Corail Stability at 5-Years Post-Total Hip Arthroplasty

NCT05893563 | Completed

• 1 other identifier: 13405
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

Implant Migration; Radiostereometric Analysis; CT Imaging; Microbiome

Outcome Measures

Primary Outcomes (1)

• Implant Migration

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

  at 5-years post-THA

Secondary Outcomes (7)

• WOMAC Score

  at 5-years post-THA

• SF12 Score

  at 5-years post-THA

• HSS Score

  at 5-years post-THA

• UCLA Score

  at 5-years post-THA

• Inducible Displacement

  at 5-years post-THA

Study Arms (2)

Direct Anterior

Patients who underwent the Direct Anterior (DA) surgical approach

Other: Standard Post-Operative Clinic Visit; Other: Study-Specific Outcomes

Direct Lateral

Patients who underwent the Direct Lateral (DL) surgical approach

Other: Standard Post-Operative Clinic Visit; Other: Study-Specific Outcomes

Interventions

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).

Direct Anterior; Direct Lateral

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.

Direct Anterior; Direct Lateral

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Unable to attend follow-up

Sponsors & Collaborators

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

Study Sites (1)

London Health Science Centre

London, Ontario, N6A5A5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

microbial DNA in stool samples

Study Officials

• Brent Lanting

  Lawson Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 8, 2023
• Study Start: October 2, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)