Woven OGmend Implant
Research type
Research Study
Full title
Woven Orthopedic Technologies OGmendTM Implant System
IRAS ID
228000
Contact name
Bob Luzzi
Contact email
Sponsor organisation
Woven Orthopedic Technologies, LLC
Duration of Study in the UK
1 years, 1 months, days
Research summary
A prospective, multicenter, non-controlled, clinical trial to evaluate the safety and performance of the Woven Orthopedics OGmend System in subjects who require interbody fusion with posterior rigid fixation or dynamic stabilization of the spine in skeletally mature subjects.\n\nWoven Orthopedic Technologies’ OGmend Implant is a permanently implanted, polymer braided sleeve that provides enhanced fixation of bone screws when screw engagement is compromised. The OGmend Sleeve has been designed to offer surgeons a simpler and safer surgical alternative when performing screw/hardware rescue techniques. When a screw loosens, stability of the fixation system is compromised that may lead to pain and discomfort to the patient and ultimately to failure of the procedure.\nThe primary goal of the study is to demonstrate the short-term clinical performance and safety of the Woven Orthopedics OGmend System when used in conjunction with spinal fixation systems (pedicle screws and rods) in posterior lumbar interbody fusion procedures or dynamic stabilization.\n
REC name
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0130
Date of REC Opinion
28 Jul 2017
REC opinion
Further Information Favourable Opinion