Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial

Lirola-Palmero, Serafín; Salva-Coll, Guillem; Yáñez-Juan, Aina María; Sánchez Iriso, Eduardo

Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial

dc.contributor.author	Lirola-Palmero, Serafín
dc.contributor.author	Salva-Coll, Guillem
dc.contributor.author	Yáñez-Juan, Aina María
dc.contributor.author	Sánchez Iriso, Eduardo
dc.contributor.department	Economía	es_ES
dc.contributor.department	Ekonomia	eu
dc.date.accessioned	2024-08-13T16:18:13Z
dc.date.available	2024-08-13T16:18:13Z
dc.date.issued	2024
dc.date.updated	2024-08-13T15:48:59Z
dc.description.abstract	Background: Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction. Methods: A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis. Patients, 18 years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfll the trial’s eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests. A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Maïa® prosthesis. The participants will complete diferent questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6 weeks, and 3, 6, 12, 24, 36, 48, and 60 months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial’s primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12 months. A long-term follow-up analysis will be performed every year for 5 years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider’s and society perspective using direct and indirect medical costs. Discussion: This is the frst randomized study that investigates the efectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Maïa prosthesis. We expect the fndings from this trial to lead to new insights into the surgical approach to TMC OA. Trial registration: ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.	en
dc.description.sponsorship	This study is funded by grants from the Orthopaedic Spanish Society Foundation (SECOT). The trial sponsor is Hospital Son Espases, Palma de Mallorca. The funders and the sponsor of the study are neither involved in the study design nor the interpretation of data nor the publication of the results.
dc.format.mimetype	application/pdf	en
dc.identifier.citation	Lirola-Palmero, S., Salva-Coll, G., Yáñez-Juan, A. M., Sánchez-Iriso, E. (2024) Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial. Trials, 25(1), 1-9. https://doi.org/10.1186/s13063-024-08057-1.
dc.identifier.doi	10.1186/s13063-024-08057-1
dc.identifier.issn	1745-6215
dc.identifier.uri	https://academica-e.unavarra.es/handle/2454/50708
dc.language.iso	eng
dc.publisher	BMC
dc.relation.ispartof	Trials (2024), 25:220
dc.relation.publisherversion	https://doi.org/10.1186/s13063-024-08057-1
dc.rights	© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License
dc.rights.accessRights	info:eu-repo/semantics/openAccess
dc.rights.uri	https://creativecommons.org/licenses/by/4.0/
dc.subject	Arthroplasty	en
dc.subject	Ball-and-socket prosthesis	en
dc.subject	Osteoarthritis	en
dc.subject	Trapeziectomy	en
dc.subject	Trapeziometacarpal	en
dc.title	Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial	en
dc.type	info:eu-repo/semantics/article
dc.type.version	info:eu-repo/semantics/publishedVersion
dspace.entity.type	Publication
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