Cementless Triathlon 5YR Follow-Up

NCT ID: NCT05877261

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-25

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Knee Arthroplasty, Total Knee Osteoarthritis Radiostereometric Analysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Cementless Total Knee Replacement

Intervention Type DEVICE

Artificial knee implant inserted by cementless fixation.

Interventions

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Cementless Total Knee Replacement

Artificial knee implant inserted by cementless fixation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulich School of Medicine and Dentistry

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Brent Lanting

Orthopaedic Surgeon, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brent Lanting, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

Schulich School of Medicine and Dentistry

Locations

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University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 35128013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24764231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31274720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35934187 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29508661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34119998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33821746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31378815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33731168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29155236 (View on PubMed)

Other Identifiers

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12925

Identifier Type: -

Identifier Source: org_study_id

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