Corail Stability at 5-Years Post-Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

5 Year Migration of Collared or Collarless Corail Stems Following THA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893563
• Other study ID #: 13405
• Status: Recruiting
• Start date: October 2, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Brent Lanting
• Phone: 519-663-3335
• Email: brent.lanting[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participated in the originally investigated cohort.

• Minimum of 4-5 years post-operation

Exclusion Criteria:

• Pregnancy

• Unable to attend follow-up

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

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).
• 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.

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Migration	Measure implant migration that has occurred up until 5-years post-operation using RSA.	at 5-years post-THA
Secondary	WOMAC Score	Assess the WOMAC clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.	at 5-years post-THA
Secondary	SF12 Score	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.	at 5-years post-THA
Secondary	HSS Score	Assess the HHS clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.	at 5-years post-THA
Secondary	UCLA Score	Assess the UCLA clinical outcome questionnaire of the originally investigated cohort at 5 years post-operation compared to pre-surgery and early post-surgery.	at 5-years post-THA
Secondary	Inducible Displacement	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.	at 5-years post-THA
Secondary	Joint Imaging Features	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.	at 5-years post-THA
Secondary	Gut Microbiome Analysis	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.	at 5-years post-THA