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Corail Stability at 5-Years Post-Total Hip Arthroplasty

5 Year Migration of Collared or Collarless Corail Stems Following THA

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05893563
Enrollment
48
Registered
2023-06-08
Start date
2023-10-02
Completion date
2024-02-26
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty

Keywords

Implant Migration, Radiostereometric Analysis, CT Imaging, Microbiome

Brief 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. 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.

Interventions

OTHERStandard Post-Operative Clinic Visit

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).

OTHERStudy-Specific Outcomes

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.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Participated in the originally investigated cohort. * Minimum of 4-5 years post-operation

Exclusion criteria

* Pregnancy * Unable to attend follow-up

Design outcomes

Primary

MeasureTime frameDescription
Implant Migrationat 5-years post-THAMeasure implant migration that has occurred up until 5-years post-operation using RSA.

Secondary

MeasureTime frameDescription
SF12 Scoreat 5-years post-THAAssess the SF-12 clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
HSS Scoreat 5-years post-THAAssess the HHS clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
UCLA Scoreat 5-years post-THAAssess the UCLA clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
WOMAC Scoreat 5-years post-THAAssess the WOMAC clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
Joint Imaging Featuresat 5-years post-THACorrelate 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.
Gut Microbiome Analysisat 5-years post-THACorrelate 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.
Inducible Displacementat 5-years post-THACompare 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026