Weight-Bearing CT and Conventional Periprosthetic Distal Knee Fractures

NCT06909916 | Recruiting

• 1 other identifier: 14154
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is a surgical procedure commonly conducted for patients with end-stage knee osteoarthritis, often leading to improved pain relief and function. However, for patients that have suffered an associated periprosthetic fracture, a broken bone that occurs around the implant of a TKA, they may receive sub-optical care due to a lack of a trustworthy assessments for component fixation and fracture healing in the literature. The prevalence of TKA surgeries is increasing annually and is projected to rise further due to an ageing population and obesity issue. By extension to this primary surgery, more Canadians will require an invasive revision surgery that risks patient morbidity and mortality. Thus, it is imperative to set a standard for fixation and bone healing assessments to lessen revision burdens and improve patient outcomes. CT imaging can effectively visualize areas of incomplete bone ingrowth that may be hidden from overlapping anatomy on plain radiographs, which remains the go-to imaging modality for orthopaedic surgeons to assess periprosthetic fracture healing. The purpose of this prospective cross-sectional study is to examine the efficacy of weight-bearing CT as a diagnostic tool for 20 participants who experienced a distal femur periprosthetic fracture and underwent revision surgery using a fracture fixation plate and screws. Participants will be scanned under loaded and unloaded conditions. Radiographic outcomes will be evaluated, including bone segment displacement and its relation to participants' reports of pain.

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant

Outcome Measures

Primary Outcomes (5)

• Maximum Total Point Motion of Fracture Segments from Conventional CT scans

  Weight-Bearing CT scans of participants will be analyzed for any potential movement between the fracture segments from the identified fracture lines. This will be reported as the maximum total point motion, which refers to the largest observed movement of a point along the fracture line from its initial position.

  1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.

• Maximum Total Point Motion of Fracture Segments from Conventional CT scans

  Conventional CT scans of participants will be analyzed for any potential movement between the fracture segments from the identified fracture lines. This will be reported as the maximum total point motion, which refers to the largest observed movement of a point along the fracture line from its initial position.

  1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire

  This Pain and function questionnaire will be used to assess the pain and ability-to-function of the knee of the participant. This is a participant-reported outcome and it will be compared to the weight-bearing and conventional CT scans.

  1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.

• The Knee Society Score (KSS) Questionnaire

  Knee function and patient outcome questionnaire that will be used to assess the pain and functionality of the knee of the participant. This is a participant-reported outcome and ut will be compared to the weight-bearing and conventional CT scans.

  1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.

• UCLA Activity Score Guideline Questionnaire

  A questionnaire assessing physical activity level from 1 (low) to 10 (high) in patients. It will be used to assess the functionality of the knee of the participant. This is a participant-reported outcome and it will be compared to the weight-bearing and conventional CT scans.

  1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.

Study Arms (1)

Periprosthetic Fracture Knee Repaired

EXPERIMENTAL

The one and only group will be participants that have undergone revision surgery for at least 1\> year prior for their periprosthetic distal knee fracture.

Other: Periprosthetic Fracture Knee Repaired CT Scans

Interventions

Periprosthetic Fracture Knee Repaired CT Scans OTHER

The investigators will be assessing the use of weight-bearing CT and conventional CT, specifically its imaging, with RSA-like software, for analyzing fracture healing for a periprosthetic distal knee fracture.

Periprosthetic Fracture Knee Repaired

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent revision surgery for repair of a distal femur fracture surrounding a primary TKA femoral component using a fracture fixation plate \>1 year
• Age 50-90 years
• Body mass index up to 40kg/m2
• Able to provide informed consent
• Able and willing to do study assessments and follow instructions

You may not qualify if:

• Does not understand English
• Undergone revision surgery for any other indication
• Received Intramedullary nail or distal femur replacement
• Cannot independently stand on one leg in the weight-bearing CT during the inducible displacement exam

Sponsors & Collaborators

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

Study Sites (1)

University Hospital - London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (14)

• Steele JR, Ryan SP, Jiranek WA, Wellman SS, Bolognesi MP, Seyler TM. Cost of Aseptic Revision Total Knee Arthroplasty at a Tertiary Medical Center. J Arthroplasty. 2021 May;36(5):1729-1733. doi: 10.1016/j.arth.2020.11.028. Epub 2020 Dec 17.

  PMID: 33390337 BACKGROUND

• Sinclair ST, Orr MN, Rothfusz CA, Klika AK, McLaughlin JP, Piuzzi NS. Understanding the 30-day mortality burden after revision total knee arthroplasty. Arthroplast Today. 2021 Oct 4;11:205-211. doi: 10.1016/j.artd.2021.08.019. eCollection 2021 Oct.

