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Clinical Trials/NCT05893563
NCT05893563
Completed
Not Applicable

5 Year Migration of Collared or Collarless Corail Stems Following THA

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrollment
48
Locations
1
Primary Endpoint
Implant Migration
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2023
End Date
February 26, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brent Lanting

Orthopaedic Surgeon

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

Eligibility Criteria

Inclusion Criteria

  • Participated in the originally investigated cohort.
  • Minimum of 4-5 years post-operation

Exclusion Criteria

  • Pregnancy
  • Unable to attend follow-up

Outcomes

Primary Outcomes

Implant Migration

Time Frame: at 5-years post-THA

Measure implant migration that has occurred up until 5-years post-operation using RSA.

Secondary Outcomes

  • UCLA Score(at 5-years post-THA)
  • WOMAC Score(at 5-years post-THA)
  • HSS Score(at 5-years post-THA)
  • SF12 Score(at 5-years post-THA)
  • Inducible Displacement(at 5-years post-THA)
  • Joint Imaging Features(at 5-years post-THA)
  • Gut Microbiome Analysis(at 5-years post-THA)

Study Sites (1)

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