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Hip OsteoarthritisNCT03558217

Collared Versus Collarless Femoral Implants for Total Hip Arthroplasty

A study testing Collared Femoral Implant and Collarless Femoral Implant in people with Hip Osteoarthritis and Hip Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Osteoarthritis, Hip Arthroplasty
What is being tested?
Collared Femoral Implant and Collarless Femoral Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteCanada
Study dates
15 Jan 2018to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • unilateral hip osteoarthritis
  • primary total hip arthroplasty

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • London Health Sciences Centre

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Collared Femoral Implant, Collarless Femoral Implant
Keywords
total hip arthroplasty, collarless femoral implant, collared femoral implant, direct anterior approach, direct lateral approach
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collared Femoral ImplantDevice

    Corail collared femoral implant for total hip arthroplasty

  • Collarless Femoral ImplantDevice

    Corail collarless femoral implant for total hip arthroplasty

Study groups in NCT03558217
Study groupRoleWhat they receive
Collared Femoral ImplantExperimentalParticipants will have the Corail collared femoral implant used during their surgery.
Receives: Device: Collared Femoral Implant
Collarless Femoral ImplantActive comparatorParticipants will have the Corail collarless femoral implant used during their surgery.
Receives: Device: Collarless Femoral Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant Migration

    Movement of the implant measured by radiostereometric imaging analysis.

    Measured: 2 years

Secondary outcomes (8)
  1. Timed-Up-and-Go (TUG) Test

    Measure to assess function.

    Measured: baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years

  2. Activity Level

    Activity measured by number of steps taken per day with the use of a FitBit.

    Measured: baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years

  3. University of California, Los Angeles (UCLA) Activity Score

    Patient-reported outcome to assess activity level.

    Measured: baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years

  4. 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.

    Measured: baseline and 3 months, 6 months, 1 year and 2 years

  5. 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.

    Measured: baseline and 3 months, 6 months, 1 year and 2 years

  6. 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.

    Measured: baseline and 3 months, 6 months, 1 year and 2 years.

  7. EuroQol-5D (EQ-5D)

    Used to assess health-related quality of life. Patient-reported measure to assess quality of life.

    Measured: baseline and 6 weeks, 3 months, 6 months and 1 year

  8. 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.

    Measured: 6 weeks, 3 months, 6 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start15 Jan 2018
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to have either the collared or collarless Corail femoral implant used during surgery and randomization will be stratified by surgical approach (determined by surgeon expertise).
Masking
Single blind
Who is masked
Participant
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03558217
Sponsor's protocol ID
109401
Status last verified
Feb 2022
First submitted
17 Nov 2017
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Polus JS, Vasarhelyi EM, Lanting BA, Teeter MG. Acetabular cup fixation with and without screws following primary total hip arthroplasty: migration evaluated by radiostereometric analysis. Hip Int. 2024 Jan;34(1):42-48. doi: 10.1177/11207000231164711. Epub 2023 Apr 5.

    PubMed 37016808

Questions about this trial

What is this clinical trial studying?

A study testing Collared Femoral Implant and Collarless Femoral Implant in people with Hip Osteoarthritis and Hip Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Migration (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03558217, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.

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