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.
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.
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.
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty
- 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 group | Role | What they receive |
|---|---|---|
| Collared Femoral Implant | Experimental | Participants will have the Corail collared femoral implant used during their surgery. Receives: Device: Collared Femoral Implant |
| Collarless Femoral Implant | Active comparator | Participants 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.
Implant Migration
Movement of the implant measured by radiostereometric imaging analysis.
Measured: 2 years
Secondary outcomes (8)
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
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
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
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
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
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.
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
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.
- First posted15 Jun 2018
- Study start15 Jan 2018
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brent A Lanting, MD, FRCSC, Principal investigator, London Health Sciences Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Direct Anterior and Lateral Surgical Approaches for Collared and Collarless Implants and Correlating Joint Motion to Hip Implant Performance
- ClinicalTrials.gov ID
- NCT03558217
- Acronym / sponsor ID
- 109401
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty
- Keywords
- total hip arthroplasty, collarless femoral implant, collared femoral implant, direct anterior approach, direct lateral approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Collared Femoral Implant | Experimental | Device: Collared Femoral ImplantParticipants will have the Corail collared femoral implant used during their surgery. |
| Collarless Femoral Implant | Active comparator | Device: Collarless Femoral ImplantParticipants will have the Corail collarless femoral implant used during their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral hip osteoarthritis
- primary total hip arthroplasty
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collared Femoral ImplantCorail collared femoral implant for total hip arthroplasty | Device | Collared Femoral Implant |
| Collarless Femoral ImplantCorail collarless femoral implant for total hip arthroplasty | Device | Collarless Femoral Implant |
Primary outcome
Implant Migration
Time frame: 2 years
Movement of the implant measured by radiostereometric imaging analysis.
8 secondary outcomes
Timed-Up-and-Go (TUG) Test
Time frame: baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years
Activity Level
Time frame: 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
Time frame: 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)
Time frame: baseline and 3 months, 6 months, 1 year and 2 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline and 3 months, 6 months, 1 year and 2 years
Harris Hip Score
Time frame: baseline and 3 months, 6 months, 1 year and 2 years.
EuroQol-5D (EQ-5D)
Time frame: baseline and 6 weeks, 3 months, 6 months and 1 year
Cost Questionnaires
Time frame: 6 weeks, 3 months, 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 37016808Polus 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.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
Active, not recruiting
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A Lanting, MD, FRCSC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
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.