Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
Study Details
Study Description
Brief Summary
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 PIP joint osteoarthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SclerFIX-IP Treated, devitalised and sterile graft of umbilical cord amniotic membrane |
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 PIPJ
|
Outcome Measures
Primary Outcome Measures
- Change in the symptomatology related to the PIPJ OA [12 months]
Quality of life related to PIPJ 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
Secondary Outcome Measures
- Absence of toxicity [Through study completion (12 months)]
No inflammatory reactions, no adverse events
- Change in pain related to PIPJ OA [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)
- Change in the treated finger mobility [3 months, 6 months, 12 months]
Change from baseline (CFB) in degree of active and passive flexion and extension of the finger treated in the study
- No apparent joint space anomaly [12 months]
Joint space evaluated on radiography using Crosby's classification (stage 0 = no apparent anormaly; stage 1 = reduction to half of the normal joint space; stage 2 = hardly visible articular line; stage 3 = presence of erosions, scleroses and irregularity of the articular interline space)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female; age between 18 and 75 years.
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Patient with symptomatic PIPJ OA.
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Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
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Patient with a QuickDash score > 33 points (converted to 50%).
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Patient with pain, at rest, in the PIPJ ≥ 4/10 on a VAS.
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Patient who received the study information and provided consent.
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Member or beneficiary of a national health insurance plan.
Exclusion Criteria:
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Pregnant or breastfeeding woman; woman without effective contraception.
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Patient with signs of neuropathy with functional disorders such as hyperesthesia.
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Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
-
Person confined by a judicial or administrative decision.
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Adult subjected to legal protection measures or unable to provide his/her consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Chirurgical de la Main et du Membre Supérieur | Lyon | France | 69006 |
Sponsors and Collaborators
- TBF Genie Tissulaire
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SclerFIX-IPP-TBF