Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
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: SclerFIX-IP.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Hand. Basic parameters: 18 years — 75 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
Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
Overview
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.
Interventions
- Biological SclerFIX-IP
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
Primary outcome measures
- Decrease of the symptomatology related to the STT OA [Time frame: 12 months]
Secondary outcome measures (6)
- Absence of inflammatory reactions and good local tolerance of the implant [Time frame: Through study completion (12 months)]
- Decrease of pain related to STT OA [Time frame: 1 month, 3 months, 6 months, 12 months]
- Improvement of functional activities involving the thumb [Time frame: 1 month, 3 months, 6 months, 12 months]
- Increase of thumb strength [Time frame: 3 months, 6 months, 12 months]
- Increase of grip strength [Time frame: 3 months, 6 months, 12 months]
- No apparent joint space anomaly [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Male or female; age between 18 and 75 years.
- Patient with symptomatic STT OA.
- Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
- Patient with a QuickDash score > 33 points (converted to 50%).
- Patient with wrist pain in front of the STT joint at rest = or > 4/10 on VAS.
- Patient who received the study information and provided consent.
- Member or beneficiary of a national health insurance plan.
Exclusion criteria
- Pregnant or breastfeeding woman; woman without effective contraception.
- Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
- Patient with signs of neuropathy with functional disorders such as hyperesthesia.
- Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
- Person confined by a judicial or administrative decision.
- Adult subjected to legal protection measures or unable to provide his/her consent.
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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 4 centers
- CHU de Besançon — Besançon
- Institut Chirurgical de la Main et du Membre Supérieur (ICMMS) — Lyon
- Centre de la Main - Clinique Jules Verne — Nantes
- Hôpitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT06038331 · SclerFIX-STT-TBF · 2023-A00790-45