Evaluation of the Latella Device
Research type
Research Study
Full title
Evaluation of the Latella Device for Lateralization of the Illiotibial Band to Offload the Lateral Condyle for Pain Relief in Patients with Medial Osteoarthritis – A Safety Study
IRAS ID
129836
Contact name
Manoj Ramachandran
Contact email
Sponsor organisation
Cotera, Inc.
Research summary
This is a prospective, non-randomized, single-arm, multi-centre study to evaluate the safety and technical feasibility of implanting the Latella device to treat patients with medial osteoarthritis of the knee. The device is designed to shift the the illiotibial (IT) band, which helps stabilise the knee laterally, so that when the lateral muscles overlying 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 and slow down degeneration of the knee.
The study will involve up to three centres in Europe including one in the UK. Globally twelve (12) subjects will be implanted with Latella device, therefore a maximum of 6 subjects will be implanted with the device in the UK. Patients will be enrolled who suffer from medial osteoarthritis of the knee between the ages of 30 and 55 with Kellgren-Lawrence scores (the system most used to assess the severity of osteoarthritis) of 2-3 and who have had arthroscopically confirmed medial osteoarthritis within the previous 3 years. Total duration of the study is 21 months: enrolment 9 months and a follow-up phase of 12 months.
The primary objective of the study is safety which will be evaluated by freedom from unanticipated serious device related adverse events and freedom from radiographic evidence of screw loosening to 12 months post treatment.
Technical feasibility as the secondary endpoint of the investigation will be evaluated by the ability of Latella to be placed under the IT band and fixed to the distal, lateral aspect of the femur. In addition, patient questionnaires will be used to score joint specific, disease specific and general Quality of Life measures, while radiographic and MRI analysis will be used to evaluate anatomical changes and status.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0201
Date of REC Opinion
6 Sep 2013
REC opinion
Further Information Favourable Opinion