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Thumb OsteoarthritisBASTIONNCT07569549

Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy

A study testing Implantation of trapeziometacarpal prosthesis and Trapeziectomy with Capsuloplasty in people with Thumb Osteoarthritis and Thumb Carpometacarpal Joint Osteoarthritis, run by Uppsala University at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Implantation of trapeziometacarpal prosthesis and Trapeziectomy with Capsuloplasty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSweden
Study dates
4 Sep 2026to Mar 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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 40-80 years at inclusion
  • CMC-joint osteoarthritis grade 1-3 (Eaton-Littler classification)
  • Rest pain or pain reducing hand function with indication for surgery
  • Insufficient relief from non-operative treatment for ≥3 months (orthosis, OTC analgesics, cortisone injection)
  • Eligible for both prosthesis and trapezectomy per including surgeon
  • Non-smoker or complete smoking cessation ≥6 weeks prior to surgery

Who cannot join

  • Previous surgery to thumb base or STT-joint
  • Ongoing general chronic pain condition or other pain in the same hand predominant over the thumb base pain.
  • Dementia or cognitive impairment
  • Trapezium height <7 mm on plain radiograph
  • Active smoker
  • Osteoarthritis grade 4 (Eaton-Littler)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Nordin, Clinical research nurse contact

+46(0) 186119630

eva.nordin@akademiska.se

Elias Gardell, MD, attending hand surgeon contact

+46 (0) 186171544

elias.gardell@uu.se

Sweden1 site, 1 recruiting

  • Department of Handsurgery, Uppsala University Hospital

    Uppsala

    Elias Gardell, MD, attending hand surgeon, +46(0) 186171544, elias.gardell@uu.se

    Sara Edsfeldt, MD, PhD, senior attending, +46 (0) 186119031, sara.edsfeldt@uu.se

    Recruiting

Other trials in Sweden

About this study

Official title: BASTION - BASe of Thumb Osteoarthritis Management Non-inferiority Trial: Surgical Treatment of First Carpometacarpal Joint Osteoarthritis: A Comparison Between Joint Replacement and Trapeziectomy

The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis.

The main questions it aims to answer are:

Read more

Does surgery with total joint arthroplasty provide better power grip and pinch grip strength compared to traditional surgery?

What is the long-term risk of complications for both methods?

Which method is more cost-effective for the healthcare system?

Researchers will compare total joint arthroplasty (TOUCH) to trapezectomy (a procedure where a bone in the thumb base is removed) to see which method provides the best results for the patient.

Participants will:

Be randomized to undergo either an operation with total joint arthroplasty or a trapezectomy.

Undergo an initial evaluation and a health economic cost analysis after one year.

Attend follow-up checkups at 2, 5, and 10 years post-surgery to evaluate long-term function and the durability of the prosthesis.

Read the detailed description

Background and Rationale:

Basal joint arthritis of the thumb (trapeziometacarpal osteoarthritis) is a common condition causing pain and reduced hand function. While trapeziectomy with ligament reconstruction/capsuloplasty has long been a gold standard, total joint arthroplasty, such as the TOUCH prosthesis, has gained popularity. However, there is a lack of high-quality prospective randomized controlled trials (RCTs) comparing these methods regarding long-term functional outcomes, complication rates, and cost-effectiveness. This study aims to compare the clinical and health-economic outcomes of total joint arthroplasty with TOUCH prosthesis versus trapeziectomy with capsuloplasty.

Study Design and Randomization:

This is a prospective, randomized controlled trial. Following informed consent obtained by the attending surgeon, participants are randomized to either:

  1. Total joint arthroplasty using the TOUCH prosthesis.
  2. Trapeziectomy with capsuloplasty. Randomization is performed in close proximity to the day of surgery. Due to the nature of the interventions, participants are informed of the surgical method postoperatively.

Procedures and Follow-up

  • Surgical Intervention: Both procedures are performed according to standardized institutional protocols.
  • Postoperative Care (Trapeziectomy): The thumb is immobilized in a cast for 3 weeks, followed by a standardized rehabilitation program led by occupational and physical therapists.
  • Postoperative Care (total joint arthroplasty): A stable soft dressing is applied for 3 weeks, followed by the same rehabilitation protocol.
  • Follow-up Schedule: Participants are evaluated at 3 weeks, 6 weeks, 12 weeks, 12 months, 24 months, 5 years, and 10 years postoperatively.
  • Imaging: Radiographic evaluations are performed for the prosthesis group at 6 weeks, 12 months, 24 months, 5 years, and 10 years to monitor for prosthesis loosening or "z-deformity" (MCP joint hyperextension) compared to the trapeziectomy group.

Data Management and Quality Assurance:

Data is collected and managed using REDCap (Research Electronic Data Capture) to ensure data integrity and validation. Physical informed consent forms are stored securely at the Department of Hand Surgery. Source data verification is performed by comparing registry data against electronic medical records and paper-based Case Report Forms (CRFs).

