Comparison of Two Hydroxy-apatite Coated Hip Stems

February 5, 2024 updated by: Canadian Radiostereometric Analysis Network

Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis

In this study, the investigators propose to randomize 80 subjects to receive either the Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and follow these patients for a period of 2 years post-surgery. The investigators aim to determine if the Avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized controlled trial of patients undergoing primary total hip arthroplasty. This study will be focused on enrollment at a single site with possible expansion to additional centers should patient enrollment occur at a slower than expected rate. Decision to expand the study to additional centers will be mutually agreed upon by both the clinical site and the study sponsor.

Patients will be randomized to two study groups:

  1. Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup;
  2. DePuy-Synthes Corail cementless, HA-coated, non-collared femoral hip stem with matching Pinnacle cup Patient allocation to the study groups will occur following a randomized 4-block design.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Concordia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Symptomatic osteoarthritis of the hip undergoing primary total hip arthroplasty
  • Between the ages of 18 and 79 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion Criteria

  • Requires specialty implant (e.g., suspected metal allergy, coxa vera implant)
  • Avascular necrosis
  • Unresolved infection of the hip
  • Hip fracture
  • Hip dysplasia
  • At risk for loss to follow-up
  • Prior surgery to the ipsilateral hip
  • Severe proximal femoral deformity preventing the use of standard proximal press-fit femoral components
  • Medical condition precluding major surgery
  • Current or pending patient incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Avenir cementless hip stem
Total hip arthroplasty: Avenir vs Corail
Device: Avenir cementless hip stem
Avenir cementless hip stem vs Corail HA-coated hip stem
Active Comparator: Corail HA-coated hip stem
Total hip arthroplasty: Corail vs Avenir
Device: Corail HA-coated hip stem
Avenir cementless hip stem vs Corail HA-coated hip stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migration
Time Frame: 2 years
Measured via radiosteriometric analysis
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Radiostereometric Analysis Network

Investigators

  • Principal Investigator: Thomas Turgeon, MD, Concordia Joint Replacement Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2018

Primary Completion (Actual)

February 9, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2018-031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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