SclerFIX-IP
BiologicalDecellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
NCT Number: NCT06038331
The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of STT osteoarthritis.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
CHU de Besançon, Besançon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
Time frame: 12 months
Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit
Time frame: Through study completion (12 months)
No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
Time frame: 1 month, 3 months, 6 months, 12 months
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months
Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
Time frame: 3 months, 6 months, 12 months
Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Time frame: 3 months, 6 months, 12 months
Grip strength measured in kg by grip strength test using a dynamometer
Time frame: 12 months
Joint space evaluated on radiography using Crosby's classification
Contact information is provided by the study sponsor or research team.
Justine BOSC, MSc
CONTACT
4 72 68 69 11 ext. +33
Laurence BARNOUIN, MD
CONTACT
4 72 68 69 09 ext. +33
TBF Genie Tissulaire
Industry
Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
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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.
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