Clinical trial NCT05893563: Corail Stability at 5-Years Post-Total Hip Arthroplasty
Official title: 5 Year Migration of Collared or Collarless Corail Stems Following THA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Keywords: Implant Migration
Radiostereometric Analysis
CT Imaging
Microbiome
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously recruited to a prospective RCT (NCT03558217), will be eligible to participate in this study. These patients were recruited preoperatively and underwent total hip arthroplasty using either the direct anterior or the direct lateral surgical approach. Each patient was also randomized to either receive a collared or collarless stem design. In the original study, patients were followed up until two-years postoperation, where the primary outcome measure was implant migration compared between surgical approach and implant design.

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.


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

Primary outcomes:
measure: Implant Migration
timeFrame: at 5-years post-THA
Secondary outcomes:
measure: WOMAC Score
timeFrame: at 5-years post-THA
measure: SF12 Score
timeFrame: at 5-years post-THA
measure: HSS Score
timeFrame: at 5-years post-THA
measure: UCLA Score
timeFrame: at 5-years post-THA
measure: Inducible Displacement
timeFrame: at 5-years post-THA
measure: Joint Imaging Features
timeFrame: at 5-years post-THA
measure: Gut Microbiome Analysis
timeFrame: at 5-years post-THA
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
Study officials:
affiliation: Lawson Health Science Centre
name: Brent Lanting
role: PRINCIPAL_INVESTIGATOR
References: