Cementless Triathlon 5YR Follow-Up

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877261
• Other study ID #: 12925
• Status: Recruiting
• Start date: May 25, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: Brent Lanting, MD MSc FRCSC
• Phone: 519-685-8500
• Email: Brent.Lanting[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total
• Knee Osteoarthritis
• Osteoarthritis
• Radiostereometric Analysis

Intervention

Device:
• Cementless Total Knee Replacement
Artificial knee implant inserted by cementless fixation.

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Schulich School of Medicine and Dentistry

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	12-Item Short Form Survey (SF-12)	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
Other	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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
Other	Knee Society Score (KSS)	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
Other	UCLA Activity Score	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
Primary	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	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.	5 year follow-up
Secondary	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.	5 year follow-up
Secondary	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.	5 year follow-up
Secondary	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.	5 year follow-up
Secondary	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.	5 year follow-up
Secondary	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.	5 year follow-up