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OpenTrials
Completed

NCT Number: NCT05893563

Corail Stability at 5-Years Post-Total Hip Arthroplasty

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Science Centre

London, Ontario, N6A5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Unable to attend follow-up

Treatment and study plan

Standard Post-Operative Clinic Visit

Other

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).

Study-Specific Outcomes

Other

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.

Primary outcomes

  1. 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

  1. WOMAC Score

    Time frame: at 5-years post-THA

    Assess the WOMAC clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.

  2. SF12 Score

    Time frame: at 5-years post-THA

    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.

  3. HSS Score

    Time frame: at 5-years post-THA

    Assess the HHS clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.

  4. UCLA Score

    Time frame: at 5-years post-THA

    Assess the UCLA clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.

  5. Inducible Displacement

    Time frame: at 5-years post-THA

    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.

  6. Joint Imaging Features

    Time frame: at 5-years post-THA

    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.

  7. Gut Microbiome Analysis

    Time frame: at 5-years post-THA

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

5 Year Migration of Collared or Collarless Corail Stems Following THA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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