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Corail Stability at 5-Years Post-Total Hip Arthroplasty

NCT05893563 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2025-04-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Brent Lanting · Lawson Health Science Centre

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2024-02-26
Completion
2024-02-26

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05893563 on ClinicalTrials.gov