A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Bone incorporation
研究概览
简要总结
This is an interventional randomized controlled trial that will compare patients who underwent segmental hip replacement using mega-implants with either porous collar or porous collar with HA. Patient recruitment will continue for 18 months. Parameters to be investigated are radiographic measures of bone incorporation into the implants, as well as patient functional outcomes. Clinical follow-up will last for 24 months for each patient.
详细描述
BACKGROUND The current surgical treatment of bone cancer patients 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.
Our study aims to compare radiological outcome in 2 groups:
- A porous collar for either distal or proximal femoral replacements
- A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements The porous collar will be manufactured by Adler Ortho using additive layer manufacturing technology.
STUDY OBJECTIVES The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant will not know which implant was used for segmental replacement of his or hear femur.
入排标准
- 年龄范围
- 18 Years 至 80 Years（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 (excluding infections) and non-cancer patients requiring revision femoral segment replacement for aseptic loosening (excluding infections)
- •Male or female, aged 18-80 years
- •Participants willing and able to give informed consent for participation in the study
排除标准
- •Participants unwilling or unable to give informed consent for participation in the study
- •Patients undergoing revision due to infection, identified by positive growth from joint aspiration OR elevated pre-operative inflammatory markers OR radiographical evidence of prosthetic joint infection
- •Bone cancer patients presenting with pathological fractures requiring segmental femoral replacement
研究组 & 干预措施
porous collar
Patients with neoplasm of femur bone who require segmental bone resection and replasement with a large prosthesis would receive an implant which collar (a circular part that comes into direct contact with the remaining bone) will be porous, to allow for bone ingrowth and stabilization of the implant.
干预措施: Megaprosthetic Implants the Next Generation (MING) (Device)
porous collar with hydroxyapathite
Patients with neoplasm of femur bone who require segmental bone resection and replasement with a large prosthesis would receive an implant which collar (a circular part that comes into direct contact with the remaining bone) will be porous and covered with hydroxyapathite particles, to allow for bone ingrowth and stabilization of the implant.
干预措施: Megaprosthetic Implants the Next Generation (MING) (Device)
结局指标
主要结局
Bone incorporation
时间窗: 24 months
Radiographic evidence of bony growth into the collar
次要结局
- Functional outcome - Visual Analogue Pain Scale(24 months)
- Functional outcome - a physical functioning score(24 months)