Total Hip ArthroplastyNCT05893563
Corail Stability at 5-Years Post-Total Hip Arthroplasty
An observational study of Total 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
Total hip arthroplasty (THA) is the mainstay, definitive management for end-stage hip osteoarthritis. Despite improvements of surgical and patient factors, prosthesis-related complications continue to increase in number. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Standard Post-Operative Clinic Visit and Study-Specific Outcomes
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2023to 26 Feb 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients previously recruited to a prospective RCT (NCT03558217), will be eligible to participate in this study. These patients were recruited preoperatively and underwent total hip arthroplasty using either the direct anterior or the direct lateral surgical approach. Each patient was also randomized to either receive a collared or collarless stem design. In the original study, patients were followed up until two-years postoperation, where the primary outcome measure was implant migration compared between surgical approach and implant design.
Who may be able to join
- Participated in the originally investigated cohort.
- Minimum of 4-5 years post-operation
Who cannot join
- Pregnancy
- Unable to attend follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5 Year Migration of Collared or Collarless Corail Stems Following THA
Total hip arthroplasty (THA) is the mainstay, definitive management for end-stage hip osteoarthritis. Despite improvements of surgical and patient factors, prosthesis-related complications continue to increase in number. This is contributed to by the greater number of such surgeries being completed, larger proportion of elderly individuals among the population, and younger patient age being offered surgical intervention. Specifically, implant loosening and associated migration, is the pathology most commonly yielding revision surgery. A previous study assessing migration of total hip prostheses found that the greatest degree of migration occurred in the first 2 weeks postoperatively, although implants were considered overall stable 2 year following surgery. Continued evaluation of implant migration at time points further from surgery, specifically at 5 years postoperatively, offers insight into long term complications rates. Assessing implant migration will be completed using various imaging modalities, radiostereometric analysis (RSA) and computed tomography (CT). Comparisons between RSA and CT imaging will allow for greater analysis with regards to characterization of implant migration and associated bony changes. Additionally, an individual's gut microbiome has been shown to correspond to their inflammatory and immune profile. Association between gut microbiome profile and implant migration will be assessed to determine if underlying relationship does exist.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Standard Post-Operative Clinic Visit, Study-Specific Outcomes
- Keywords
- Implant Migration, Radiostereometric Analysis, CT Imaging, Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Post-Operative Clinic VisitOther
In clinic, the joint will be assessed (ROM, stability testing), standard X-rays will be taken of the joint, and patient reported outcomes (questionnaires) will be completed by patient (WOMAC, UCLA, VR12, EQ5D, Oxford Hip).
Study-Specific OutcomesOther
Patients will complete additional questionnaires (SF12 and HHS), will undergo RSA and CT imaging for implant stability analysis, and will provide a stool sample for gut microbiome analysis.
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior | Patients who underwent the Direct Anterior (DA) surgical approach Receives: Other: Standard Post-Operative Clinic Visit; Other: Study-Specific Outcomes | |
| Direct Lateral | Patients who underwent the Direct Lateral (DL) surgical approach Receives: Other: Standard Post-Operative Clinic Visit; Other: Study-Specific Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Migration
Measure implant migration that has occurred up until 5-years post-operation using RSA.
Measured: at 5-years post-THA
Secondary outcomes (7)
WOMAC Score
Assess the WOMAC clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
Measured: at 5-years post-THA
SF12 Score
Assess the SF-12 clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
Measured: at 5-years post-THA
HSS Score
Assess the HHS clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
Measured: at 5-years post-THA
UCLA Score
Assess the UCLA clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
Measured: at 5-years post-THA
Inducible Displacement
Compare the amount of inducible displacement measured between supine and weight bearing RSA and between internal and external rotation CT exams to validate the accuracy and precision of CT for implant migration analysis.
Measured: at 5-years post-THA
Joint Imaging Features
Correlate CT-based measurements of bone density and texture features with the magnitude of implant migration using slicer (slicer.org) software to segment and analyze the CT images.
Measured: at 5-years post-THA
Gut Microbiome Analysis
Correlate gut microbiome biomarkers for osteoporosis with the magnitude of implant migration by analyzing the microbial DNA in stool samples. The Shannon index for microbial diversity will be calculated and then correlated to the magnitude of migration.
