EAGLE
Research type
Research Study
Full title
Evaluation of an Acellular Osteochondral Graft for Cartilage LEsions European Post Market Study
IRAS ID
168516
Contact name
Forde Hansell
Contact email
Sponsor organisation
DSM Biomedical
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NL50131.068.14, toetsingonline
Duration of Study in the UK
7 years, 5 months, 28 days
Research summary
BioMatrix CRD surgery study: cartilage is a tissue that covers the bones in the knee joint. Injury and excessive wear can cause rough spots or holes in the cartilage, which can be painful. However, cartilage in the knee joint has a limited ability to heal on its own. Therefore, during knee surgery, implants like the BioMatrix CRD can be used with the intention to aid repair of the damaged cartilage.
The safety and performance of the BioMatrix CRD was demonstrated in earlier studies and the device received the CE Mark in 2010. This study is being conducted to confirm the results seen in the earlier studies. The BioMatrix CRD is shaped like a cylinder and has two layers. The top layer consists of collagen fibres like those found in normal cartilage. The collagen layer is about as thick as the cartilage in human knees. The bottom layer of the BioMatrix CRD mainly consists of a mineral found naturally in human bones (called tricalcium phosphate). The mineral
is held within a degradable polymer material. The device has a weave-like structure to help the body’s own repair process. During the healing process, the top layer is designed to be replaced by cartilage and the bottom layer is designed to be replaced by bone.The potential benefit of the BioMatrix CRD is that it may produce better and stronger cartilage than other knee cartilage repair procedures. The BioMatrix CRD may contribute to reduced knee pain and increased knee function. However, it is possible that participants will receive no benefits from the use of the BioMatrix CRD. Also the information gained from this study may be of benefit to other people with the same condition in future.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0062
Date of REC Opinion
26 Mar 2015
REC opinion
Further Information Favourable Opinion