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Completed

NCT Number: NCT00757354

A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty

A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Traumatic Arthritis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avon Orthopaedic Centre

Bristol, United Kingdom

About this study

This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless total hip arthroplasty.

The amount of metallic ions released post operatively will be assessed by the concentration of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to the hip function and range of motion measured pre-operatively and post-operatively. Secondary performance of the metal-on-metal articulation will be determined by radiographic evaluation and incidence of complications / revision rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:
  • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
  • Rheumatoid arthritis.
  • Selection of subjects for this Evaluation should include the following considerations:
  • Patients under 70 years of age.
  • Willing to return for follow-up evaluations.
  • No bias to sex.

Exclusion criteria

Treatment and study plan

Metal on Metal cementless hip

Procedure

Metal on Metal hip arthroplasty

Other names: metal on metal hip arthroplasty

Primary outcomes

  1. concentration of Cobalt, Chromium and Molybdenum ions in urine

    Time frame: various follow-up visits

Secondary outcomes

  1. harris Hip Score, oxford hip, WOMAC and SF-12

    Time frame: various follow-up visits

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • Biomet U.K. Ltd.

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 23, 2008
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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