Thumb OsteoarthritisFINTASYNCT05127005
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
A study testing Trapeziectomy in people with Thumb Osteoarthritis, run by Tampere University Hospital at 4 sites in Finland.
Trial summary
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Trapeziectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 4 sitesFinland
- Study dates
- 20 Jan 2022to 31 Mar 2033
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living
- Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months.
- Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)
- Age > 45 years
- ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
- Ability to speak, understand and read in the language of the clinical site
- Provision of informed consent from the participant
- Shared decision to proceed with surgical treatment of CMC-1 OA
Who cannot join
- Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy
- Neurologic condition affecting the function or symptoms of the upper extremity
- <6 months from other surgical procedure of the upper extremities
- Rheumatoid arthritis or other inflammatory joint disease
- Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides
- Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side
- >45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)
- Patient is unable to continue his/her current job due to thumb pain
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 4 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Susanna Stjernberg-Salmela, MD, PhD, +358504274955, Susanna.Stjernberg-Salmela@hus.fi
- Recruiting
Central Finland Hospital Nova
Jyväskylä
Olli-Pekka Kangasniemi, MD, +358504009659, olli-pekka.kangasniemi@hyvaks.fi
Kati MJ Jaatinen, MSc, kati.jaatinen@hyvaks.fi
- Recruiting
Kuopio University Central Hospital
Kuopio
Matti Juntunen, MD, +35817 173311, matti.juntunen@pshyvinvointialue.fi
- Recruiting
Tampere University Hospital
Tampere
Jarkko Jokihaara
About this study
Official title: A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.
Read the detailed description
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Rated Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Trapeziectomy, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrapeziectomyProcedure or surgery
Surgical excision of trapezium bone
ShamProcedure or surgery
Skin incision only
| Study group | Role | What they receive |
|---|---|---|
| Trapeziectomy | Experimental | Trapeziectomy Receives: Procedure: Trapeziectomy |
| Placebo surgery | Placebo comparator | Placebo surgery Receives: Procedure: Sham |
| Non-randomized observational arm | Other | Non-randomized observational arm (trapeziectomy, not blinded) Receives: Procedure: Trapeziectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rated wrist and hand evaluation (PRWHE)
PROM questionnaire: PRWHE is a valid wrist and hand-specific composite measure comprising pain and function.
Measured: 6 months after randomization
Secondary outcomes (11)
Patient rated wrist and hand evaluation (PRWHE)
PROM questionnaire: PRWHE is a valid wrist and hand-specific composite measure comprising pain and function.
Measured: At baseline, 3 months, and 1, 2, 5 years after randomization, 6 months after possible secondary trapeziectomy
Global improvement (PGI-C)
PROM, question (Likert scale)
Measured: At 3 and 6 months, and 1, 2, and 5 years after randomization, 6 months after possible secondary trapeziectomy
Patient Acceptable Symptom State (PASS)
PROM, question (Likert scale)
Measured: At 3 and 6 months, and 1, 2, and 5 years after randomization, 6 months after possible secondary trapeziectomy
Patient rated wrist and hand evaluation (PRWHE) - pain subscale
PROM questionnaire
Measured: At baseline, 3 months, 6 months, and 1, 2, 5 years after randomization, 6 months after possible secondary trapeziectomy
Patient rated wrist and hand evaluation (PRWHE) - function subscale
PROM questionnaire
Measured: At baseline, 3 months, 6 months, and 1, 2, 5 years after randomization, 6 months after possible secondary trapeziectomy
EuroQol EQ-5D-5L, index value
PROM, health-related quality of life questionnaire
Measured: At baseline, 3 and 6 months, and 1, 2, and 5 years after randomization
EuroQol EQ-5D-5L, Visual Analogue Scale (VAS) (EQ VAS)
PROM, health-related quality of life questionnaire
Measured: At baseline, 3 and 6 months, and 1, 2, and 5 years after randomization
Grip strength
Measured with dynamometer
Measured: At baseline, 6 months after randomization
Pinch strength
Measured with dynamometer
Measured: At baseline, 6 months after randomization
Pain medication
Frequency of pain medication for thumb pain in the past week (categorial, 4 step)
Measured: At baseline, 3 months, 6 months, and 1, 2, 5 years after randomization
Harms
Harms and healthcare contacts related to the operated hand will be collected systematically and unprompted using a standardized electronic case report files (eCRF). Events will be classified by type (Adverse event, Serious Adverse Event, Suspected Unexpected Serious Adverse Reaction), attribution, timing, and nature.
