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).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of thumb prosthesis, Burton-Pellegrini technique.
- Who it may be relevant to
- Registry conditions: Rizarthrosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.
Overview
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).
Interventions
- Procedure Implantation of thumb prosthesis
Replacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis. - Procedure Burton-Pellegrini technique
Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon
Primary outcome measures
- VAS [Time frame: 1 year]
- Quick Dash [Time frame: 1 year]
Secondary outcome measures (1)
- Strength [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital del Mar — Barcelona
Identifiers
NCT: NCT07101887 · 2019/8942/I