Corail Stability at 5-Years Post-Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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5 Year Migration of Collared or Collarless Corail Stems Following THA

Conditions
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Total Hip Arthroplasty

Intervention / Treatment
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* Other: Standard Post-Operative Clinic Visit
* Other: Study-Specific Outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in the originally investigated cohort. Minimum of 4-5 years post-operation Exclusion Criteria: Pregnancy Unable to attend follow-up
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Direct Anterior<br>Patients who underwent the Direct Anterior (DA) surgical approach | Other: Standard Post-Operative Clinic Visit<br>* 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).<br>Other: Study-Specific Outcomes<br>* 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.<br>|
| Direct Lateral<br>Patients who underwent the Direct Lateral (DL) surgical approach | Other: Standard Post-Operative Clinic Visit<br>* 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).<br>Other: Study-Specific Outcomes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Migration | Measure implant migration that has occurred up until 5-years post-operation using RSA. | at 5-years post-THA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | at 5-years post-THA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implant Migration, Radiostereometric Analysis, CT Imaging, Microbiome