Thumb OsteoarthritisT3NCT07552831
Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis
A study testing trapeziometacarpal arthroplasty and Trapeziectomy in people with Thumb Osteoarthritis, run by Sahlgrenska University Hospital.
Trial summary
Thumb carpometacarpal osteoarthritis is common and may cause severe pain and functional limitation. Trapeziectomy is widely used, whereas prosthetic arthroplasty may offer faster early recovery. However, detailed information on early postoperative and long-term radiological outcomes remains limited. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- trapeziometacarpal arthroplasty and Trapeziectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
- Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-3.
- For Eaton grade 2, age ≥50 years.
- Age 18-69 years.
- Provision of written informed consent.
Who cannot join
- Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
- Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
- Post-traumatic thumb carpometacarpal osteoarthritis.
- Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
- Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
- Osteoporosis/osteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).
Show all 11Show fewer
- Ongoing systemic corticosteroid treatment.
- Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).
- Cognitive impairment preventing reliable participation.
- Ongoing, or suspected ongoing, alcohol or drug misuse.
- Insufficient Swedish language proficiency to complete the questionnaires.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Thumb carpometacarpal osteoarthritis is common and may cause severe pain and functional limitation. Trapeziectomy is widely used, whereas prosthetic arthroplasty may offer faster early recovery. However, detailed information on early postoperative and long-term radiological outcomes remains limited.
This is a single-centre, blinded randomised controlled trial at Sahlgrenska University Hospital, Gothenburg, Sweden. Adults aged 18-69 years with symptomatic thumb carpometacarpal osteoarthritis (Eaton grade 2-3) refractory to at least 3 months of non-operative treatment will be randomised 1:1 to trapeziometacarpal prosthetic arthroplasty or trapeziectomy. The primary outcome is day-by-day pain (registration on a numeric rating scale NRS, 0-10). Secondary outcomes include day-by-day analgesic consumption for 90 days, orthosis use after cast removal, patient-reported function (HQ-8, QuickDASH, and Nelson score) at 30, 45, 60, 75 and 90 days, assessor-measured range of motion and strength at 45 and 90 days, and long-term clinical follow-up at 6 months and 1, 2, 5 and 10 years. Cone beam computed tomography will be obtained in the arthroplasty group at 1 week postoperatively as reference and at 6 months and 1, 2, 5 and 10 years to assess implant position, migration and loosening. The target sample size is 64 participants (32 per group), providing 95% power to detect a 1-point between-group difference on the pain scale. Analyses will follow the intention-to-treat principle.
Read the detailed description
Aim and objectives The primary aim is to compare early postoperative pain trajectories after CMC-1 arthroplasty versus trapeziectomy for symptomatic thumb carpometacarpal osteoarthritis, using day-by-day patient-reported pain measurements during the first 90 postoperative days.
Secondary aims are to compare:
(i) Daily analgesic consumption during the first 90 postoperative days (ii) Orthosis use after cast removal (iii) Patient-reported hand/upper limb function using HQ-8, QuickDASH and Nelson score (iv) Blinded clinical measures of thumb range of motion, grip strength and pinch strength (v) Long-term clinical outcomes up to 10 years. Additionally, in the arthroplasty group, a long-term aim is to evaluate migration and radiological signs of implant loosening using cone beam computed tomography (CBCT). Similarly, in the trapeziectomy group, CBCT will be used to monitor and quantify metacarpal 1 proximal migration.
This protocol has been prepared in accordance with SPIRIT 2025 guidance [18], and includes a PRO EDI participant characteristics (Table 1).
Trial design This is a single-centre, assessor-blinded randomised controlled trial (RCT) with 1:1 allocation to prosthetic CMC-1 arthroplasty or trapeziectomy.
Study setting The study will be conducted at the Hand Surgery Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden. All operations will be performed by surgeons experienced in both techniques at least level 3 according to Giddins-Tang classification [19] and have at minimum overcome the previously described learning curve thresholds [20,21].
Eligibility criteria
Inclusion criteria:
- Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
- Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-4.
- For Eaton grade 2, age ≥50 years.
- Age 18-69 years.
- Provision of written informed consent.
Exclusion criteria:
- Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
- Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
- Post-traumatic thumb carpometacarpal osteoarthritis.
- Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
- Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
- Osteoporosis/osteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).
- Ongoing systemic corticosteroid treatment.
- Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).
- Cognitive impairment preventing reliable participation.
- Ongoing, or suspected ongoing, alcohol or drug misuse.
- Insufficient Swedish language proficiency to complete the questionnaires.
Participant identification, recruitment and consent Potential participants will be identified among patients referred for surgical evaluation of symptomatic thumb carpometacarpal osteoarthritis at the study site. Eligible patients will receive verbal and written information about the study. Written informed consent will be obtained before any study-specific data collection.
At baseline, participants will complete the HQ-8, QuickDASH and Nelson score questionnaires. Baseline demographic characteristics will be recorded in line with the PRO
- Conditions
- Thumb Osteoarthritis
- Being tested
- trapeziometacarpal arthroplasty, Trapeziectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trapeziometacarpal arthroplastyProcedure or surgery
Participants allocated to arthroplasty will undergo implantation of the Touch® CMC-1 prosthesis according to routine practice at the study site. Surgery will be performed by experienced hand surgeons. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free.
