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Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis, Focusing on Changes in Pain (Measured With the VAS Scale) and Function (With the Quick-DASH).

RecruitingNAAges any - anyAllParc de Salut Mar
NCT07101887 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Rizarthrosis grade I, II, III Exclusion Criteria: * Rizarthrosis grade IV * Severe osteoporosis * Metals allergy * Previous surgical interventions related * Malformations in the articular zones that difficult the implant placement
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What it tests

  • Implantation of thumb prosthesis
  • Burton-Pellegrini technique
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Where

1 site
Hospital del Mar
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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