Trapeziometacarpal Osteoarthritis
Conditions
Keywords
TMC OA
Brief summary
The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis. The main question this study aims to address is : \- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function. Participant will: * Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0 * Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.
Interventions
PROCEDUREwith SclerFIX
Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
Sponsors
TBF Genie Tissulaire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient presenting with symptomatic osteoarthritis of the trapeziometacarpal joint, with wrist pain ≥ 40/100 according to the PRWE pain subscale (scaled to 100). * Patient who has received medical treatment for functional symptoms for more than 3 months without improvement, and for whom surgical intervention is indicated. * Patient with radiographic stage I-II trapeziometacarpal joint osteoarthritis according to the Eaton-Glickel classification. * Patient able to understand, date, and sign the informed consent form. * Patient affiliated with a social security system or beneficiary of such a system.
Exclusion criteria
* Pregnant or breastfeeding woman ; woman without effective contraception. * Patient with scaphotrapeziotrapezoid (STT) joint osteoarthritis requiring prosthetic surgical treatment. * Patient with thumb osteoarthritis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis). * Patient with osteoarthritis experiencing an acute inflammatory flare, characterized by a warm, painful, and swollen joint at the time of enrollment. * Patient with amputated hand(s). * Patient presenting signs of neuropathy with functional impairment such as hyperesthesia. Neuropathy may be peripheral (nerve injury) or systemic (caused by diabetes or excessive alcohol consumption). * Patient lacking capacity to participate in rehabilitation or to comply with study follow-up. * Patient with a contraindication to anesthesia (poorly controlled epilepsy, neuropathy, etc.). * Person deprived of liberty by a judicial or administrative decision. * Adult subject under legal protection or unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. | Enrollment, 12 months | Thumb osteoarthritis-related pain will be assessed using the PRWE (Patient-Rated Wrist Evaluation) pain subscale and expressed as a percentage. The use of oral analgesics for hand pain will also be recorded at each follow-up visit, based on the preceding 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in thumb mobility between the baseline and the post-operative visits. | Enrollment, 3 months, 6 months and 12 months | Thumb mobility will be determined by the active range of motion of the TMC joint and by the active thumb opposition. Active range of motion of the TMC joint will be measured using goniometer. Active thumb opposition will be assessed according to the Kapandji score. |
| Change in the strength of the thumb between the baseline and the post-operative visits. | Enrollment, 3 months, 6 months, 12 months | Pinch strength will be measured using a pinch gauge. |
| Change in the strength of the hand between the baseline and the post-operative visits. | Enrollment, 3 months, 6 months, 12 months | Grip strength will be measured using a hand dynamometer. |
| Change in the daily functionality of the wrist between the baseline and the post-operative visits. | Enrollment, 3 months, 6 months, 12 months | Daily functionality of the wrist will be assessed using the PRWE (Patient-Rated Wrist Evaluation) function subscale and expressed as a percentage. |
| Change in the stage of the trapeziometacarpal osteoarthritis between the baseline and the 12-months post-operative visit | Enrollment, 12 months | The stage of TMC osteoarthritis will be determined, according to the Eaton-Glickel classication, on radiological images of the wrist. |
| Frequency of occurence of post-surgical complications and implant-related tolerance events | From Surgery to the end of the study at 12 months post-operative | Determination of the frequency of occurrence of post-surgical complications and implant-related tolerance events throughout the study. |
Outcome results
None listed