TrapeziectomyProcedure or surgery
Participants allocated to trapeziectomy will undergo surgical excision of the trapezium without tendon interposition according to routine practice at the study site. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free
| Study group | Role | What they receive |
|---|---|---|
| Trapeziometacarpal joint arthroplasty | Experimental | Implantation of the Touch® CMC-1 prosthesis Receives: Procedure: trapeziometacarpal arthroplasty |
| Trapeziectomy | Active comparator | Surgical excision of the trapezium Receives: Procedure: trapeziometacarpal arthroplasty; Procedure: Trapeziectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Patient-reported pain at the thumb base, measured on a 0-10 numeric rating scale (0 = no pain, 10 = worst imaginable pain).
Measured: daily for three months
Secondary outcomes (8)
Analgesics used
Daily registration of analgesic consumption
Measured: daily for three months
Use of Orthosis
- Orthosis use and perceived importance recorded weekly after cast removal
Measured: Daily for three months
Patient-reported thumb symptoms
measured with Nelson score (a disease specific questionnaire)
Measured: at 30, 45, 60, 75 and 90 postoperative days
Patient-reported upper extremity function
measured with QuickDASH questionnaire
Measured: at 30, 45, 60, 75 and 90 postoperative days
Patient-reported hand function
measured with HQ-8 questionnaire
Measured: at 30, 45, 60, 75 and 90 postoperative days
Range of motion
Objective thumb range of motion (radial and volar abduction) measured by a blinded assessor
Measured: at 45 and 90 postoperative days and at 6 months and 1, 2, 5 and 10 years.
Strength
Grip strength and pinch strength measured by a blinded assessor
Measured: at 45 and 90 postoperative days and at 6 months and 1, 2, 5 and 10 years.
Migration of prosthesis on cone beam computed tomography
- Long-term radiological assessment with CBCT in the arthroplasty group to assess implant position, migration and loosening and to assess metacarpal 1 migration in the trapeziectomy group
Measured: at 6 months and 1, 2, 5 and 10 years (with a 1-week reference scan).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (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 Thumb OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Principal investigator, Joakim Stromberg, Sahlgrenska University Hospital
- Investigators
- Joakim Stromberg, MD, PhD, Principal investigator, Sahlgrenska University Hospital, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552831
- Sponsor's protocol ID
- The T3 Study
- Acronym
- T3
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapeziometacarpal Joint Arthroplasty Versus Trapeziectomy for Thumb Carpometacarpal Osteoarthritis
- ClinicalTrials.gov ID
- NCT07552831
- Acronym / sponsor ID
- T3 / The T3 Study
- Conditions
- Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 27 Apr 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 osteoarthritis is common and may cause severe pain and functional limitation. Trapeziectomy is widely used, whereas prosthetic arthroplasty may offer faster early recovery. However, detailed information on early postoperative and long-term radiological outcomes remains limited.
This is a single-centre, blinded randomised controlled trial at Sahlgrenska University Hospital, Gothenburg, Sweden. Adults aged 18-69 years with symptomatic thumb carpometacarpal osteoarthritis (Eaton grade 2-3) refractory to at least 3 months of non-operative treatment will be randomised 1:1 to trapeziometacarpal prosthetic arthroplasty or trapeziectomy. The primary outcome is day-by-day pain (registration on a numeric rating scale NRS, 0-10). Secondary outcomes include day-by-day analgesic consumption for 90 days, orthosis use after cast removal, patient-reported function (HQ-8, QuickDASH, and Nelson score) at 30, 45, 60, 75 and 90 days, assessor-measured range of motion and strength at 45 and 90 days, and long-term clinical follow-up at 6 months and 1, 2, 5 and 10 years. Cone beam computed tomography will be obtained in the arthroplasty group at 1 week postoperatively as reference and at 6 months and 1, 2, 5 and 10 years to assess implant position, migration and loosening. The target sample size is 64 participants (32 per group), providing 95% power to detect a 1-point between-group difference on the pain scale. Analyses will follow the intention-to-treat principle.
Detailed description
Aim and objectives The primary aim is to compare early postoperative pain trajectories after CMC-1 arthroplasty versus trapeziectomy for symptomatic thumb carpometacarpal osteoarthritis, using day-by-day patient-reported pain measurements during the first 90 postoperative days.
Secondary aims are to compare:
(i) Daily analgesic consumption during the first 90 postoperative days (ii) Orthosis use after cast removal (iii) Patient-reported hand/upper limb function using HQ-8, QuickDASH and Nelson score (iv) Blinded clinical measures of thumb range of motion, grip strength and pinch strength (v) Long-term clinical outcomes up to 10 years. Additionally, in the arthroplasty group, a long-term aim is to evaluate migration and radiological signs of implant loosening using cone beam computed tomography (CBCT). Similarly, in the trapeziectomy group, CBCT will be used to monitor and quantify metacarpal 1 proximal migration.
