Status:
UNKNOWN
Megaprosthetic Implants the Next Generation (MING)
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Adler Ortho, iEthos Medical Ltd
Conditions:
Bone Neoplasm of Hip (Diagnosis)
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03780036
Start Date
February 1 2019
End Date
August 1 2022
Last Update
December 19 2018
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