Latella-2
Research type
Research Study
Full title
Evaluation of the LatellaTM Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
IRAS ID
165414
Contact name
Manoj Ramachandran
Contact email
Sponsor organisation
Cotera, Inc.
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This is a prospective, non-randomized open label, single-arm, multi-center study to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain. The device is designed to shift the the illiotibial (IT) band, so that when the lateral muscles attached to the IT band contract, they generate a larger moment (rotational force) about the knee joint to reduce the contact force within the medial condyle of the knee and therefore reduce pain.
The study will involve up to (fifteen) 15 centres in Europe including up to four in the UK. Globally up to fifty-five (55) subjects will be implanted with Latella device. A maximum of 20 subjects will be implanted with the device in the UK. Patients will be enrolled who suffer from medical osteoarthritis of the knee between the ages of 30 and 70 with Kellgren-Lawrence scores (the system most used to assess the severity of osteoarthritis) of 2-3 and who have had a history of pain of 6 months with failure of pain relief with conservative treatments.
Total duration of the study is 30 months: enrolment 6 months and a follow-up phase of 24 months.
The primary objective of the study is efficacy and safety. The efficacy will be evaluated by the the mean change in KOOS pain score at 6 Months after treatment with the Latella Implant. The primary safety will be evaluated by the surgical re-intervention during the 6 Month period following implantation of the Latella device.
Change in KOOS function score, medial knee pain NRS (while walking), IKDC, KOOS responder rate at 6, 12 and 24 Months post-surgery, together with KOOS pain score at 12 and 24 months post treatment and device related complication through 24 months post treatment will be evaluated as secondary objectives.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/1279
Date of REC Opinion
30 Apr 2015
REC opinion
Further Information Favourable Opinion