Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01721278 |
| Other study ID # |
12/LO/0768 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2012 |
| Est. completion date |
October 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Imperial College London |
| Contact |
Justin Cobb, MCh FRCS |
| Phone |
02033117687 |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring
function. Many different implants can be used in artificial hip joints. Hydroxyapatiteceramic
(HAC) coating has become a well established The JRI Furlong® HAC femoral stem is one such
implant with good long term survivorship. The femoral implant has been used since 1985 and
published findings have shown a 97.4% survivorship at a mean of 17 years follow up in
patients. The Furlong Evolution® design is based on the tried and tested Furlong HAC but with
some modifications.
This is a 10 year multicentre clinical surveillance study, which aims to assess the clinical,
functional and radiological performance of the Furlong Evolution® Hip stem in human patients.
Description:
Purpose and Design:
The Furlong Evolution® design is based on the tried and tested Furlong H.A.C implant but with
some modifications. It still retains its full H.A.C coating and is much shorter in length.
This potentially makes it easier to introduce into the femoral canal, which may result in
less soft tissue damage and lower rate of femoral fracture. This would be very beneficial,
should revision (implant replacement) be required at a later date. This potential
characteristic has been highlighted as an important component of determining the clinical
effectiveness of a total hip replacement.
As per the National Institute of Clinical Excellence (NICE) guidelines the best prostheses
demonstrates a revision rate (the rate at which they need to be replaced) of 10% or less at
10 years. This should be regarded as the current benchmark in the selection of prostheses for
primary Total Hip Replacement (THR). It is also considered reasonable to recommend a
prostheses with a maximum of 3% revision rate at 3 years which would indicate performance
would then be subjected to annual review (up to 10 years) to ensure that the revision rate
remains consistent with the 10year benchmark. The Orthopaedic Data Evaluation Panel (ODEP)
was established to evaluate data on the outcomes of prostheses provided by manufactures and
to inform the NHS which products are compliant with the benchmarks set by NICE. Therefore
this study will be a ODEP compliant multicentre prospective surveillance study of the Furlong
Evolution® Hip Stem that will assess the clinical, functional and radiographical performance
over a 10 year period in compliance with the NICE guidelines.