Sample Size and Power Calculation:

The primary outcome is Jamar grip strength at 12 months. Based on a Minimal Clinically Important Difference (MCID) of 6.5 kg and a standard deviation (SD) of 8.5 kg (derived from existing literature and pilot data), a power calculation (90% power, alpha 0.05, two-sided t-test) determined a requirement of 37 patients per group. To account for a 10% dropout rate, the total cohort size is set at 84 patients (42 per arm).

Health Economic Analysis:

A comprehensive health economic evaluation will be conducted to compare the total costs of both methods. This analysis includes:

  • Direct Costs: Implant costs, anesthesia, surgical time, and healthcare utilization (number of visits).
  • Indirect Costs: Duration of sick leave and time to return to work.
  • Secondary Metrics: Analgesic consumption (paracetamol and opioids), patient-reported quality of life (EQ-5D), and "pain-free days" based on NRS (Numerical Rating Scale) assessments.

The objective is to determine if the higher initial cost of the TOUCH prosthesis is offset by faster recovery, reduced sick leave, and improved long-term productivity.

Being tested
Implantation of trapeziometacarpal prosthesis, Trapeziectomy with Capsuloplasty
Keywords
Thumb base arthroplasty, CMC joint, prosthesis, hand surgery, First Carpometacarpal Joint, Trapeziometacarpal Joint, Rhizarthrosis, Thumb Osteoarthritis, Dual Mobility Prosthesis, Total Joint Replacement, Total Joint Arthroplasty, Ligament Reconstruction, Surgical Reconstruction, Randomized Controlled Trial (RCT), Prospective Studies, Comparative Study, Prospective Study, Cost-Effectiveness Analysis, Cost-Benefit Analysis, Health Economics
Medical subject headings
Capillary Malformations, Congenital, 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation of trapeziometacarpal prosthesisDevice

    Also called TOUCH Dual-Mobility Prosthesis

    Surgical implantation of the TOUCH trapeziometacarpal total joint prosthesis (Kerimedical). The prosthesis consists of an uncemented stainless steel stem inserted into the first metacarpal and a dual cup mobility system with a polyethylene ball articulating against a metal cup fixed in the trapezium. The stem is available in straight or 15-degree angled neck configurations. Postoperative management consists of a stable soft dressing for 3 weeks to allow early controlled mobilization, followed by a standardized hand therapy rehabilitation protocol.

  • Trapeziectomy with CapsuloplastyProcedure or surgery

    Surgical excision of the trapezium bone (trapeziectomy) followed by capsuloplasty using a distally based dorsal capsular flap, without tendon interposition. The capsular flap is sutured to stabilize the base of the first metacarpal. No implant or tendon graft is used. Postoperatively, a cast immobilizing the thumb in functional position is applied for 3 weeks, followed by a standardized hand therapy rehabilitation protocol.

Study groups in NCT07569549
Study groupRoleWhat they receive
Arm 1 -Dual Mobility Prosthesis (TOUCH)ExperimentalTOUCH Total Joint Arthroplasty (n=42). Implantation of TOUCH trapeziometacarpal prosthesis (Kerimedical). Soft bandage for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
Receives: Device: Implantation of trapeziometacarpal prosthesis
Arm 2 - Trapeziectomy and Capsular ReconstructionActive comparatorTrapezectomy with capsuloplasty (n=42). Excision of trapezium with dorsal capsule flap capsuloplasty. Cast immobilization for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
Receives: Procedure: Trapeziectomy with Capsuloplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hand grip strength

    Hand grip strength (JAMAR dynamometer) at 12 months post operatively

    Measured: Measured at 12 months postoperatively

Secondary outcomes (10)

  1. Key-pinch grip strength

    Key-pinch strength measured by pinch-gauge in kilograms

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  2. Pinch grip strength

    3-finger pinch strength measured by pinch gauge in kilograms

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  3. Postoperative Pain Intensity on a Numeric Rating Scale (NRS)

    Pain measured with the Numerical Rating Scale (NRS) at rest and load, where 0 is "no pain" and 10 is "worst imaginable pain"

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  4. Range of movement

    Range of movement of thumb measured by physiotherapist. Extension, flexion, volar abduction, radial abduction. In degrees.

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  5. Metacarpophalangeal (MCP)-joint hyperextension

    Radiographic MCP-joint hyperextension (Z-deformity)

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  6. Complications

    Complications, such as trigger thumb, de Quervain's, reoperation, and infection, reported within 12 months of surgery.

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  7. Use of analgesics

    Total usage of analgesic during the post operative period.

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  8. Duration of sick leave

    Total duration of sick leave.

