A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Primary Endpoint
- Bone incorporation
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The participant will not know which implant was used for segmental replacement of his or hear femur.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Megaprosthetic Implants the Next Generation (MING) (Device)
Outcomes
Primary Outcomes
Bone incorporation
Time Frame: 24 months
Radiographic evidence of bony growth into the collar
Secondary Outcomes
- Functional outcome - Visual Analogue Pain Scale(24 months)
- Functional outcome - a physical functioning score(24 months)