Collared Versus Collarless Femoral Implants for Total Hip Arthroplasty

Comparing Direct Anterior and Lateral Surgical Approaches for Collared and Collarless Implants and Correlating Joint Motion to Hip Implant Performance

This is a randomized control trial that will investigate whether a collared hip replacement implant provides greater stability compared to a collarless option. Stability will be measured by implant migration with radiostereometric analysis (RSA) imaging. Secondary objectives will be to compare function, quality of life and cost between the two implant types. We will also compare between two different surgical approaches, the direct anterior and direct lateral.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis; Hip Arthroplasty
• Intervention / Treatment: Device: Collared Femoral Implant; Device: Collarless Femoral Implant

Detailed Description

Total hip arthroplasty (THA) is a procedure that has been demonstrated to provide excellent patient satisfaction and improve quality of life while being cost effective. The number of THA's conducted worldwide is expected to continue to grow; in some projections to grow exponentially. However, the environment for health care continues to evolve. Patients continue to demand higher activity levels, decreased recovery times, and greater patient autonomy. Health care economics are increasingly influencing clinical decision making. Bundled health care payments and more stringent evaluations are becoming the norm. Changes in care pathways based on patient input as well as due to health care economics are our new reality.

These two pervasive forces of change have led to a variety of care challenges and thought leaders have proposed solutions to these challenges. One solution that has responded to both changing patient expectations in their THA experience as well as the economic pressures has been rapid recovery pathways. An increase in rapid recovery care pathways and the growing prevalence of outpatient surgery and surgi-centers has enabled patients to increase their autonomy as well as decrease their time away from activities that are important to them such as employment. Rapid recovery care pathways also provide substantial cost savings by diminishing or eliminating inpatient care as well as enabling improved bed management options.

To facilitate rapid recovery programs, a variety of surgical changes have been made. Improved peri-operative care, decreased muscle trauma, improved hemostasis, and multi-modal analgesia have all made positive impacts. The increasing adaptation of the Direct Anterior Approach (DAA) relative to the Direct Lateral Approach (DLA) can be seen as a response to the need for rapid recovery programs as DAA has been demonstrated to enable earlier function and is thought to result in better patient outcomes, less pain, and shorter recovery times. Orthopaedic industry partners have also supported this change in practice by providing improved instrumentation and technologies to potentiate this minimal invasive surgical approach. A key change is the increasing use of implants that facilitate muscle sparing approaches: femoral components that do no require straight femoral reamers as well as broaches and implants with design features such as an angled lateral shoulder, abbreviated stem lengths, easy to control stem tips, and stems that do not require aggressive impaction to create intimate cortical contact. The Corail both has these features that potentiate surgery as well as excellent survivorship on registry and prospective studies.

In addition to the design features that potentiate minimally invasive implantation, the Corail stem has two main designs - the collared and collarless versions. Without question, the collar provides improved axial stability, and it has also been shown to provide improved rotational stability. It is unclear if this stability enables improved early function by providing the patient the sense that their implant is more stable immediately after surgery. Clinicians also appreciate the ability to more precisely control leg length during THA by ensuring the appropriate leg length is maintained when the collar abuts the calcar. The collar is felt to enable greater initial stability to the hip and provide the surgeon with greater confidence that the patient can embark on a rapid recovery care pathway.

However, not all surgeons are as supportive of implants that have a collar nor are they supportive of implants that have a collar, and highlight a lack of literature that is able to demonstrate the benefits. A lack of literature makes it a challenge for surgeons to adopt the change in philosophy. The purpose of this study is to examine the role of surgical approach and implant design on activity and implant fixation following THA.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral hip osteoarthritis
• primary total hip arthroplasty

Exclusion Criteria:

• symptomatic osteoarthritis in the contralateral hip
• bilateral total hip arthroplasty
• revision arthroplasty
• cognitive defects/neuromuscular disorders
• inability to understand English (questionnaires are only provided in English)
• live more than 100km from London, Ontario
• BMI greater than 40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collared Femoral Implant; Participants will have the Corail collared femoral implant used during their surgery.	Device: Collared Femoral Implant; Corail collared femoral implant for total hip arthroplasty
Active Comparator: Collarless Femoral Implant; Participants will have the Corail collarless femoral implant used during their surgery.	Device: Collarless Femoral Implant; Corail collarless femoral implant for total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Migration	Movement of the implant measured by radiostereometric imaging analysis.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed-Up-and-Go (TUG) Test	Measure to assess function.	baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years
Activity Level	Activity measured by number of steps taken per day with the use of a FitBit.	baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years
University of California, Los Angeles (UCLA) Activity Score	Patient-reported outcome to assess activity level.	baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years
12-Item Short Form Health Survey (SF-12)	General health questionnaire. Patient-reported measure to assess quality of life. Scores are calculated based on population averages.	baseline and 3 months, 6 months, 1 year and 2 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Used to assess impact of hip and knee osteoarthritis. Patient-reported measure to assess function, pain and stiffness. Higher scores indicate worse pain, stiffness and functional limitations. Scores are separated into 3 subscales: pain, stiffness and function; but can be combined for a total score.	baseline and 3 months, 6 months, 1 year and 2 years
Harris Hip Score	Used to assess impact of hip osteoarthritis. Clinician-reported outcome measure to assess function, pain and range of motion. Higher scores indicate better outcomes and hip function.	baseline and 3 months, 6 months, 1 year and 2 years.
EuroQol-5D (EQ-5D)	Used to assess health-related quality of life. Patient-reported measure to assess quality of life.	baseline and 6 weeks, 3 months, 6 months and 1 year
Cost Questionnaires	Patient-reported measure to assess indirect and direct costs of treatment including ER visits, clinician visits, tests and procedures, lost productivity, caregiver involvement, etc.	6 weeks, 3 months, 6 months and 1 year

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Brent A Lanting, MD, FRCSC, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: total hip arthroplasty; collarless femoral implant; collared femoral implant; direct anterior approach; direct lateral approach
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 109401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No