TIB N-FORCE
Research type
Research Study
Full title
Tibia plateau pure and split depression fractures (AO 41-B2 and B3) stabilised with N-Force/iN3 bone cement +/- plate augmentation: A prospective single centre feasibility RCT comparing early (2 weeks) versus delayed (6 weeks) weight bearing.
IRAS ID
237923
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
After surgical fixation for a tibial plateau fracture patients are often advised not to weight bear for six weeks. This delayed weight bearing allows the fracture time to heal, however it has been associated with other complications, such as osteoporosis. Advances in fixation techniques, such as the N-Force cement to be used in this study, allow for weight bearing sooner after the surgery, which could avoid the complications associated with delayed weight bearing. This study will examine the feasibility of conducting a full randomised controlled trial of early versus delayed weight bearing. 50 patients who have tibial fracture fixation with N-force cement will be randomised to either early weight bearing (2 weeks) or late weight bearing (six weeks after surgery). They will then be followed up for a year afterwards to compare their healing and the impact on quality of life and health economic outcomes.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0293
Date of REC Opinion
18 Sep 2018
REC opinion
Further Information Favourable Opinion