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Knee Arthroplasty, TotalNCT05877261

Cementless Triathlon 5YR Follow-Up

An observational study of Knee Arthroplasty, Total and Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
Cementless Total Knee Replacement
Type of treatment
Medical device
How many people
18 participants
Where
1 siteCanada
Study dates
25 May 2023to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Pregnancy
  • Unable to follow-up

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Hospital

    London, Ontario, N6A5A5

Other trials in Canada

About this study

Official title: 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.

Being tested
Cementless Total Knee Replacement
Keywords
Osteoarthritis, Cementless Fixation, Gut Microbiome, Weight-Bearing Computed Tomography
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cementless Total Knee ReplacementDevice

    Artificial knee implant inserted by cementless fixation.

Study groups in NCT05877261
Study groupRoleWhat they receive
Prior Cementless Knee Replacement CohortPatients who received a cementless knee replacement in 2017-2018 and participated in a prior study measuring the first year of implant migration.
Receives: Device: Cementless Total Knee Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant Migration (tibial component)

    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.

    Measured: 5 year follow-up

Secondary outcomes (6)

  1. Implant Migration (femoral component)

    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.

    Measured: 5 year follow-up

  2. Inducible Displacement (RSA-based)

    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.

    Measured: 5 year follow-up

  3. Inducible Displacement (CT-based)

    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.

    Measured: 5 year follow-up

  4. Bone Density

    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.

    Measured: 5 year follow-up

  5. Texture Features

    Weight-bearing computed tomography (CT) texture analysis will be performed in standardized volumes of interest below the pegs and keel of the tibial component.

    Measured: 5 year follow-up

  6. Microbial Diversity

    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.

    Measured: 5 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start25 May 2023
  3. Primary completion1 Apr 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877261
Sponsor's protocol ID
12925
Status last verified
Mar 2025
First submitted
4 Apr 2023
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siddiqi A, Levine BR, Springer BD. Highlights of the 2021 American Joint Replacement Registry Annual Report. Arthroplast Today. 2022 Jan 29;13:205-207. doi: 10.1016/j.artd.2022.01.020. eCollection 2022 Feb. No abstract available.

    PubMed 35128013

  • Cherian JJ, Banerjee S, Kapadia BH, Jauregui JJ, Harwin SF, Mont MA. Cementless total knee arthroplasty: a review. J Knee Surg. 2014 Jun;27(3):193-7. doi: 10.1055/s-0034-1374811. Epub 2014 Apr 24.

    PubMed 24764231

  • Nam D, Lawrie CM, Salih R, Nahhas CR, Barrack RL, Nunley RM. Cemented Versus Cementless Total Knee Arthroplasty of the Same Modern Design: A Prospective, Randomized Trial. J Bone Joint Surg Am. 2019 Jul 3;101(13):1185-1192. doi: 10.2106/JBJS.18.01162.

    PubMed 31274720

  • Nam D, Bhowmik-Stoker M, Mahoney OM, Dunbar MJ, Barrack RL. Mid-Term Performance of the First Mass-Produced Three-Dimensional Printed Cementless Tibia in the United States as Reported in the American Joint Replacement Registry. J Arthroplasty. 2023 Jan;38(1):85-89. doi: 10.1016/j.arth.2022.07.020. Epub 2022 Aug 5.

    PubMed 35934187

  • Valstar ER, Nelissen RG, Reiber JH, Rozing PM. The use of Roentgen stereophotogrammetry to study micromotion of orthopaedic implants. ISPRS journal of photogrammetry and remote sensing 2002;56(5):376-89.

  • Canadian Joint Replacement Registry. Hip and Knee Replacements in Canada: CJRR Annual Statistics Summary, 2018-2019.; 2019.

  • Pijls BG, Plevier JWM, Nelissen RGHH. RSA migration of total knee replacements. Acta Orthop. 2018 Jun;89(3):320-328. doi: 10.1080/17453674.2018.1443635. Epub 2018 Mar 6.

    PubMed 29508661

  • Williams HA, Broberg JS, Howard JL, Lanting BA, Teeter MG. Effect of gap balancing and measured resection techniques on implant migration and contact kinematics of a cementless total knee arthroplasty. Knee. 2021 Aug;31:86-96. doi: 10.1016/j.knee.2021.05.011. Epub 2021 Jun 10.

    PubMed 34119998

  • Broden C, Sandberg O, Olivecrona H, Emery R, Skoldenberg O. Precision of CT-based micromotion analysis is comparable to radiostereometry for early migration measurements in cemented acetabular cups. Acta Orthop. 2021 Aug;92(4):419-423. doi: 10.1080/17453674.2021.1906082. Epub 2021 Apr 6.

    PubMed 33821746

  • Das M, Cronin O, Keohane DM, Cormac EM, Nugent H, Nugent M, Molloy C, O'Toole PW, Shanahan F, Molloy MG, Jeffery IB. Gut microbiota alterations associated with reduced bone mineral density in older adults. Rheumatology (Oxford). 2019 Dec 1;58(12):2295-2304. doi: 10.1093/rheumatology/kez302.

    PubMed 31378815

  • Ma R, Wu M, Li Y, Wang J, Yang P, Chen Y, Wang W, Song J, Wang K. The use of bone turnover markers for monitoring the treatment of osteoporosis in postmenopausal females undergoing total knee arthroplasty: a prospective randomized study. J Orthop Surg Res. 2021 Mar 17;16(1):195. doi: 10.1186/s13018-021-02343-3.

    PubMed 33731168

  • Al KF, Bisanz JE, Gloor GB, Reid G, Burton JP. Evaluation of sampling and storage procedures on preserving the community structure of stool microbiota: A simple at-home toilet-paper collection method. J Microbiol Methods. 2018 Jan;144:117-121. doi: 10.1016/j.mimet.2017.11.014. Epub 2017 Nov 16.

    PubMed 29155236

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Arthroplasty, Total and Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Migration (tibial component) (time frame: 5 year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05877261, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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