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Completed

NCT Number: NCT00754520

A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Finland Central Hospital, Jyväskylä, Finland

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About this study

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
  • Patients preoperative Harris Hip Score <= 70 points
  • Patients aged over 18 and under 75
  • Patients with limited co-morbidity - ASA I-III
  • Patients with normal urea and electrolyte levels and creatinine levels
  • Patients must be able to understand instructions and be willing to return for follow-up
  • Patients willing to provide blood and urine samples for metal ion analysis at follow up

Exclusion criteria

  • Patients preoperative Harris Hip Score > 70 points
  • Previous prosthetic hip surgery
  • Patients with significant co-morbidity - ASA IV - V
  • Dementia and inability to understand and follow instructions
  • Neurological conditions affecting movement
  • Existing metal implant or fixation device
  • Pregnancy
  • Presence of symptomatic arthritis in other lower limb joints

Treatment and study plan

Ceramic On Metal

Device

Ceramic on Metal articulation using M2a-38™ mm cup

Metal on Metal

Device

Metal on Metal articulation using M2a-38™ mm cup

Primary outcomes

  1. Composite Clinical Success (CCS) Rate as Defined in the Protocol

    Time frame: 2 years post-operatively

    CCS is defined as:

    a. Total Harris Hip Score > 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:

    • Migration < 4 mm, and
    • Change in angle of inclination < 4o, and
    • Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following:
    • Subsidence < 5 mm, and 2. Absence of osteolysis.

    The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70

Secondary outcomes

  1. Oxford Hip Score

    Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively

    The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.

  2. Womac Score

    Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.

  3. Metal Ion Concentrations in Blood

    Time frame: 6 months post-operatively, 1, 2, 3 and 5 years post-operatively

    Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.

  4. Survivorship

    Time frame: 10 years post-op

    Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2008
Registry last updated
Oct 2, 2024

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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