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Status:

COMPLETED

Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study

Lead Sponsor:

Smith & Nephew Orthopaedics AG

Conditions:

Primary Osteoarthritis

Secondary Osteoarthritis

Eligibility:

All Genders

Brief Summary

This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.

Detailed Description

The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnai...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Those presenting with primary or secondary osteoarthritis or avascular necrosis of the femoral head or patients suitable for a primary total hip replacement. This is the patient group that will benefit from operative surgery to treat osteoarthritis.
  • Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. Patients capable of giving informed consent are eligible for inclusion into the study.
  • Participants who signed the Ethics Committee approved specific Informed Consent Form prior to surgery. Patients who have not given informed consent will not be eligible for inclusion into the study.
  • Exclusion criteria:
  • Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
  • Patients not suitable for primary hip replacement.
  • Patients with active or suspected infection.

Exclusion

    Key Trial Info

    Start Date :

    April 30 2007

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 8 2021

    Estimated Enrollment :

    270 Patients enrolled

    Trial Details

    Trial ID

    NCT04425603

    Start Date

    April 30 2007

    End Date

    November 8 2021

    Last Update

    September 30 2022

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    William Harvey Hospital East Kent NHS Trust

    Ashford, United Kingdom, TN24 0LZ

    2

    Ashford and St. Peter's NHS Trust

    Chertsey, United Kingdom, KT16 OPZ

    3

    South West London Elective Orthopaedic Centre (SWLEOC)

    Epsom, United Kingdom, KT18 7EG

    4

    Royal Berkshire NHS Foundation Trust

    Reading, United Kingdom, RG1 5AN