Cementless Triathlon 5YR Follow-Up

NCT05877261 | Completed

• 1 other identifier: 12925
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty, Total; Knee Osteoarthritis; Radiostereometric Analysis

Keywords

Osteoarthritis; Cementless Fixation; Gut Microbiome; Weight-Bearing Computed Tomography

Outcome Measures

Primary Outcomes (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.

  5 year follow-up

Secondary Outcomes (6)

• Implant Migration (femoral component)

  5 year follow-up

• Inducible Displacement (RSA-based)

  5 year follow-up

• Inducible Displacement (CT-based)

  5 year follow-up

• Bone Density

  5 year follow-up

• Texture Features

  5 year follow-up

Other Outcomes (4)

• 12-Item Short Form Survey (SF-12)

  5 year follow-up

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  5 year follow-up

• Knee Society Score (KSS)

  5 year follow-up

Study Arms (1)

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

Interventions

Cementless Total Knee Replacement DEVICE

Artificial knee implant inserted by cementless fixation.

Prior Cementless Knee Replacement Cohort

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Unable to follow-up

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Schulich School of Medicine and Dentistry: collaborator

Study Sites (1)

University Hospital

London, Ontario, N6A5A5, Canada

Location

Related Publications (12)

• 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.

  PMID: 35128013 BACKGROUND

• 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.

  PMID: 24764231 BACKGROUND

• 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.

  PMID: 31274720 BACKGROUND

• 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.

  PMID: 35934187 BACKGROUND

• 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.

  BACKGROUND

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

  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.

  PMID: 29508661 BACKGROUND

• 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.

  PMID: 34119998 BACKGROUND

• 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.

  PMID: 33821746 BACKGROUND

• 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.

  PMID: 31378815 BACKGROUND

• 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.

  PMID: 33731168 BACKGROUND

• 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.

  PMID: 29155236 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Microbial DNA will be extracted from stool samples for 16s rRNA sequencing.

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brent Lanting, MD MSc FRCSC

  Schulich School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 26, 2023
• Study Start: May 25, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)