NCT01522014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

11.2 years

First QC Date

January 26, 2012

Last Update Submit

July 23, 2021

Conditions

Total Hip Replacement

Keywords

Joint ReplacementHealth Related Quality of LifeFunctional OutcomesRevision Rate

Outcome Measures

Primary Outcomes (3)

  • Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score

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

    Five Years

  • WOMAC Function Score

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

    Five years

  • WOMAC Stiffness Score

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

    Five Years

Secondary Outcomes (13)

  • WOMAC Pain Score

    One Year

  • WOMAC Function Score

    One Year

  • WOMAC Stiffness Score

    One Year

  • RAND 12-Item Health Survey (RAND-12)

    Five Years

  • RAND-12

    One years

  • +8 more secondary outcomes

Study Arms (2)

Ceramic on Ceramic

ACTIVE COMPARATOR

Subjects received a ceramic on ceramic bearing total hip replacement.

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

Ceramic-on-Highly Crosslinked Polyethylene

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

Interventions

Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper headDEVICE
Ceramic on Ceramic
Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper headDEVICE
Ceramic-on-Highly Crosslinked Polyethylene

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

Study Officials

  • Lauren Beaupre, PT, PhD

    University of Alberta

    STUDY DIRECTOR

  • D William C Johnston, MD, FRCS (C)

    Alberta Health services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 31, 2012

Study Start

November 1, 1997

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

CA(2)