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Completed

NCT Number: NCT03577522

Comparison of Two Hydroxy-apatite Coated Hip Stems

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

About this study

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:

  • Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Avenir cementless hip stem

Device

Avenir cementless hip stem vs Corail HA-coated hip stem

Corail HA-coated hip stem

Device

Avenir cementless hip stem vs Corail HA-coated hip stem

Primary outcomes

  1. Migration

    Time frame: 2 years

    Measured via radiosteriometric analysis

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jul 5, 2018
Registry last updated
Dec 4, 2025

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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