  PMID: 34660865 BACKGROUND

• Crellin CT, Pennings JS, Engstrom SM, Shinar AA, Polkowski GG, Martin JR. Aseptic tibial loosening: Radiographic identification remains a diagnostic dilemma. Journal of Orthopaedic Reports. 2023;2(4):100194. doi:10.1016/j.jorep.2023.100194

  BACKGROUND

• Wittauer M, Burch MA, McNally M, Vandendriessche T, Clauss M, Della Rocca GJ, Giannoudis PV, Metsemakers WJ, Morgenstern M. Definition of long-bone nonunion: A scoping review of prospective clinical trials to evaluate current practice. Injury. 2021 Nov;52(11):3200-3205. doi: 10.1016/j.injury.2021.09.008. Epub 2021 Sep 10.

  PMID: 34531088 BACKGROUND

• Klug A, Gramlich Y, Rudert M, Drees P, Hoffmann R, Weissenberger M, Kutzner KP. The projected volume of primary and revision total knee arthroplasty will place an immense burden on future health care systems over the next 30 years. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3287-3298. doi: 10.1007/s00167-020-06154-7. Epub 2020 Jul 15.

  PMID: 32671435 BACKGROUND

• Aspinall GA, Dunbar MJ. Assessing clinical results and outcome measures. Surgical Treatment of Hip Arhtritis. 2009;30-36. Doi:10.1016/B978-1-4160-5898-4.00004-5

  BACKGROUND

• Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.

  PMID: 16195075 BACKGROUND

• Rohrl SM. "Great balls on fire:" known algorithm with a new instrument? Acta Orthop. 2020 Dec;91(6):621-623. doi: 10.1080/17453674.2020.1840029. Epub 2020 Nov 4. No abstract available.

  PMID: 33143497 BACKGROUND

• Angelomenos V, Mohaddes M, Itayem R, Shareghi B. Precision of low-dose CT-based micromotion analysis technique for the assessment of early acetabular cup migration compared with gold standard RSA: a prospective study of 30 patients up to 1 year. Acta Orthop. 2022 Apr 22;93:459-465. doi: 10.2340/17453674.2022.2528.

  PMID: 35478261 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

• Stigbrand H, Brown K, Olivecrona H, Ullmark G. Implant migration and bone mineral density measured simultaneously by low-dose CT scans: a 2-year study on 17 acetabular revisions with impaction bone grafting. Acta Orthop. 2020 Oct;91(5):571-575. doi: 10.1080/17453674.2020.1769295. Epub 2020 May 26.

  PMID: 32452289 BACKGROUND

• Eriksson T, Maguire GQ Jr, Noz ME, Zeleznik MP, Olivecrona H, Shalabi A, Hanni M. Are low-dose CT scans a satisfactory substitute for stereoradiographs for migration studies? A preclinical test of low-dose CT scanning protocols and their application in a pilot patient. Acta Radiol. 2019 Dec;60(12):1643-1652. doi: 10.1177/0284185119844166. Epub 2019 May 1. No abstract available.

  PMID: 31042065 BACKGROUND

• Sandberg OH, Karrholm J, Olivecrona H, Rohrl SM, Skoldenberg OG, Broden C. Computed tomography-based radiostereometric analysis in orthopedic research: practical guidelines. Acta Orthop. 2023 Jul 20;94:373-378. doi: 10.2340/17453674.2023.15337.

  PMID: 37493579 BACKGROUND

• Kievit AJ, Buijs GS, Dobbe JGG, Ter Wee A, Kerkhoffs GMMJ, Streekstra GJ, Schafroth MU, Blankevoort L. Promising results of an non-invasive measurement of knee implant loosening using a loading device, CT-scans and 3D image analysis. Clin Biomech (Bristol). 2023 Apr;104:105930. doi: 10.1016/j.clinbiomech.2023.105930. Epub 2023 Mar 3.

  PMID: 36906985 BACKGROUND

Related Links

• Canadian Joint Replacement Registry

Study Officials

• Matthew Teeter, PhD

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

  STUDY DIRECTOR

• Brent Lanting, MD

  Lawson Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Lyndsay Somerville, PhD

  London Health Sciences Centre

  STUDY CHAIR

• Patrick J Mixa, MD

  Western University

  STUDY CHAIR

• James Howard, MD

  London Health Sciences Centre

  STUDY CHAIR

Central Study Contacts

Brent Lanting, MD

CONTACT

519-685-8500; brent.lanting@lhsc.on.ca

Farzan Mohammadreza, MSc

CONTACT

5197298079; farzan.mohammadreza@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One single visit: 1 loaded and 2 unloaded scans with weight-bearing CT. One loaded and 2 unloaded scans with conventional CT

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: April 4, 2025
• Study Start: June 20, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-08

Locations

CA (1)