Comparison of Two Hydroxy-apatite Coated Hip Stems

NCT ID: NCT03577522

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2024-01-30

Brief Summary

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.

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.

Conditions

Hip Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Avenir cementless hip stem

Total hip arthroplasty: Avenir vs Corail

Group Type: ACTIVE_COMPARATOR

Avenir cementless hip stem

Intervention Type: DEVICE

Avenir cementless hip stem vs Corail HA-coated hip stem

Corail HA-coated hip stem

Total hip arthroplasty: Corail vs Avenir

Group Type: ACTIVE_COMPARATOR

Corail HA-coated hip stem

Intervention Type: DEVICE

Avenir cementless hip stem vs Corail HA-coated hip stem

Interventions

Avenir cementless hip stem

Avenir cementless hip stem vs Corail HA-coated hip stem

Intervention Type: DEVICE

Corail HA-coated hip stem

Avenir cementless hip stem vs Corail HA-coated hip stem

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Radiostereometric Analysis Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Turgeon, MD

Role: PRINCIPAL_INVESTIGATOR

Concordia Joint Replacement Group

Locations

Concordia Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2018-031

Identifier Type: -

Identifier Source: org_study_id