NCT03905174

Massive Implants the Next Generation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Iva Hauptmannova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bone Cancer
• Bone Diseases

Interventions

Type	Name	Description
DEVICE	custom made device	surgical intervention to place custom made orthopaedic device

Timeline

• Start date: 2018-09-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-04-05
• Last updated: 2022-06-07

Locations

1 site across 1 country: United Kingdom