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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757354

Enrollment

Registered

2008-09-23

Start date

2012-06-30

Completion date

2014-03-31

Last updated

2017-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

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.

Interventions

PROCEDUREMetal on Metal cementless hip

Metal on Metal hip arthroplasty

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
concentration of Cobalt, Chromium and Molybdenum ions in urine	various follow-up visits

Secondary

Measure	Time frame
harris Hip Score, oxford hip, WOMAC and SF-12	various follow-up visits

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026