Assessment of bone graft substitute in high tibial osteotomy
Research type
Research Study
Full title
Post Market Clinical Follow up - Assessment of HydroxyColl bone graft substitute in high tibial osteotomy wedge grafting.
IRAS ID
225548
Contact name
Mike Risebury
Contact email
Sponsor organisation
SurgaColl Technologies Limited
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Autologous bone graft (i.e. bone harvested from the patient's own body during surgery from a donor location, usually from the hip) would be still the best choice for a lot of applications where bone grafting is needed to help repair fractures or fill gaps in the body. However there are many disadvantages – high risk of donor site damage and the limited amount of high quality bone which can be harvested. New biomaterials, such as Hydroxycoll, which are made of naturally derived materials that are already within the body, offer exciting prospects of improved patient clinical outcomes and may provide a viable alternative autologous bone grafts. Specifically, they offer the ability to speed up healing and are completely dissolved by the body as they are replaced by the patient's own healed bone, meaning that they also don't persist in the body, an obvious advantage over traditional long term implants. This study will assess the performance of HydroxyColl when treating patients who require high tibial osteotomy to treat osteoarthritis of the knee and associated lower leg alignment issues. High tibial osteotomy requires the removal of a large amount of bone tissue to facilitate re-alignment of the lower leg, in combination but implanted plates and screws for leg stability and load bearing. While not using a bone graft to fill this surgically created gap has been shown to be adequate and safe, it nevertheless creates a gap lower leg bone that can result in excessive bleeding and pain for the patient. To enhance bone healing and increase initial mechanical stability, a large osteotomy may benefit from the use of bone graft/substitute to fill the osteotomy gap. This study will assess the performance of HydroxyColl compared to standard of care.
REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/1416
Date of REC Opinion
8 Nov 2017
REC opinion
Further Information Favourable Opinion