Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-31 @ 4:14 PM
Study NCT ID:
NCT05877261
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2023-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cementless Triathlon 5YR Follow-Up
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
5 Year Follow-Up of Migration of a Cementless Total Knee Replacement
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: