The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA, and autologous stem cell augment. This is a randomised controlled trial.
The current surgical treatment of bone cancer patients and revision limb salvage requires usage of massive endoprosthetic bone implants. The incidence of aseptic loosening is a major cause of prosthesis failure in these patients, exploring ways to reduce such failures would allow extending longevity of massive implants in a relatively young population. Current published literature stipulates that osteointegration could improve longevity of massive implants. Evidence suggests that usage of osteointegrated hydroxyapatite (HA) coated collar would reduce the incidence of aseptic loosening around the cemented intramedullary stem in distal femoral bone prosthesis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
surgical intervention to place custom made orthopaedic device
Royal National Orthopaedic Hospital NHS Trust
London, Middx, United Kingdom
RECRUITINGRadiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Time frame: at 26 weeks (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Time frame: at 1 year (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Time frame: at 2 years (+/- 2 weeks)
Visual Analogue Score (VAS) pain score
visual analogue pain score to determine improvement of pain over time, 0 to 10 scale will be used (0 = no pain, higher the number the worse the pain)
Time frame: up to 2 years (+/- 2 weeks)
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