Thumb OsteoarthritisNCT04210687
Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
A study testing trapeziometacarpal limited excision and Trapeziectomy in people with Thumb Osteoarthritis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- trapeziometacarpal limited excision and Trapeziectomy
- 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
- 9 Mar 2020to 30 May 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
- Pain at rest.
- Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)
Who cannot join
- Rheumatoid arthritis.
- Ongoing infection in the hand or wrist. -
- History of gout or pseudo gout.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Intra-articular injection in the affected joint within 6 months.
- Eaton Littler class 4 (STT joint involved).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.
- Conditions
- Thumb Osteoarthritis
- Being tested
- trapeziometacarpal limited excision, Trapeziectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trapeziometacarpal limited excisionProcedure or surgery
Narrow pseudarthrosis CMC1
TrapeziectomyProcedure or surgery
Simple trapeziectomy
| Study group | Role | What they receive |
|---|---|---|
| Trapeziectomy | Active comparator | Standard simple trapeziectomy, no pins. Receives: Procedure: Trapeziectomy |
| trapeziometacarpal limited excision | Active comparator | Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint. Receives: Procedure: trapeziometacarpal limited excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on load NRS (numerical rating scale)
Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Secondary outcomes (8)
Change in Nelson Thumb score
0-100 p, higher score = less disability
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Change in EQ-5D
Weight mean value: 0=dead, 1= healthy
Measured: 1, 3 and 5 years postoperatively
Change in DASH - Disability of the Arm, Shoulder and Hand
0-100 p, higher score = more disability
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Change in PRWHE - Patient-Rated Wrist and Hand Evaluation
0-100 p, higher score = more disability
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Change in HADS - Change hospital Anxiety and Depression score
2 subscores for anxiety (0-21P) and depression (0-21p), higher score = worse
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Change in PCS - Pain Catastrophizing Score
0-52, higher score = more pain catastrophizing
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Change in Thumb base motion
radial and palmar abduction of the first metacarpal (degrees).
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Change in thumb strength
Key pinch and pinch strength (Kg)
Measured: Preoperatively, 1, 3 and 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start9 Mar 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion30 May 2028 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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, MD PhD, Principal investigator, Karolinska Instituet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210687
- Sponsor's protocol ID
- TEvsTLE
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2019
- Last updated
- 10 Aug 2026
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
- ClinicalTrials.gov ID
- NCT04210687
- Acronym / sponsor ID
- TEvsTLE
- Conditions
- Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 26 Dec 2019 (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.
A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trapeziectomy | Active comparator | Procedure: TrapeziectomyStandard simple trapeziectomy, no pins. |
| trapeziometacarpal limited excision | Active comparator | Procedure: trapeziometacarpal limited excisionTrapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
- Pain at rest.
- Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)
Key exclusion criteria (6 listed)
- Rheumatoid arthritis.
- Ongoing infection in the hand or wrist. -
- History of gout or pseudo gout.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Intra-articular injection in the affected joint within 6 months.
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 limited excisionNarrow pseudarthrosis CMC1 | Procedure or surgery | trapeziometacarpal limited excision |
| TrapeziectomySimple trapeziectomy | Procedure or surgery | Trapeziectomy |
Primary outcome
Change in pain on load NRS (numerical rating scale)
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively
8 secondary outcomes
Change in Nelson Thumb score
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in EQ-5D
Time frame: 1, 3 and 5 years postoperatively
Change in DASH - Disability of the Arm, Shoulder and Hand
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in PRWHE - Patient-Rated Wrist and Hand Evaluation
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in HADS - Change hospital Anxiety and Depression score
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in PCS - Pain Catastrophizing Score
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in Thumb base motion
Time frame: Preoperatively, 1, 3 and 5 years postoperatively
Change in thumb strength
Time frame: Preoperatively, 1, 3 and 5 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 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
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Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
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Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
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. This study is not recruiting at the moment.
Maria Wilcke, MD PhD principal investigator
Karolinska Instituet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trapeziometacarpal limited excision and Trapeziectomy in people with Thumb Osteoarthritis, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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?
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 in pain on load NRS (numerical rating scale) (time frame: Preoperatively, 1, 3 and 5 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 10 Aug 2026.