach. Conical cup. Soft dressing 3 weeks. Loading allowed after 2 months. | Procedure or surgery | Arthroplasty |
Primary outcome
Pain on load in the thumb 10 years postoperatively.
Time frame: 10 years postoperatively
Pain on load is rated with a self-administered 11-point numerical rating scale (NRS) 0-100 from the HQ-7 questionnaire. Higher score means more pain. The participants are asked to rate the pain the previous week.
8 secondary outcomes
Pain on load in the thumb 3 and 6 months, 1, 3, and 5 years postoperatively.
Time frame: from enrollment to 5 years postoperatively
HQ-8 score 3 and 6 months, 1,3, 5 and 10 years postoperatively
Time frame: From enrollment to 10 years postoperatively
Patient-rated Wrist and Hand (PRWHE) score 3 and 6 months, 1,3, 5 and 10 years postoperatively
Time frame: From enrollment to 10 years postoperatively
Distability of the Arm, Hand and Shoulder (DASH) score 3 and 6 months, 1,3, 5 and 10 years postoperatively
Time frame: From enrollment to 10 years postoperatively.
Thumb range of motion 3 and 6 months, 1,3, 5 and 10 years postoperatively
Time frame: From enrollment to 10 years postoperatively
Adverse events
Time frame: From enrollment to 10 years postoperatively.
Thumb strength 1,3, 5 and 10 years postoperatively
Time frame: From enrollment to 10 years postoperatively
Hand strength 1,3, 5 and 10 years postoperatively
Time frame: From enrollment to 10 years postoperatively
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 23 Sep 2025.
- Individual participant dataSharing planned: Yes. A description of the variables collected throughout the trial and used in the results publication will be provided when the study is finished.
Related trials for Osteoarthritis of the CMC-1 Joint
Active, not recruiting
A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Osteoarthritis Thumb
RecruitingObservational study
Study on Basal Joint Arthritis Prospective
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
RecruitingObservational study
TOUCH® CMC 1 New Enrollment US Study
Osteoarthritis Thumb, Thumb Carpometacarpal Joint Osteoarthritis
Recruiting
Variable Immobilization Protocol for Arthroplasty of the Carpometacarpal Joint of the Thumb
Thumb 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.
Maria Wilcke, Associate professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroplasty CMC-1 in people with Osteoarthritis of the CMC-1 Joint, run by Karolinska Institutet at 1 site in Sweden.
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 3 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 23 Sep 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 Sweden. 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 Maria Wilcke, MD, Associate professor (+4681236022, maria.wilcke@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on load in the thumb 10 years postoperatively. (time frame: 10 years 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 23 Sep 2025.