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Completed

NCT Number: NCT01522014

Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. With the reported high success rate of this surgical intervention, the THA surgery is being performed in younger patients who have significant joint disease.

A clinical trial, using a randomized blinded design, was undertaken to compare the functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis of the hip.

Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year follow-up is currently underway.

The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the RAND-12, as well as measurement of complication and revision rates. The patient's demand on the implant as calculated by the patient's age, weight, health status and activity level was also measured.

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Key information

Conditions

Total Hip Replacement

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Alexandra Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females scheduled for primary THA to treat non-inflammatory arthritis
  • Less than 61 years old at time of surgery
  • Able to speak and read the English language or have an available translator
  • Dorr Index A or B bone quality on preoperative radiographs
  • Willing and able to return for follow-up visits

Exclusion criteria

  • Have femoral or acetabular bone deficiency requiring augmentation
  • Ongoing corticosteroid use
  • Dorr Index C bone quality on the preoperative radiograph
  • Required a prosthesis neck length of greater than five millimeters

Treatment and study plan

Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head

Device

Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head

Device

Primary outcomes

  1. Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score

    Time frame: Five Years

    This is a disease-specific, patient reported outcome measure of pain.

  2. WOMAC Function Score

    Time frame: Five years

    This is a disease-specific patient reported outcome measure of function

  3. WOMAC Stiffness Score

    Time frame: Five Years

    This is a disease-specific, patient-reported outcome measure of stiffness.

Secondary outcomes

  1. WOMAC Pain Score

    Time frame: One Year

    This is a disease-specific, patient-reported outcome measure of pain.

  2. WOMAC Function Score

    Time frame: One Year

    This is a disease-specific, patient-reported outcome measure of function.

  3. WOMAC Stiffness Score

    Time frame: One Year

    This is a disease-specific, patient-reported outcome measure of stiffness.

  4. RAND 12-Item Health Survey (RAND-12)

    Time frame: Five Years

    This is a generic patient-reported outcome measure of health status.

  5. RAND-12

    Time frame: One years

    This is a generic patient-reported outcome measure of health status.

  6. Complications

    Time frame: Five Years

    This measured the postoperative complications.

  7. Revisions

    Time frame: Five Years

    This measured the number of revisions in five years

  8. WOMAC Pain Score

    Time frame: 10 Years

  9. WOMAC Function Scores

    Time frame: 10 years

  10. WOMAC Stiffness Score

    Time frame: 10 years

  11. RAND-12

    Time frame: 10 years

  12. Complications

    Time frame: 10 years

  13. Revision Rate

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Stryker Canada LP

Registry information

Official study title

Five-Year Outcome of Ceramic on Ceramic Bearing Versus Ceramic on Crossfire® Highly Cross-Linked Polyethylene Bearing in Primary Total Hip Arthroplasty: A Randomized Trial

Important dates

Study start
1997
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2012
Registry last updated
Jul 28, 2021

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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