Weight-Bearing CT Periprosthetic Distal Knee Fractures

NCT06525610 | Not Yet Recruiting

• 1 other identifier: 14177
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total knee arthroplasty (TKA), a knee implant surgery, is a treatment for end-stage knee osteoarthritis. In some cases, patients suffer an associated periprosthetic fracture, a broken bone that occurs around the implant of a TKA, they may not receive excellent care due to a lack of a trustworthy assessments for fracture healing in the research world. The prevalence of TKA surgeries is increasing annually and is expected to increase 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 important to set a standard for fracture stabilization and bone healing assessments to lessen revision burdens and improve patient outcomes. CT imaging is the main clinical tool to evaluate implant stabilization in TKA, which can effectively visualize areas of incomplete bone ingrowth, bone growing into the implant, that may be hidden from overlapping bone and muscle tissue on plain x-rays. The purpose of this prospective study is to examine the efficacy of weight-bearing CT as a diagnostic tool for 21 participants who experienced a distal femur periprosthetic fracture and have underwent revision surgery using a fracture fixation plate and screws, internal splints that hold the bone pieces together. Participants will be scanned under loaded (applying weight on limb) and unloaded conditions. Radiographic outcomes, x-ray imaging from the weight-bearing CT, will be evaluated, including any movement of the bone segments and how they would relate to participants' reports of pain.

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant Knee

Outcome Measures

Primary Outcomes (2)

• Weight-Bearing CT Scans

  Weight-bearing CT scans of the periprosthetic distal knee fracture that has undergone revision surgery

  Scans obtained: <1-week post-operation, 6-weeks, and 1-year

• Pain and Function Questionnaires

  Pain and function questionnaires that assess the pain and ability-to-function of the knee. These are participant-reported outcomes and they will be compared to the CT scans

  <1-week post-operation, 6 weeks, and 1-year

Secondary Outcomes (1)

• Stool sample

  6-week timepoint post-operation

Study Arms (1)

Periprosthetic Fracture Knee Repaired

EXPERIMENTAL

The one and only group will be participants that have recently undergone revision surgery for their periprosthetic distal knee fracture.

Other: Periprosthetic Fracture Knee Repaired CT Scans

Interventions

Periprosthetic Fracture Knee Repaired CT Scans OTHER

We will be assessing the use of weight-bearing CT, specifically its imaging, with RSA-like software, for analyzing fracture healing over time 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:

• Recently underwent revision surgery for repair of a distal femur fracture surgery for total knee arthroplasty femoral component using a fracture fixation plate. Due to the study requiring the potential participant to be scanned \<1-week post-operation, the duration of "recently" will be defined as \<1 week post-operation.
• 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:

• Prior revision surgery on the targeted knee
• Does not understand English
• Undergoing and/or have 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

Related Publications (17)

• 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

• Engseth LHW, Schulz A, Pripp AH, Rohrl SMH, Ohrn FD. CT-based migration analysis is more precise than radiostereometric analysis for tibial implants: a phantom study on a porcine cadaver. Acta Orthop. 2023 Apr 27;94:207-214. doi: 10.2340/17453674.2023.12306.

  PMID: 37114404 BACKGROUND

• Broden C, Sandberg O, Skoldenberg O, Stigbrand H, Hanni M, Giles JW, Emery R, Lazarinis S, Nystrom A, Olivecrona H. Low-dose CT-based implant motion analysis is a precise tool for early migration measurements of hip cups: a clinical study of 24 patients. Acta Orthop. 2020 Jun;91(3):260-265. doi: 10.1080/17453674.2020.1725345. Epub 2020 Feb 14.

  PMID: 32056507 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

• Karačić A, Novak J, Ivković. Probiotics in bone fracture treatment? A narrative literature review. Microbiota and Host, 2023;1(1):e230003. doi: 10.1530/MAH-23-0003

  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

Related Links

• Canadian Jount 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

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Farzan Mohammadreza, MSc

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

  STUDY CHAIR

• 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

519-729-8079; 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: \<1 week post-operation: 1 unloaded scan with the weight-bearing CT will be conducted 6 weeks: 1 unloaded and loaded scan with the weight-bearing CT. Subjects will get a one-time pre-paid, pre-addressed envelope with a DNA-free bag. They will place a stool sample in the bag collected on dry toilet paper and then send it to Dr. Jeremy Burton's lab at St. Joseph's Hospital for processing and analysis. Data will be processed at St. Joseph's Hospital site. Once DNA is extracted, the specimens will be destroyed and disposed. No further stool samples will be collected on follow-up visits. 1 year: 1 unloaded scan and 2 loaded scans with the weight-bearing CT will be conducted. A second loaded exam is performed at the 1-year visit as a "double exposure" exam to measure for clinically relevant measurement errors

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07