About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Rizarthrosis grade I, II, III
Disqualifiers
Rizarthrosis grade IV
Severe osteoporosis
Metals allergy
Previous surgical interventions related
Trial design
Parallel
Treatments tested in this trial
Implantation of thumb prosthesis
Procedure/SurgeryReplacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis.
Burton-Pellegrini technique
Procedure/SurgeryRemove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon
Treatment groups
Trial outcomes
Primary outcomes
VAS
Pain evaluated by Visual analogic scale (VAS)
Quick Dash
Function of the arm evaluated by Quick Dash scale
Secondary outcomes
Strength
Strength evaluated with a pressure gauge
Sponsors and contacts
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