Furlong Evolution® Hip Trial

A Prospective Multicentre Clinical Surveillance Study To Evaluate The Stability, Efficacy And Safety Of The Furlong Evolution® Hip Stem In Primary Total Hip Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Focus: A Multicentre Prospective Clinical Surveillance Study Aims to Assess the Clinical, Functional and Radiological Outcome of the Furlong Evolution® Hip Stem

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Justin Cobb, MCh FRCS; Phone Number: 02033117687
• Study Contact Backup: Name: Hardeep Johal, BSc (Hons); Phone Number: 020 33115216; Email: h.johal@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Recruiting
    • Charing Cross Hospital
    • Contact: Hardeep Johal, BSc (Hons); Phone Number: 020 33115216; Email: h.johal@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

As per ODEP guidelines, a minimum of 500 cohort size is required for benchmark validation of the clinical performance of a new orthopaedic implant. We will be using a total sample size of 700 patients over 10 centres to ensure we meet the benchmark validation criteria.

Description

Inclusion Criteria:

1. All patients consenting to total hip replacement
2. All patients deemed suitable for total hip replacement
3. All patients passing pre-assessment deeming them medically fit enough for total hip replacement.

Exclusion Criteria:

1. Patients deemed unsuitable for Total Hip Replacement
2. Patients who refuse to have surgery opting for other modes of treatment
3. Patients who are unable to consent due to a lack of capacity
4. Patients unable to understand English
5. Any patient under the age of 18 years.
6. Patients who are pregnant or breast feeding

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Joint Replacement Instrumented Orthopaedics Ltd
• Investigators: Principal Investigator: Professor Justin Cobb, MCh FRCS, Imperial College London

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: November 1, 2012
• First Posted (ESTIMATE): November 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 12/LO/0768