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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00810-49 | Other Identifier | IDRCB |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SclerFIX | Experimental | Treated amniotic membrane of umbilical cord allograft |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| with SclerFIX | Procedure | Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in thumb osteoarthritis-related pain between the baseline and the the 12-month end-of-study visit. | 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. | Enrollment, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in thumb mobility between the baseline and the post-operative visits. | 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. | Enrollment, 3 months, 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Change in the strength of the thumb between the baseline and the post-operative visits. | Pinch strength will be measured using a pinch gauge. | Enrollment, 3 months, 6 months, 12 months |
| Change in the strength of the hand between the baseline and the post-operative visits. | Grip strength will be measured using a hand dynamometer. | Enrollment, 3 months, 6 months, 12 months |
| Change in the daily functionality of the wrist between the baseline and the post-operative visits. | Daily functionality of the wrist will be assessed using the PRWE (Patient-Rated Wrist Evaluation) function subscale and expressed as a percentage. | Enrollment, 3 months, 6 months, 12 months |
| Change in the stage of the trapeziometacarpal osteoarthritis between the baseline and the 12-months post-operative visit | The stage of TMC osteoarthritis will be determined, according to the Eaton-Glickel classication, on radiological images of the wrist. | Enrollment, 12 months |
| Frequency of occurence of post-surgical complications and implant-related tolerance events | Determination of the frequency of occurrence of post-surgical complications and implant-related tolerance events throughout the study. | From Surgery to the end of the study at 12 months post-operative |