Measured: After intervention (intraoperative), at 3 months, 6 months, and 1, 2, 5 years after randomization and as unprompted participant contacts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start20 Jan 2022
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2033 (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 Tampere 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nova, Central Finland, Kuopio University Hospital, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Jarkko Jokihaara, Tampere University Hospital
- Investigators
- Jarkko Jokihaara, Study chair, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127005
- Sponsor's protocol ID
- TAUH_FINTASY
- Acronym
- FINTASY
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2021
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this trial IPD sharing is restricted by data protection regulations
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
- ClinicalTrials.gov ID
- NCT05127005
- Acronym / sponsor ID
- FINTASY / TAUH_FINTASY
- Conditions
- Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Hospital Nova, Central Finland, Kuopio University Hospital, Helsinki University Central Hospital
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2033 (estimated)
- First posted
- 19 Nov 2021 (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 multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.
Detailed description
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Rated Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trapeziectomy | Experimental | Procedure: TrapeziectomyTrapeziectomy |
| Placebo surgery | Placebo comparator | Procedure: ShamPlacebo surgery |
| Non-randomized observational arm | Other | Procedure: TrapeziectomyNon-randomized observational arm (trapeziectomy, not blinded) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living
- Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months.
- Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)
- Age > 45 years
- ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
Key exclusion criteria (8 listed)
- Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy
- Neurologic condition affecting the function or symptoms of the upper extremity
- <6 months from other surgical procedure of the upper extremities
- Rheumatoid arthritis or other inflammatory joint disease
- Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides
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 |
|---|---|---|
| TrapeziectomySurgical excision of trapezium bone | Procedure or surgery | Non-randomized observational arm, Trapeziectomy |
| ShamSkin incision only | Procedure or surgery | Placebo surgery |
Primary outcome
Patient rated wrist and hand evaluation (PRWHE)
Time frame: 6 months after randomization
PROM questionnaire: PRWHE is a valid wrist and hand-specific composite measure comprising pain and function.
11 secondary outcomes
Patient rated wrist and hand evaluation (PRWHE)
Time frame: At baseline, 3 months, and 1, 2, 5 years after randomization, 6 months after possible secondary trapeziectomy
Global improvement (PGI-C)
Time frame: At 3 and 6 months, and 1, 2, and 5 years after randomization, 6 months after possible secondary trapeziectomy
Patient Acceptable Symptom State (PASS)
Time frame: At 3 and 6 months, and 1, 2, and 5 years after randomization, 6 months after possible secondary trapeziectomy
Patient rated wrist and hand evaluation (PRWHE) - pain subscale
Time frame: At baseline, 3 months, 6 months, and 1, 2, 5 years after randomization, 6 months after possible secondary trapeziectomy
Patient rated wrist and hand evaluation (PRWHE) - function subscale
Time frame: At baseline, 3 months, 6 months, and 1, 2, 5 years after randomization, 6 months after possible secondary trapeziectomy
EuroQol EQ-5D-5L, index value
Time frame: At baseline, 3 and 6 months, and 1, 2, and 5 years after randomization
EuroQol EQ-5D-5L, Visual Analogue Scale (VAS) (EQ VAS)
Time frame: At baseline, 3 and 6 months, and 1, 2, and 5 years after randomization
Grip strength
Time frame: At baseline, 6 months after randomization
Pinch strength
Time frame: At baseline, 6 months after randomization
Pain medication
Time frame: At baseline, 3 months, 6 months, and 1, 2, 5 years after randomization
Harms
Time frame: After intervention (intraoperative), at 3 months, 6 months, and 1, 2, 5 years after randomization and as unprompted participant contacts
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 2 Nov 2026.
- Individual participant dataSharing planned: No. In this trial IPD sharing is restricted by data protection regulations
Related trials for Thumb Osteoarthritis
Active, not recruitingPhase 4
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
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, 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.
Jarkko Jokihaara study chair
Tampere University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trapeziectomy in people with Thumb Osteoarthritis, run by Tampere University Hospital at 4 sites in Finland.
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 8 inclusion and 8 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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. Some participants in this study may receive a placebo. 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 Jarkko Jokihaara (+3583311611, jarkko.jokihaara@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rated wrist and hand evaluation (PRWHE) (time frame: 6 months after randomization). 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 2 Nov 2026.