Measured: at 5-years post-THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start2 Oct 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
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 Total Hip ArthroplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 48 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 Lanting, Principal investigator, Lawson Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893563
- Sponsor's protocol ID
- 13405
- Status last verified
- Apr 2025
- First submitted
- 21 May 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polus JS, Kaptein BL, Vasarhelyi EM, Lanting BA, Teeter MG. Evaluation of conventional and CT-based radiostereometric analysis for inducible displacement measurements after total hip arthroplasty. J Orthop Res. 2025 Jan;43(1):192-199. doi: 10.1002/jor.25981. Epub 2024 Oct 1.
PubMed 39354712
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Year Migration of Collared or Collarless Corail Stems Following THA
- ClinicalTrials.gov ID
- NCT05893563
- Acronym / sponsor ID
- 13405
- Conditions
- Total Hip Arthroplasty
- Keywords
- Implant Migration, Radiostereometric Analysis, CT Imaging, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 8 Jun 2023 (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.
Total hip arthroplasty (THA) is the mainstay, definitive management for end-stage hip osteoarthritis. Despite improvements of surgical and patient factors, prosthesis-related complications continue to increase in number. This is contributed to by the greater number of such surgeries being completed, larger proportion of elderly individuals among the population, and younger patient age being offered surgical intervention. Specifically, implant loosening and associated migration, is the pathology most commonly yielding revision surgery. A previous study assessing migration of total hip prostheses found that the greatest degree of migration occurred in the first 2 weeks postoperatively, although implants were considered overall stable 2 year following surgery. Continued evaluation of implant migration at time points further from surgery, specifically at 5 years postoperatively, offers insight into long term complications rates. Assessing implant migration will be completed using various imaging modalities, radiostereometric analysis (RSA) and computed tomography (CT). Comparisons between RSA and CT imaging will allow for greater analysis with regards to characterization of implant migration and associated bony changes. Additionally, an individual's gut microbiome has been shown to correspond to their inflammatory and immune profile. Association between gut microbiome profile and implant migration will be assessed to determine if underlying relationship does exist.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior | – | Other: Standard Post-Operative Clinic Visit, Other: Study-Specific OutcomesPatients who underwent the Direct Anterior (DA) surgical approach |
| Direct Lateral | – | Other: Standard Post-Operative Clinic Visit, Other: Study-Specific OutcomesPatients who underwent the Direct Lateral (DL) surgical approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously recruited to a prospective RCT (NCT03558217), will be eligible to participate in this study. These patients were recruited preoperatively and underwent total hip arthroplasty using either the direct anterior or the direct lateral surgical approach. Each patient was also randomized to either receive a collared or collarless stem design. In the original study, patients were followed up until two-years postoperation, where the primary outcome measure was implant migration compared between surgical approach and implant design.
Key inclusion criteria (2 listed)
- Participated in the originally investigated cohort.
- Minimum of 4-5 years post-operation
Key exclusion criteria (2 listed)
- Pregnancy
- Unable to attend follow-up
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 |
|---|---|---|
| Standard Post-Operative Clinic VisitIn clinic, the joint will be assessed (ROM, stability testing), standard X-rays will be taken of the joint, and patient reported outcomes (questionnaires) will be completed by patient (WOMAC, UCLA, VR12, EQ5D, Oxford Hip). | Other | Direct Anterior, Direct Lateral |
| Study-Specific OutcomesPatients will complete additional questionnaires (SF12 and HHS), will undergo RSA and CT imaging for implant stability analysis, and will provide a stool sample for gut microbiome analysis. | Other | Direct Anterior, Direct Lateral |
Primary outcome
Implant Migration
Time frame: at 5-years post-THA
Measure implant migration that has occurred up until 5-years post-operation using RSA.
7 secondary outcomes
WOMAC Score
Time frame: at 5-years post-THA
SF12 Score
Time frame: at 5-years post-THA
HSS Score
Time frame: at 5-years post-THA
UCLA Score
Time frame: at 5-years post-THA
Inducible Displacement
Time frame: at 5-years post-THA
Joint Imaging Features
Time frame: at 5-years post-THA
Gut Microbiome Analysis
Time frame: at 5-years post-THA
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 9 Apr 2025.
- Derived from this study: PubMed 39354712Polus JS, Kaptein BL, Vasarhelyi EM, Lanting BA, Teeter MG. Evaluation of conventional and CT-based radiostereometric analysis for inducible displacement measurements after total hip arthroplasty. J Orthop Res. 2025 Jan;43(1):192-199. doi: 10.1002/jor.25981. Epub 2024 Oct 1.
- Individual participant dataSharing planned: No
Related trials for Total 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 Lanting principal investigator
Lawson Health Science Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total 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 2 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 9 Apr 2025. 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: at 5-years post-THA). 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 NCT05893563, 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 9 Apr 2025.