A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA or Porous Collar With HA and Autologous Stem Cells
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Radiological outcomes (X-ray, CT)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bone cancer patients requiring primary or revision femoral segmental replacements and non-cancer patients requiring revision femoral segment replacement for aseptic loosening
- •Male or female, aged 18 years or above
- •Able to provide consent
Exclusion Criteria
- •unable/unwilling to consent
- •revisions surgery due to infection
- •bone cancer patients excluded from stem cell arm
- •bone cancer patients with pathological fractures
Arms & Interventions
Standard treatment
A porous collar for either distal or proximal femoral replacements
Intervention: custom made device (Device)
standard treatment + HA
A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements
Intervention: custom made device (Device)
standard treatment + HA + autogenic cells
A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements
Intervention: custom made device (Device)
Outcomes
Primary Outcomes
Radiological outcomes (X-ray, CT)
Time Frame: at 2 years (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
Radiological outcomes (X-ray, CT)
Time Frame: at 26 weeks (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
Radiological outcomes (X-ray, CT)
Time Frame: at 1 year (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
Secondary Outcomes
- Visual Analogue Score (VAS) pain score(up to 2 years (+/- 2 weeks))
Investigators
Iva Hauptmannova
Head of Research & Innovation
Royal National Orthopaedic Hospital NHS Trust