Multigen Plus CCK and AMF TT Cones V 2.0
Research type
Research Study
Full title
A prospective, post-marketing study evaluating clinical and radiographic early outcomes of Total Knee Arthroplasty with Multigen Plus CCK alone or involving the AMF TT cones.
IRAS ID
313838
Contact name
Jonathan Phillips
Contact email
Sponsor organisation
LimaCorporate S.p.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
The research study is to determine how well the Multigen Plus CCK knee prosthesis works when implanted in patients with unstable knee joints or those with poor ligament function either alone or with AMF TT cones when used in initial or revision knee replacement surgeries. The Multigen Plus CCK knee prosthesis is CE marked and approved for use in UK and Europe. For patients that choose to participate, data will be collected on the prosthesis and the knee function from before the knee surgery and up to 2 years after the surgery.
The study will enrol 68 subjects across up to 3 sites; 2 in Europe and 1 in UK. It is anticipated that recruitment will be completed within 2 years. Participants will attend a pre-operative visit before the device implant, intra-operative visit, (same day as device implant), Day 1 after the implant, and follow-up visits at 3 months and 1 year, 2 years after the implant.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0140
Date of REC Opinion
29 Jul 2022
REC opinion
Further Information Favourable Opinion