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| Name | Class |
|---|---|
| Adler Ortho | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator | A porous collar for either distal or proximal femoral replacements |
|
| standard treatment + HA | Active Comparator | A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements |
|
| standard treatment + HA + autogenic cells | Active Comparator | A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| custom made device | Device | surgical intervention to place custom made orthopaedic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological outcomes (X-ray, CT) | radiological outcomes to determine integration of implant into bone - bone growth | at 26 weeks (+/- 2 weeks) |
| Radiological outcomes (X-ray, CT) | radiological outcomes to determine integration of implant into bone - bone growth | at 1 year (+/- 2 weeks) |
| Radiological outcomes (X-ray, CT) | radiological outcomes to determine integration of implant into bone - bone growth | at 2 years (+/- 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 2 years (+/- 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panos Gikas, PhD FRCS | Contact | 02089092300 | rnoh.research@nhs.net | |
| Esther Hanison, BSc | Contact | 02089092300 | rnoh.research@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Panos Gikas, PhD FRCS | Royal National Orthopaedic Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal National Orthopaedic Hospital NHS Trust | Recruiting | London | Middx | HA7 4LP | United Kingdom |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009140 | Musculoskeletal Diseases |
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