Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Isolated trapeziometacarpal arthroplasty with double mobility.
- Who it may be relevant to
- Registry conditions: Trapeziometacarpal Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty
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.
Interventions
- Procedure Isolated 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.
Primary outcome measures
- Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score [Time frame: One year]
Secondary outcome measures (8)
- Patient satisfaction [Time frame: 3 months, 6 months and 12 months post-operative]
- Complication or surgery [Time frame: One year]
- Radiographic evaluation [Time frame: one year]
- Pain in the operated hand [Time frame: 3 months, 6 months and 12 months postoperatively]
- Pinch and grip force [Time frame: 3 months, 6 months and 12 months postoperatively]
- Range of motion of the thumb [Time frame: 3 months, 6 months and 12 months postoperatively]
- Wrist range of motion [Time frame: 3 months, 6 months and 12 months postoperatively]
- Amplitude of possible metacarpophalangeal hyperextension [Time frame: preoperatively at 3 months, 6 months and 12 months postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Clinique St jean sud de france — Montpellier
Identifiers
NCT: NCT07169474 · TM2025