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).
Recruiting · NCT07101887 · Interventional (participants receive a specific treatment) · Lead sponsor: Parc de Salut Mar
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
1 location listed.
- Hospital del Mar - Barcelona, Spain