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).

ConditionRizarthrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorParc de Salut Mar

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 volunteers

Qualifiers

Rizarthrosis grade I, II, III

Disqualifiers

Rizarthrosis grade IV

Severe osteoporosis

Metals allergy

Previous surgical interventions related

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implantation of thumb prosthesis

    Procedure/Surgery

    Replacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis.

  • Burton-Pellegrini technique

    Procedure/Surgery

    Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon

Treatment groups

61 Participants
are divided into 2 treatment groups
Group A: Maia Prosthesis groupExperimental treatment 1 intervention
Group B: Trapeziectomy and Burton-Pellegrini techniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

VAS

Pain evaluated by Visual analogic scale (VAS)

Time frame
1 year
2

Quick Dash

Function of the arm evaluated by Quick Dash scale

Time frame
1 year

Secondary outcomes

1

Strength

Strength evaluated with a pressure gauge

Time frame
1 year

Other outcomes

Sponsors and contacts

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