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  9. Patient-reported outcomes EQ-5D

    Patient-reported outcome of the hand surgery using validated questionnaire EQ-5D

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

  10. Patient-reported outcomes PRWHE

    Patient-reported outcome of the hand surgery using validated questionnaire PRWHE

    Measured: Measured at 6 weeks, 12 weeks, 12 months, 2 years, 5 years and 10 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start4 Sep 2026
  3. Primary completionMay 2030 (estimated)
  4. Study completionMar 2038 (estimated)

Resources

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
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569549
Sponsor's protocol ID
Dnr2026-00547-01
Other IDs
2026-00547-01
Acronym
BASTION
Status last verified
Oct 2026
First submitted
27 Apr 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available to researchers who provide a methodologically sound proposal. Data will be available beginning 6 months and ending 5 years after publication. Requests should be directed to Central contact person. To gain access, data requestors will need to sign a data access agreement and provide proof of approval from the Swedish Ethical Review Authority.

Publications

  • Werle S, Goldhahn J, Drerup S, Simmen BR, Sprott H, Herren DB. Age- and gender-specific normative data of grip and pinch strength in a healthy adult Swiss population. J Hand Surg Eur Vol. 2009 Feb;34(1):76-84. doi: 10.1177/1753193408096763. Epub 2009 Jan 7.

    PubMed 19129352

  • Kim JK, Park MG, Shin SJ. What is the minimum clinically important difference in grip strength? Clin Orthop Relat Res. 2014 Aug;472(8):2536-41. doi: 10.1007/s11999-014-3666-y. Epub 2014 May 10.

    PubMed 24817380

  • Lang CE, Edwards DF, Birkenmeier RL, Dromerick AW. Estimating minimal clinically important differences of upper-extremity measures early after stroke. Arch Phys Med Rehabil. 2008 Sep;89(9):1693-700. doi: 10.1016/j.apmr.2008.02.022.

    PubMed 18760153

  • Kierkegaard M, Petitclerc E, Hebert LJ, Mathieu J, Gagnon C. Responsiveness of performance-based outcome measures for mobility, balance, muscle strength and manual dexterity in adults with myotonic dystrophy type 1. J Rehabil Med. 2018 Feb 28;50(3):269-277. doi: 10.2340/16501977-2304.

    PubMed 29260836

  • Draak TH, Pruppers MH, van Nes SI, Vanhoutte EK, Bakkers M, Gorson KC, Van der Pol WL, Lewis RA, Notermans NC, Nobile-Orazio E, Leger JM, Van den Bergh PY, Lauria G, Bril V, Katzberg H, Lunn MP, Pouget J, van der Kooi AJ, van den Berg LH, van Doorn PA, Cornblath DR, Hahn AF, Faber CG, Merkies IS; PeriNomS study group. Grip strength comparison in immune-mediated neuropathies: Vigorimeter vs. Jamar. J Peripher Nerv Syst. 2015 Sep;20(3):269-76. doi: 10.1111/jns.12126.

    PubMed 26115516

  • Bohannon RW. Minimal clinically important difference for grip strength: a systematic review. J Phys Ther Sci. 2019 Jan;31(1):75-78. doi: 10.1589/jpts.31.75. Epub 2019 Jan 10.

    PubMed 30774209

  • Herren DB, Marks M, Neumeister S, Schindele S. Low complication rate and high implant survival at 2 years after Touch(R) trapeziometacarpal joint arthroplasty. J Hand Surg Eur Vol. 2023 Oct;48(9):877-883. doi: 10.1177/17531934231179581. Epub 2023 Jun 13.

    PubMed 37310049

  • Kriegs-Au G, Petje G, Fojtl E, Ganger R, Zachs I. Ligament reconstruction with or without tendon interposition to treat primary thumb carpometacarpal osteoarthritis. A prospective randomized study. J Bone Joint Surg Am. 2004 Feb;86(2):209-18. doi: 10.2106/00004623-200402000-00001.

    PubMed 14960663

  • Guzzini M, Arioli L, Annibaldi A, Pecchia S, Latini F, Ferretti A. Interposition Arthroplasty versus Dual Cup Mobility Prosthesis in Treatment of Trapeziometacarpal Joint Osteoarthritis: A Prospective Randomized Study. Hand (N Y). 2024 Nov;19(8):1260-1268. doi: 10.1177/15589447231185584. Epub 2023 Jul 23.

    PubMed 37482747

  • Newton A, Talwalkar S. Arthroplasty in thumb trapeziometacarpal (CMC joint) osteoarthritis: An alternative to excision arthroplasty. J Orthop. 2022 Nov 26;35:134-139. doi: 10.1016/j.jor.2022.11.011. eCollection 2023 Jan.

    PubMed 36471695

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of trapeziometacarpal prosthesis and Trapeziectomy with Capsuloplasty in people with Thumb Osteoarthritis and Thumb Carpometacarpal Joint Osteoarthritis, run by Uppsala University 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 6 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?

Contact Eva Nordin, Clinical research nurse (+46(0) 186119630, eva.nordin@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hand grip strength (time frame: Measured at 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07569549, which also lists 10 linked publications.

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 9 Oct 2026.

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