Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Процедура 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.

Первичные конечные точки

• Hand grip strength [Срок оценки: Measured at 12 months postoperatively]

Вторичные конечные точки (10)

• Key-pinch grip strength [Срок оценки: Measured at 6 weeks, 12 weeks, and 12 months postoperatively]
• Pinch grip strength [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]
• Postoperative Pain Intensity on a Numeric Rating Scale (NRS) [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]
• Range of movement [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]
• Metacarpophalangeal (MCP)-joint hyperextension [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]
• Complications [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]
• Use of analgesics [Срок оценки: Measured at 12 months postoperatively]
• Duration of sick leave [Срок оценки: Measured at 12 months postoperatively]
• Patient-reported outcomes EQ-5D [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]
• Patient-reported outcomes PRWHE [Срок оценки: Measured at 6 weeks, 12 weeks and 12 months postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 2 центра

• Örebro university hospital — Örebro
• Department of Handsurgery, Uppsala University Hospital — Uppsala

Публикации

• 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 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 14960663

Идентификаторы

NCT: NCT07569549 · Dnr2026-00547-01 · 2026-00547-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