Cementless Triathlon 5YR Follow-Up

February 23, 2024 updated by: Brent Lanting, Lawson Health Research Institute

5 Year Follow-Up of Migration of a Cementless Total Knee Replacement

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Recruiting
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Brent Lanting, MD MSc FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who received a cementless total knee replacement in 2017-2018 and participated in a previous study measuring the first year of implant migration.

Description

Inclusion Criteria:

  • Were in the originally investigated cohort
  • Had successful imaging at 1-year post-operation
  • Minimum of 5 years post-operation

Exclusion Criteria:

  • Pregnancy
  • Unable to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prior Cementless Knee Replacement Cohort
Patients who received a cementless knee replacement in 2017-2018 and participated in a prior study measuring the first year of implant migration.
Device: Cementless Total Knee Replacement
Artificial knee implant inserted by cementless fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Migration (tibial component)
Time Frame: 5 year follow-up
Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the tibial component during supine exams. Potential tibial component migration between 1 and 5 years post-operation will be measured in millimeters with the use of tibial bone markers.
5 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Migration (femoral component)
Time Frame: 5 year follow-up
Implant movement will be measured with model-based Radiostereometric Analysis (RSA) by registering the location of the femoral component during supine exams. Potential femoral component migration between 1 and 5 years post-operation will be measured in millimeters with the use of femoral bone markers.
5 year follow-up
Inducible Displacement (RSA-based)
Time Frame: 5 year follow-up
Model-based Radiostereometric Analysis (RSA) will be used to register the location of the tibial and femoral components during supine and standing exams. Change in implant position will be measured in millimeters as maximum total point motion (MTPM) between the standing and supine RSA exams.
5 year follow-up
Inducible Displacement (CT-based)
Time Frame: 5 year follow-up
Weight-bearing computed tomography (CT) will be used to register the location of the tibial and femoral components during seated and standing exams. Change in implant position will be measured in millimeters as maximum total point motion (MTPM) between the seated and standing CT exams.
5 year follow-up
Bone Density
Time Frame: 5 year follow-up
Weight-bearing computed tomography (CT) scans will be used to measure bone density as Hounsfield units in standardized volumes of interest below the pegs and keel of the tibial component.
5 year follow-up
Texture Features
Time Frame: 5 year follow-up
Weight-bearing computed tomography (CT) texture analysis will be performed in standardized volumes of interest below the pegs and keel of the tibial component.
5 year follow-up
Microbial Diversity
Time Frame: 5 year follow-up
Participants will provide a stool sample. Microbial DNA will be extracted from the stool samples for 16s rRNA sequencing. Taxonomy will be assigned and functional annotation will be determined.
5 year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-Item Short Form Survey (SF-12)
Time Frame: 5 year follow-up
Patient reported outcome measure observing physical and mental health status of patient. There are 12 questions asking about health (excellent to poor), activity limitations (yes, limited a lot to no, not limited at all), problems with daily activities from physical or emotional health (yes or no), pain interfering with normal work (not at all to extremely), recent positive or negative feelings (all of the time to none of the time), and interference of physical or emotional problems with social activities (all of the time to none of the time). A higher score indicates better physical and mental health function.
5 year follow-up
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 5 year follow-up
Patient reported outcome measure observing physical symptoms following recent knee replacement surgery. Contains 24 questions asking about the amount of pain, stiffness, and activity difficulty (none to extreme). A higher score indicates greater pain, stiffness, and activity difficulty.
5 year follow-up
Knee Society Score (KSS)
Time Frame: 5 year follow-up
Patient reported outcome measure. Contains 5 sections measuring patient symptoms (none to severe), satisfaction (very satisfied to very dissatisfied), expectation (too high to too low), functional activities, and discretionary knee activities. Functional activities are split into walking and standing (with or without aids and the duration), standard activities (no bother to cannot do), and advanced activities (no bother to cannot do). Discretionary knee activities measure difficulty with the three most important activities for the patient (no bother to cannot do). Higher scores indicate greater patient outcomes.
5 year follow-up
UCLA Activity Score
Time Frame: 5 year follow-up
Patient reported outcome measure observing activity level of patient. Contains a 10-level scale with 1 representing a patient who is inactive and dependent on others, to 10 representing a patient who regularly participates in impact sports. A higher score indicates a greater activity level.
5 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Schulich School of Medicine and Dentistry

Investigators

  • Principal Investigator: Brent Lanting, MD MSc FRCSC, Schulich School of Medicine and Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12925

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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