An interventional study of custom made device in Bone Cancer and Bone Diseases, sponsored by Iva Hauptmannova. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-07.
Sponsored by Iva Hauptmannova · Not applicable, Interventional, and Prevention
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.
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
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 163 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Iva Hauptmannova is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A porous collar for either distal or proximal femoral replacements
Device: custom made device
A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements
Device: custom made device
A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements
Device: custom made device
surgical intervention to place custom made orthopaedic device
Also known as: custom orthopaedic implantable device
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Time frame: at 26 weeks (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Time frame: at 1 year (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Time frame: at 2 years (+/- 2 weeks)
Visual Analogue Score (VAS) pain score
visual analogue pain score to determine improvement of pain over time, 0 to 10 scale will be used (0 = no pain, higher the number the worse the pain)
Time frame: up to 2 years (+/- 2 weeks)
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Iva Hauptmannova