NCT05893563

Corail Stability at 5-Years Post-Total Hip Arthroplasty

5 Year Migration of Collared or Collarless Corail Stems Following THA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2023-06-08
• Last updated: 2025-04-09

Locations

1 site across 1 country: Canada