Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

Clinique Saint Jean, France300 enrolled

Overview

The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms. The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively. The study design is a follow-up study of a multicenter cohort.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Trapeziometacarpal Osteoarthritis

Interventions

Isolated trapeziometacarpal arthroplasty with double mobilityPROCEDURE

Isolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria:- Patients over 18 years of age who are members or beneficiaries of french social security * Patient requiring surgical management * Clinical and radiographic diagnosis of peri-trapezial osteoarthritis in the 1 or 2 joints: TM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination * TM (Eaton-Littler stages II to III) and STT (Crosby stages II and III) radiographic osteoarthritis * Persistent pain and functional limitations despite conservative treatment for at least 6 months (combining intermittent immobilization of wrist and thumb + joint infiltration of the 2 joints) * Ability to understand and sign the informed consent form. Exclusion Criteria: * History of surgery on the affected thumb. * Systemic inflammatory diseases (e.g. rheumatoid arthritis). * Active infection or history of joint infection of the upper limb. * Inability to participate in post-operative follow-up.

Locations (1)

Clinique St jean sud de france

Montpellier, France

RECRUITING

Outcomes

Primary Outcomes

Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score

Change in Quick DASH functional score between inclusion (preoperative) and one year postoperatively, from 0 = no disability to 100 = maximum disability.

Time frame: One year

Secondary Outcomes

Patient satisfaction

Likert satisfaction scale at 3 months, 6 months and 12 months post-operative. Chossing between very satisfied , Satisfied , No opinion , Dissatisfied or Very dissatisfied

Time frame: 3 months, 6 months and 12 months post-operative

Complication or surgery

Need for repeat surgery and any post-operative complication during 12-month follow-up. Need for additional surgery on STT joint (= if pain on palpation and flexion/extension mobilization)

Time frame: One year

Radiographic evaluation

Radiographic evaluation: absence of prosthesis complications

Time frame: one year

Pain in the operated hand

Visual Analogue Scale (VAS) for pain preoperatively at 3 months, 6 months and 12 months postoperatively, from 0 (no pain) to 10 (maximum pain).

Time frame: 3 months, 6 months and 12 months postoperatively

Pinch and grip force

Pinch and grip force measured with dynamometer preoperatively, at 3 months, 6 months and 12 months postoperatively.

Time frame: 3 months, 6 months and 12 months postoperatively

Range of motion of the thumb

Range of motion of the thumb measured relative to the 2nd metacarpal: antepulsion, retropulsion, abduction and adduction preoperatively, at 3 months, 6 months and 12 months postoperatively

Central Contacts

Cecile Spirito

CONTACT

0033467413399 cecile.spirito@capsante.fr

Data from ClinicalTrials.gov

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