Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-09-20
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard treatment
A porous collar for either distal or proximal femoral replacements
custom made device
surgical intervention to place custom made orthopaedic device
standard treatment + HA
A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements
custom made device
surgical intervention to place custom made orthopaedic device
standard treatment + HA + autogenic cells
A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements
custom made device
surgical intervention to place custom made orthopaedic device
Interventions
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custom made device
surgical intervention to place custom made orthopaedic device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female, aged 18 years or above
* Able to provide consent
Exclusion Criteria
* revisions surgery due to infection
* bone cancer patients excluded from stem cell arm
* bone cancer patients with pathological fractures
18 Years
ALL
No
Sponsors
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Adler Ortho
UNKNOWN
Iva Hauptmannova
OTHER
Responsible Party
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Iva Hauptmannova
Head of Research & Innovation
Principal Investigators
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Panos Gikas, PhD FRCS
Role: PRINCIPAL_INVESTIGATOR
Royal National Orthopaedic Hospital NHS Trust
Locations
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Royal National Orthopaedic Hospital NHS Trust
London, Middx, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017/MING
Identifier Type: -
Identifier Source: org_study_id
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