Corail Stability at 5-Years Post-Total Hip Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Direct Anterior Patients who underwent the Direct Anterior (DA) surgical approach |
Other: Standard 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).
Other: Study-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.
|
| Direct Lateral Patients who underwent the Direct Lateral (DL) surgical approach |
Other: Standard 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).
Other: Study-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.
|
Outcome Measures
Primary Outcome Measures
- Implant Migration [at 5-years post-THA]
Measure implant migration that has occurred up until 5-years post-operation using RSA.
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participated in the originally investigated cohort.
-
Minimum of 4-5 years post-operation
Exclusion Criteria:
-
Pregnancy
-
Unable to attend follow-up
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Brent Lanting, Lawson Health Science Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13405