Bone Neoplasm of Hip (Diagnosis) Clinical Trial
Official title:
A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA
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 recruitment will continue for 18 months. Parameters to be investigated are radiographic measures of bone incorporation into the implants, as well as patient functional outcomes. Clinical follow-up will last for 24 months for each patient.
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 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.
Our study aims to compare radiological outcome in 2 groups:
- A porous collar for either distal or proximal femoral replacements
- A porous collar with hydroxyapatite (HA) for either distal or proximal femoral
replacements The porous collar will be manufactured by Adler Ortho using additive layer
manufacturing technology.
STUDY OBJECTIVES The study will review the use of massive segmental replacements in the
femur, which have a porous collar with and without HA.
Primary objectives:
The primary objective of the study will be to assess radiological outcome by assessing bony
growth into the collar.
Secondary objectives The secondary objective will focus on assessing patient reported outcome
measures (VAS pain score and other PROMS)
STUDY DESIGN
Patients will be identified in the outpatient setting as suitable for entry into the trial
based on the inclusion and exclusion criteria as set out below.
Patients will be randomised into one of the two groups of the study, due to the nature of
intervention this will be a single blind study.
Patients will undergo plain radiographs immediately post-operatively, at 6 months
post-operatively, 12 months post-operatively and 24 months post-operatively. Standard
protocol radiographs of the relevant limb will be taken in the antero-posterior (AP) and
medial-lateral (ML) planes (x2 AP and x2 laterals to cover the prosthesis).
At 12 months and 24 months post-operatively patients will receive a CT scan (cover whole
prosthesis, extended CT - knee, pelvis), which will be used to image bone growth within the
porous collars.
For plain radiographs a scoring system for extra-cortical bone formation will be made
according to Coathup et al, 2013. This will be quantified radiologically in four zones
(medial and lateral aspects on AP radiographs; anterior and posterior aspects on ML
radiographs). Extracortical bone separated from the implant by a clear radiolucent line is
not considered in grown and will be scored 0. A score of 1 will represent extracortical bone
(>5mm think and >1mm long) in contact with the implant surface in any of the four previously
described zones. The maximum score will be 4, denoting extracortical bone growth in all four
zones.
Patients identified and consented in clinic for entry into study. Randomisation prior to
surgical date. Baseline X-ray and CT done pre-operatively as per current pre-operative
guidelines.
Pre-operative bloods and joint aspiration done to definitively rule out infection in revision
patients Pre-operative VAS pain score on admission
Joint replacement done - clarify antibiotic prophylaxis with surgeons - induction + extended
post-operative antibiotic prophylaxis
Post-operative Toronto Extremity Salvage Score (TESS) to assess physical functioning for all
patients. TESS repeated at 6, 12 and 24 months to assess progress post-operatively -
correlating with radiographical findings.
Surgery related data including theatre time, intra-operative blood loss and intra- and
post-operative complications will be recorded for all patients.
Immediate post-operative, 6, 12 and 24 monthly X-rays (x2 AP and x2 laterals to cover the
prosthesis); 12 and 24 monthly CT (cover whole prosthesis, extended CT - knee, pelvis) X-rays
and CT reported by scores calculated as previously described.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03453905 -
Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.
|
N/A |