Massive Implants the Next Generation

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Bone Cancer, Bone Diseases

Intervention / Treatment
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* Device: custom made device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bone cancer patients requiring primary or revision femoral segmental replacements and non-cancer patients requiring revision femoral segment replacement for aseptic loosening Male or female, aged 18 years or above Able to provide consent Exclusion Criteria: unable/unwilling to consent revisions surgery due to infection bone cancer patients excluded from stem cell arm bone cancer patients with pathological fractures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>A porous collar for either distal or proximal femoral replacements | Device: custom made device<br>* surgical intervention to place custom made orthopaedic device<br>* Other names: custom orthopaedic implantable device;|
| Active Comparator: standard treatment + HA<br>A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements | Device: custom made device<br>* surgical intervention to place custom made orthopaedic device<br>* Other names: custom orthopaedic implantable device;|
| Active Comparator: standard treatment + HA + autogenic cells<br>A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements | Device: custom made device<br>* surgical intervention to place custom made orthopaedic device<br>* Other names: custom orthopaedic implantable device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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revision surgery