Comparison of Two Hydroxy-apatite Coated Hip Stems
- Conditions
- Hip Osteoarthritis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Migration 2 years Measured via radiosteriometric analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada
Concordia Hospital🇨🇦Winnipeg, Manitoba, Canada