Cultured Chondrocytes Vs. Cultured BMAC
Research type
Research Study
Full title
A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. the use of Cultured bone marrow aspirate cells.
IRAS ID
121663
Contact name
Asode Ananthram Shetty
Contact email
Sponsor organisation
Department of Minimally Invasive Surgery, Canterbury Christ Church University
Research summary
Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will not be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty’s clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores; cartilage growth will be measured by the MOCART score.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, cartilage growth and improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
13/LO/1781
Date of REC Opinion
31 Mar 2014
REC opinion
Further Information Favourable Opinion