Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
BASTION
BASTION - BASe of Thumb Osteoarthritis Management Non-inferiority Trial: Surgical Treatment of First Carpometacarpal Joint Osteoarthritis: A Comparison Between Joint Replacement and Trapeziectomy
2 other identifiers
interventional
84
1 country
2
Brief 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. The main questions it aims to answer are: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2038
May 6, 2026
May 1, 2026
4 years
April 27, 2026
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hand grip strength
Hand grip strength (JAMAR dynamometer) at 12 months post operatively
Measured at 12 months postoperatively
Secondary Outcomes (13)
Key-pinch grip strength
Measured at 6 weeks, 12 weeks, and 12 months postoperatively
Pinch grip strength
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Postoperative Pain Intensity on a Numeric Rating Scale (NRS)
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Range of movement
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Metacarpophalangeal (MCP)-joint hyperextension
Measured at 6 weeks, 12 weeks and 12 months postoperatively
- +8 more secondary outcomes
Study Arms (2)
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.
Arm 2 - Trapeziectomy and Capsular Reconstruction
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous surgery to thumb base or STT-joint
- Ongoing chronic pain condition
- Dementia or cognitive impairment
- Trapezium height \<7 mm on plain radiograph
- Active smoker
- Osteoarthritis grade 4 (Eaton-Littler)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Uppsala County Council, Swedencollaborator
- Örebro County Councilcollaborator
Study Sites (2)
Örebro university hospital
Örebro, Sweden
Department of Handsurgery, Uppsala University Hospital
Uppsala, Sweden
Related Publications (10)
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.
PMID: 19129352BACKGROUNDKim 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.
PMID: 24817380BACKGROUNDLang 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.
PMID: 18760153BACKGROUNDKierkegaard 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.
PMID: 29260836BACKGROUNDDraak 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.
PMID: 26115516BACKGROUNDBohannon 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.
PMID: 30774209BACKGROUNDHerren 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.
PMID: 37310049BACKGROUNDKriegs-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.
PMID: 14960663BACKGROUNDGuzzini 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.
PMID: 37482747BACKGROUNDNewton 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.
PMID: 36471695BACKGROUND
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Nils Hailer, MD, PhD. Professor
Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
- PRINCIPAL INVESTIGATOR
Sara Edsfeldt, MD, PhD, senior attending
Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
- STUDY CHAIR
Sara Edsfeldt, MD, PhD, senior attending
Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2026
First Posted
May 6, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
March 1, 2038
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Beginning 6 months and ending 5 years after publication
- Access Criteria
- Access will be granted to qualified academic researchers who provide a methodologically sound scientific proposal. The request must be consistent with the informed consent provided by the participants. Access requires a formal Data Sharing Agreement (DSA) and a valid ethical approval from the Swedish Ethical Review Authority (Etikprövningsmyndigheten). The requesting party must also demonstrate that they have the necessary infrastructure to handle sensitive data according to GDPR
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.