Comparison of Two Hydroxy-apatite Coated Hip Stems

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577522
• Other study ID #: B2018-031
• Status: Completed
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Canadian Radiostereometric Analysis Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 30, 2024
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Avenir cementless hip stem
Avenir cementless hip stem vs Corail HA-coated hip stem
• Corail HA-coated hip stem
Avenir cementless hip stem vs Corail HA-coated hip stem

Locations

Country	Name	City	State
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Radiostereometric Analysis Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration	Measured via radiosteriometric analysis	2 years