with SclerFIX
ProcedureUse of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
NCT Number: NCT07435571
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint
Time frame: 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.
Time frame: 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.
Time frame: Enrollment, 3 months, 6 months, 12 months
Pinch strength will be measured using a pinch gauge.
Time frame: Enrollment, 3 months, 6 months, 12 months
Grip strength will be measured using a hand dynamometer.
Time frame: 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.
Time frame: Enrollment, 12 months
The stage of TMC osteoarthritis will be determined, according to the Eaton-Glickel classication, on radiological images of the wrist.
Time frame: 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.
TBF Genie Tissulaire
Industry
Evaluation of the Treatment of Trapeziometacarpal Osteoarthritis (TMC OA) With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07668986
Trapeziometacarpal Osteoarthritis
Málaga, Spain
View Trial DetailsNCT07458971
Carpometacarpal Osteoarthritis, Thumb Basal Joint Osteoarthritis
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07421089
Trapeziometacarpal Osteoarthritis
Málaga, Spain
View Trial DetailsNCT07447323
Neurologic Manifestations, Pain
Ankara, Turkey (Türkiye)
View Trial Details