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

Primary Purpose

Osteoarthritis, Avascular Necrosis, Traumatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metal on Metal cementless hip
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Avon Orthopaedic Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metal on Metal cementless hip

Arm Description

Metal on Metal cementless hip arthroplasty

Outcomes

Primary Outcome Measures

concentration of Cobalt, Chromium and Molybdenum ions in urine

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2008
Last Updated
June 16, 2017
Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00757354
Brief Title
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Official Title
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
Biomet U.K. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metal on Metal cementless hip
Arm Type
Experimental
Arm Description
Metal on Metal cementless hip arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Metal on Metal cementless hip
Other Intervention Name(s)
metal on metal hip arthroplasty
Intervention Description
Metal on Metal hip arthroplasty
Primary Outcome Measure Information:
Title
concentration of Cobalt, Chromium and Molybdenum ions in urine
Time Frame
various follow-up visits
Secondary Outcome Measure Information:
Title
harris Hip Score, oxford hip, WOMAC and SF-12
Time Frame
various follow-up visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evert J Smith, FRCS
Organizational Affiliation
Avon Orthopaedic Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avon Orthopaedic Centre
City
Bristol
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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