Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint Jean, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age who are members or beneficiaries of french social security

Patient requiring surgical management

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)

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Isolated trapeziometacarpal arthroplasty with double mobility

    Procedure/Surgery

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Isolated trapeziometacarpal arthroplastyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

Radiographic evaluation

Radiographic evaluation: absence of prosthesis complications

Time frame
one year
4

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

Other outcomes

Sponsors and contacts

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