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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
CHU de Besançon
Besançon, France
RECRUITINGInstitut Chirurgical de la Main et du Membre Supérieur (ICMMS)
Lyon, France
RECRUITINGCentre de la Main - Clinique Jules Verne
Nantes, France
RECRUITINGDecrease of the symptomatology related to the STT OA
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: 12 months
Absence of inflammatory reactions and good local tolerance of the implant
No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
Time frame: Through study completion (12 months)
Decrease of pain related to STT OA
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
Improvement of functional activities involving the thumb
Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
Time frame: 1 month, 3 months, 6 months, 12 months
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Time frame: 3 months, 6 months, 12 months
Increase of grip strength
Grip strength measured in kg by grip strength test using a dynamometer
Time frame: 3 months, 6 months, 12 months
No apparent joint space anomaly
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Hôpitaux Universitaires de Strasbourg
Strasbourg, France
RECRUITINGJoint space evaluated on radiography using Crosby's classification
Time frame: 12 months