Clinical trial NCT05877261: Cementless Triathlon 5YR Follow-Up
Official title: 5 Year Follow-Up of Migration of a Cementless Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty, Total
Knee Osteoarthritis
Radiostereometric Analysis
Keywords: Osteoarthritis
Cementless Fixation
Gut Microbiome
Weight-Bearing Computed Tomography
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Schulich School of Medicine and Dentistry
First posted: 2023-05-26
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Implant Migration (tibial component)
timeFrame: 5 year follow-up
Secondary outcomes:
measure: Implant Migration (femoral component)
timeFrame: 5 year follow-up
measure: Inducible Displacement (RSA-based)
timeFrame: 5 year follow-up
measure: Inducible Displacement (CT-based)
timeFrame: 5 year follow-up
measure: Bone Density
timeFrame: 5 year follow-up
measure: Texture Features
timeFrame: 5 year follow-up
measure: Microbial Diversity
timeFrame: 5 year follow-up
Other outcomes:
measure: 12-Item Short Form Survey (SF-12)
timeFrame: 5 year follow-up
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 5 year follow-up
measure: Knee Society Score (KSS)
timeFrame: 5 year follow-up
measure: UCLA Activity Score
timeFrame: 5 year follow-up
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: Schulich School of Medicine and Dentistry
name: Brent Lanting, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Canadian Joint Replacement Registry. Hip and Knee Replacements in Canada: CJRR Annual Statistics Summary, 2018-2019.; 2019.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.