Furlong Evolution® Hip Trial
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|ClinicalTrials.gov Identifier: NCT01721278|
Recruitment Status : Recruiting
First Posted : November 5, 2012
Last Update Posted : January 13, 2016
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.
|Condition or disease|
|Focus: A Multicentre Prospective Clinical Surveillance Study Aims to Assess the Clinical, Functional and Radiological Outcome of the Furlong Evolution® Hip Stem|
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.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||A Prospective Multicentre Clinical Surveillance Study To Evaluate The Stability, Efficacy And Safety Of The Furlong Evolution® Hip Stem In Primary Total Hip Arthroplasty|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
- The performance of the Furlong Evolution Hip Stem will be assessed clinically and radiographically of all participants. Number of participants who have reported complications, adverse events & serious adverse events will act as a measure of safety. [ Time Frame: 10 years ]
- Questionnaires (Oxford Hip,EQ5D & Harris Hip Score) will be obtained from participating subjects to evaluate patient function & satisfaction & quality of life at each follow up visit. [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721278
|Contact: Justin Cobb, MCh FRCS||02033117687|
|Contact: Hardeep Johal, BSc (Hons)||020 firstname.lastname@example.org|
|Charing Cross hospital||Recruiting|
|London, United Kingdom, w6 8rf|
|Contact: Hardeep Johal, BSc (Hons) 020 33115216 email@example.com|
|Principal Investigator:||Professor Justin Cobb, MCh FRCS||Imperial College London|