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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolated trapeziometacarpal arthroplasty | Experimental | Isolated TM arthroplasty with double mobility in all cases, using a MAIA (Laboratoire LEPINE) or TOUCH (Laboratoire KERIMEDICAL) prosthesis, depending on the surgeons' habits. Participating surgeons will follow a common operating protocol to ensure consistency of procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isolated trapeziometacarpal arthroplasty with double mobility | Procedure | Isolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months, 6 months and 12 months post-operative |
| Complication or surgery |
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Inclusion Criteria:- Patients over 18 years of age who are members or beneficiaries of french social security
TM osteoarthritis: glickel sign + grinding test STT osteoarthritis: pain on wrist mobilization in flexion-extension and prono-supination
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecile Spirito | Contact | 0033467413399 | cecile.spirito@capsante.fr |
| Name | Affiliation | Role |
|---|---|---|
| benjamin Degeorge | Clinique Saint jean sud de france | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique St jean sud de france | Recruiting | Montpellier | 34430 | France |
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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) |
| One year |
| Radiographic evaluation | Radiographic evaluation: absence of prosthesis complications | 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). | 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. | 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 | 3 months, 6 months and 12 months postoperatively |
| Wrist range of motion | Wrist range of motion: flexion, extension, radial tilt and ulnar tilt preoperatively, at 3 months, 6 months and 12 months postoperatively | 3 months, 6 months and 12 months postoperatively |
| Amplitude of possible metacarpophalangeal hyperextension | Amplitude of possible metacarpophalangeal hyperextension preoperatively at 3 months, 6 months and 12 months postoperatively | preoperatively at 3 months, 6 months and 12 months postoperatively |