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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
Isolated trapeziometacarpal arthroplasty with double mobility
Procedure/SurgeryIsolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits.
Treatment groups
Trial 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.
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
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)
Radiographic evaluation
Radiographic evaluation: absence of prosthesis complications
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).
Sponsors and contacts
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