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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Radiological outcomes (X-ray, CT)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •unable/unwilling to consent
- •revisions surgery due to infection
- •bone cancer patients excluded from stem cell arm
- •bone cancer patients with pathological fractures
结局指标
主要结局
Radiological outcomes (X-ray, CT)
时间窗: at 2 years (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
次要结局
- Visual Analogue Score (VAS) pain score(up to 2 years (+/- 2 weeks))
研究者
Iva Hauptmannova
Head of Research & Innovation
Royal National Orthopaedic Hospital NHS Trust