Trapeziometacarpal Osteoarthritis
Conditions
Brief summary
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.
Interventions
PROCEDUREIsolated trapeziometacarpal arthroplasty with double mobility
Isolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits.
Sponsors
Clinique Saint Jean, France
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score | One year | Change in Quick DASH functional score between inclusion (preoperative) and one year postoperatively, from 0 = no disability to 100 = maximum disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication or surgery | One year | 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 | one year | Radiographic evaluation: absence of prosthesis complications |
| Pain in the operated hand | 3 months, 6 months and 12 months postoperatively | Visual Analogue Scale (VAS) for pain preoperatively at 3 months, 6 months and 12 months postoperatively, from 0 (no pain) to 10 (maximum pain). |
| Patient satisfaction | 3 months, 6 months and 12 months post-operative | Likert satisfaction scale at 3 months, 6 months and 12 months post-operative. Chossing between very satisfied , Satisfied , No opinion , Dissatisfied or Very dissatisfied |
| Range of motion of the thumb | 3 months, 6 months and 12 months postoperatively | 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 |
| Wrist range of motion | 3 months, 6 months and 12 months postoperatively | Wrist range of motion: flexion, extension, radial tilt and ulnar tilt preoperatively, at 3 months, 6 months and 12 months postoperatively |
| Amplitude of possible metacarpophalangeal hyperextension | preoperatively at 3 months, 6 months and 12 months postoperatively | Amplitude of possible metacarpophalangeal hyperextension preoperatively at 3 months, 6 months and 12 months postoperatively |
| Pinch and grip force | 3 months, 6 months and 12 months postoperatively | Pinch and grip force measured with dynamometer preoperatively, at 3 months, 6 months and 12 months postoperatively. |
Countries
France
Contacts
Primary ContactCecile Spirito
Outcome results
None listed