Comparison of Two Hydroxy-apatite Coated Hip Stems

Not Applicable

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Device: Avenir cementless hip stem; Device: Corail HA-coated hip stem

• Registration Number: NCT03577522
• Lead Sponsor: Canadian Radiostereometric Analysis Network

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.

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-05
• Study Start: 2018-07-19
• Primary Completion: 2023-02-09
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avenir cementless hip stem	Avenir cementless hip stem	Total hip arthroplasty: Avenir vs Corail
Corail HA-coated hip stem	Corail HA-coated hip stem	Total hip arthroplasty: Corail vs Avenir

Primary Outcome Measures

Name	Time	Method
Migration	2 years	Measured via radiosteriometric analysis

Trial Locations

Locations (1)

Concordia Hospital; 🇨🇦 Winnipeg, Manitoba, Canada