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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy (BASTION)

22 juni 2026 bijgewerkt door: Uppsala University

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:

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

84

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Elias Gardell, MD, attending hand surgeon
  • Telefoonnummer: +46 (0) 186171544
  • E-mail: elias.gardell@uu.se

Studie Locaties

  • Zweden
      • Uppsala, Zweden
        • Werving
        • Department of Handsurgery, Uppsala University Hospital
        • Contact:
          • Elias Gardell, MD, attending hand surgeon
          • Telefoonnummer: +46(0) 186171544
          • E-mail: elias.gardell@uu.se
        • Contact:
          • Sara Edsfeldt, MD, PhD, senior attending
          • Telefoonnummer: +46 (0) 186119031
          • E-mail: sara.edsfeldt@uu.se
        • Hoofdonderzoeker:
          • Sara Edsfeldt, MD, PhD, senior attending
      • Örebro, Zweden
        • Nog niet aan het werven
        • Örebro University Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Eva Lundqvist, MD, PhD, senior attending

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm 1 -Dual Mobility Prosthesis (TOUCH)
TOUCH Total Joint Arthroplasty (n=42). Implantation of TOUCH trapeziometacarpal prosthesis (Kerimedical). Soft bandage for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
Apparaat: Implantation of trapeziometacarpal 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.
Andere namen:
  • TOUCH Dual-Mobility Prosthesis
Actieve vergelijker: Arm 2 - Trapeziectomy and Capsular Reconstruction
Trapezectomy with capsuloplasty (n=42). Excision of trapezium with dorsal capsule flap capsuloplasty. Cast immobilization for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
Procedure: Trapeziectomy with Capsuloplasty
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hand grip strength
Tijdsspanne: Measured at 12 months postoperatively
Hand grip strength (JAMAR dynamometer) at 12 months post operatively
Measured at 12 months postoperatively

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Key-pinch grip strength
Tijdsspanne: Measured at 6 weeks, 12 weeks, and 12 months postoperatively
Key-pinch strength measured by pinch-gauge in kilograms
Measured at 6 weeks, 12 weeks, and 12 months postoperatively
Pinch grip strength
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
3-finger pinch strength measured by pinch gauge in kilograms
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Postoperative Pain Intensity on a Numeric Rating Scale (NRS)
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Pain measured with the Numerical Rating Scale (NRS) at rest and load, where 0 is "no pain" and 10 is "worst imaginable pain"
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Range of movement
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Range of movement of thumb measured by physiotherapist. Extension, flexion, volar abduction, radial abduction. In degrees.
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Metacarpophalangeal (MCP)-joint hyperextension
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Radiographic MCP-joint hyperextension (Z-deformity)
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Complications
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Complications, such as trigger thumb, de Quervain's, reoperation, and infection, reported within 12 months of surgery.
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Use of analgesics
Tijdsspanne: Measured at 12 months postoperatively
Total usage of analgesic during the post operative period.
Measured at 12 months postoperatively
Duration of sick leave
Tijdsspanne: Measured at 12 months postoperatively
Total duration of sick leave.
Measured at 12 months postoperatively
Patient-reported outcomes EQ-5D
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire EQ-5D
Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcomes PRWHE
Tijdsspanne: Measured at 6 weeks, 12 weeks and 12 months postoperatively
Patient-reported outcome of the hand surgery using validated questionnaire PRWHE
Measured at 6 weeks, 12 weeks and 12 months postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Uppsala University

Medewerkers

Örebro County Council
Uppsala County Council, Sweden

Onderzoekers

  • Studie directeur: Nils Hailer, MD, PhD. Professor, Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
  • Hoofdonderzoeker: Sara Edsfeldt, MD, PhD, senior attending, Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden
  • Studie stoel: Sara Edsfeldt, MD, PhD, senior attending, Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 mei 2030

Studie voltooiing (Geschat)

1 maart 2038

Studieregistratiedata

Eerst ingediend

27 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

6 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Dnr2026-00547-01
  • 2026-00547-01 (Andere identificatie: Swedish Ethical Review Authority)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Beginning 6 months and ending 5 years after publication

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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