The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus 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 meniscus used as interposition at the STT joint
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, France
Decrease 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 toxicity
Absence of adverse events
Time frame: Through study completion - average of 12 months
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test
Time frame: 1 month, 3 months, 6 months, 12 months
Decrease of pain related to STT OA
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months
No apparent anomaly of joint space
Joint space evaluated on radiography using Crosby's classification
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.