Corail Stability at 5-Years Post-Total Hip Arthroplasty
- Conditions
- Total Hip Arthroplasty
- Interventions
- Other: Standard Post-Operative Clinic VisitOther: Study-Specific Outcomes
- Registration Number
- NCT05893563
- Lead Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Participated in the originally investigated cohort.
- Minimum of 4-5 years post-operation
- Pregnancy
- Unable to attend follow-up
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Direct Anterior Study-Specific Outcomes Patients who underwent the Direct Anterior (DA) surgical approach Direct Lateral Study-Specific Outcomes Patients who underwent the Direct Lateral (DL) surgical approach Direct Anterior Standard Post-Operative Clinic Visit Patients who underwent the Direct Anterior (DA) surgical approach Direct Lateral Standard Post-Operative Clinic Visit Patients who underwent the Direct Lateral (DL) surgical approach
- Primary Outcome Measures
Name Time Method Implant Migration at 5-years post-THA Measure implant migration that has occurred up until 5-years post-operation using RSA.
- Secondary Outcome Measures
Name Time Method WOMAC Score at 5-years post-THA Assess the WOMAC clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
HSS Score at 5-years post-THA Assess the HHS clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
UCLA Score at 5-years post-THA Assess the UCLA clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.
SF12 Score at 5-years post-THA 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.
Inducible Displacement at 5-years post-THA 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.
Joint Imaging Features at 5-years post-THA 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.
Gut Microbiome Analysis at 5-years post-THA 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.
Trial Locations
- Locations (1)
London Health Science Centre
🇨🇦London, Ontario, Canada