This protocol has been prepared in accordance with SPIRIT 2025 guidance [18], and includes a PRO EDI participant characteristics (Table 1).
Trial design This is a single-centre, assessor-blinded randomised controlled trial (RCT) with 1:1 allocation to prosthetic CMC-1 arthroplasty or trapeziectomy.
Study setting The study will be conducted at the Hand Surgery Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden. All operations will be performed by surgeons experienced in both techniques at least level 3 according to Giddins-Tang classification [19] and have at minimum overcome the previously described learning curve thresholds [20,21].
Eligibility criteria
Inclusion criteria:
- Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
- Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-4.
- For Eaton grade 2, age ≥50 years.
- Age 18-69 years.
- Provision of written informed consent.
Exclusion criteria:
- Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
- Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
- Post-traumatic thumb carpometacarpal osteoarthritis.
- Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
- Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
- Osteoporosis/osteopenia of such severity that secure cup placement in the trapezium is not possible (for arthroplasty).
- Ongoing systemic corticosteroid treatment.
- Other hand surgical condition in the same hand that could confound outcomes (e.g., carpal tunnel syndrome or de Quervain tenosynovitis).
- Cognitive impairment preventing reliable participation.
- Ongoing, or suspected ongoing, alcohol or drug misuse.
- Insufficient Swedish language proficiency to complete the questionnaires.
Participant identification, recruitment and consent Potential participants will be identified among patients referred for surgical evaluation of symptomatic thumb carpometacarpal osteoarthritis at the study site. Eligible patients will receive verbal and written information about the study. Written informed consent will be obtained before any study-specific data collection.
At baseline, participants will complete the HQ-8, QuickDASH and Nelson score questionnaires. Baseline demographic characteristics will be recorded in line with the PRO
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Trapeziometacarpal joint arthroplasty | Experimental | Procedure: trapeziometacarpal arthroplastyImplantation of the Touch® CMC-1 prosthesis |
| Trapeziectomy | Active comparator | Procedure: trapeziometacarpal arthroplasty, Procedure: TrapeziectomySurgical excision of the trapezium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain at the base of the thumb affecting activities of daily living and insufficient response to at least 3 months of non-operative treatment (orthosis, non-steroidal anti-inflammatory drugs, and/or corticosteroid injections).
- Radiographic thumb carpometacarpal osteoarthritis, Eaton grade 2-3.
- For Eaton grade 2, age ≥50 years.
- Age 18-69 years.
- Provision of written informed consent.
Key exclusion criteria (11 listed)
- Symptomatic osteoarthritis of adjacent joints (e.g., scaphotrapeziotrapezoid joint, STT-joint).
- Need for concurrent surgery in the metacarpophalangeal joint (e.g. arthrodesis or capsulodesis).
- Post-traumatic thumb carpometacarpal osteoarthritis.
- Previous surgery for thumb carpometacarpal osteoarthritis in the contralateral hand.
- Inflammatory arthritis (e.g., rheumatoid arthritis or systemic lupus erythematosus).
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 |
|---|---|---|
| trapeziometacarpal arthroplastyParticipants allocated to arthroplasty will undergo implantation of the Touch® CMC-1 prosthesis according to routine practice at the study site. Surgery will be performed by experienced hand surgeons. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free. | Procedure or surgery | Trapeziectomy, Trapeziometacarpal joint arthroplasty |
| TrapeziectomyParticipants allocated to trapeziectomy will undergo surgical excision of the trapezium without tendon interposition according to routine practice at the study site. Postoperatively, the thumb will be immobilised in a thumb spica cast that leaves the interphalangeal joint free | Procedure or surgery | Trapeziectomy |
Primary outcome
Pain level
Time frame: daily for three months
Patient-reported pain at the thumb base, measured on a 0-10 numeric rating scale (0 = no pain, 10 = worst imaginable pain).
8 secondary outcomes
Analgesics used
Time frame: daily for three months
Use of Orthosis
Time frame: Daily for three months
Patient-reported thumb symptoms
Time frame: at 30, 45, 60, 75 and 90 postoperative days
Patient-reported upper extremity function
Time frame: at 30, 45, 60, 75 and 90 postoperative days
Patient-reported hand function
Time frame: at 30, 45, 60, 75 and 90 postoperative days
Range of motion
Time frame: at 45 and 90 postoperative days and at 6 months and 1, 2, 5 and 10 years.
Strength
Time frame: at 45 and 90 postoperative days and at 6 months and 1, 2, 5 and 10 years.
Migration of prosthesis on cone beam computed tomography
Time frame: at 6 months and 1, 2, 5 and 10 years (with a 1-week reference scan).
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 1 May 2026.
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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.
Joakim Stromberg, MD, PhD principal investigator
Sahlgrenska University Hospital, University of Gothenburg
Questions about this trial
What is this clinical trial studying?
A study testing trapeziometacarpal arthroplasty and Trapeziectomy in people with Thumb Osteoarthritis, run by Sahlgrenska University Hospital.
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 11 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: opening soon, as of the sponsor's last update on 1 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?
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 Joakim Stromberg, Md,PhD (+46768341327, joakim.stromberg@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: daily for three months). 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 1 May 2026.