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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-00547-01 | Other Identifier | Swedish Ethical Review Authority |
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| Name | Class |
|---|---|
| Uppsala County Council, Sweden | OTHER_GOV |
| Örebro County Council | OTHER_GOV |
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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.
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:
Procedures and Follow-up
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 -Dual Mobility Prosthesis (TOUCH) | Experimental | TOUCH Total Joint Arthroplasty (n=42). Implantation of TOUCH trapeziometacarpal prosthesis (Kerimedical). Soft bandage for 3 weeks postoperatively, followed by rehabilitation per national guidelines. |
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| Arm 2 - Trapeziectomy and Capsular Reconstruction | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of trapeziometacarpal prosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hand grip strength | Hand grip strength (JAMAR dynamometer) at 12 months post operatively | Measured at 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Key-pinch grip strength | Key-pinch strength measured by pinch-gauge in kilograms | Measured at 6 weeks, 12 weeks, and 12 months postoperatively |
| Pinch grip strength | 3-finger pinch strength measured by pinch gauge in kilograms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Nils Hailer, MD, PhD. Professor | Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden | Study Director |
| Sara Edsfeldt, MD, PhD, senior attending | Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro university hospital | Not yet recruiting | Örebro | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19129352 | Background | 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. | |
| 24817380 | Background | 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. |
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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.
Beginning 6 months and ending 5 years after publication
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
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| Trapeziectomy with Capsuloplasty | Procedure | 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. |
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| Measured at 6 weeks, 12 weeks and 12 months postoperatively |
| 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 at 6 weeks, 12 weeks and 12 months postoperatively |
| Range of movement | 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 | Radiographic MCP-joint hyperextension (Z-deformity) | Measured at 6 weeks, 12 weeks and 12 months postoperatively |
| Complications | 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 | Total usage of analgesic during the post operative period. | Measured at 12 months postoperatively |
| Duration of sick leave | Total duration of sick leave. | Measured at 12 months postoperatively |
| Patient-reported outcomes EQ-5D | 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 | Patient-reported outcome of the hand surgery using validated questionnaire PRWHE | Measured at 6 weeks, 12 weeks and 12 months postoperatively |
| Sara Edsfeldt, MD, PhD, senior attending | Department of orthopaedics and hand surgery, Akademiska hospital, Uppsala, Sweden | Study Chair |
| Department of Handsurgery, Uppsala University Hospital | Recruiting | Uppsala | Sweden |
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| 18760153 | Background | 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. |
| 29260836 | Background | 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. |
| 26115516 | Background | 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. |
| 30774209 | Background | 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. |
| 37310049 | Background | 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. |
| 14960663 | Background | 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. |
| 37482747 | Background | 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. |
| 36471695 | Background | 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. |
| ID | Term |
|---|---|
| C562760 | Capillary Malformations, Congenital, 1 |
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