Comparison of Two Hydroxy-apatite Coated Hip Stems

Canadian Radiostereometric Analysis Network

Status: Completed

Conditions: Hip Osteoarthritis

Treatments: Device: Avenir cementless hip stem; Device: Corail HA-coated hip stem

Study type: Interventional

Funder types: Other

Identifiers

NCT03577522

B2018-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Avenir cementless hip stem

Active Comparator group

Description:

Total hip arthroplasty: Avenir vs Corail

Treatment:

Device: Avenir cementless hip stem

Corail HA-coated hip stem

Active Comparator group

Description:

Total hip arthroplasty: Corail vs Avenir

Treatment:

Device: Corail HA-coated hip stem