Weight-Bearing CT Periprosthetic Distal Knee Fractures

July 24, 2024 updated by: Lawson Health Research Institute

Assessment of Bone Displacement Under Loading Following Periprosthetic Fracture Repair With Weight-Bearing CT

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty is the most cost-effective and successful treatment for knee joints with end-stage osteoarthritis, with more than 58,000 TKA surgeries in Canada in 2021-2022.1 The prevalence of TKA surgeries is increasing per year and is projected to rise due to an ageing population and obesity problems.1 In addition to the primary surgery, more than 4,000 Canadians require revision TKA surgery per year; the TKA revision burden is estimated to reach $13 billion by 2030 as a consequence of a substantial increase of 149% in primary surgeries by 2030 in the United States.1-3 Revision surgery is more invasive than primary surgery and poses the risk of increasing patient mortality rates, especially for older adults.3 Thus, it is imperative for surgeons to make an appropriate radiographic diagnosis of implant fixation and/or fracture healing, but many cases remain challenging to diagnose.4

In the orthopaedic literature, there is no consensus on a reliable definition criterion for long-bone non-unions, making the standardization of diagnoses difficult; the lack of a trustworthy assessment for component fixation and fracture healing can lead to patients receiving sub-optimal care.5 This can also limit the collection of evidence supporting the use of specific implant components, surgical techniques, and post-operative activity guidelines. Moreover, comparing healing results of different clinical studies for long-bone non-unions can become problematic due to different criteria being used.5 Radiographic features associated with loosening such as radiolucencies are often only appreciable for the cement-bone interface, rather than the cement-implant interface which is the most common site of failure causing loosening.4 Failure to properly diagnose fracture non-union leaves patients in pain with substantial morbidity, while unnecessary surgery risks significant complication. Given the increasing rates of TKA and associated predictions of increasing revision burden,6 along with ongoing debates over the superiority of certain implants or surgical techniques, there is an unmet need for better fixation and bone healing assessment.

Historically, radiostereometric analysis (RSA) has been the gold standard for measuring implant fixation.7 However, it remains a niche tool limited to clinical research because of its requirement for implanted marker beads and specialized equipment being accessible for a handful of labs in North America.7-8 Recently, multiple groups have developed approaches to perform RSA-like measurements using clinical CT scans for shoulder, hip, and knee replacements.9 The accuracy and precision of the "CT-RSA" methods are on par with conventional RSA and acceptable for clinical studies.10-15 It is predicted that there will be a greater uptake of CT-RSA than conventional RSA, but the technology is still in its infancy.9 The application of CT-RSA will undoubtedly be more inclusive as examinations can now be performed on patients who did not have marker beads implanted at the time of their original surgery, and CAD models of implants are not needed.16 Using a weight-bearing CT scanner is the most similar implementation of CT-RSA to conventional RSA, as exams can be acquired in unloaded and loaded positions.

Additionally, in the field of microbiome research, the gut microbiome is being investigated for its potential impacts on bone health and recovery. There are currently a few studies that have linked the intestinal microbiome having a beneficiary effect to fracture healing with a new concept referred to as the gut-bone axis.17 Moreover, the gut microbiome of patients with poor bone quality has previously been found to be altered.18 We will use stool samples to assess gut microbiome composition to see if patients with markers for poor bone quality could have increased migration.

The results of this proposed study will demonstrate the ability to precisely measure displacements between bone segments under loading following periprosthetic fracture repair with weight-bearing. These will be the first-ever measurements of distal femur periprosthetic fracture healing with weight-bearing CT-RSA. Demonstration of this will enable us to pursue future studies that are prospective in nature and may evaluate topics such as time to weight-bearing activities, different types of surgical reconstructions, and relationship between healing and bone quality/bone health. Other centres with access to weight-bearing CT will also benefit from this work. Usage of the weight-bearing CT may improve the generalizability of this approach and support it as a clinical diagnostic tool. For example, surgeons may better understand bone fragment motion over time and recommend appropriate postoperative activities for patients' weight-bearing tolerance. Therefore, the proposed study design will evaluate the ability to perform inducible displacement measurements following the surgical repair of distal femur periprosthetic fractures using weight-bearing CT.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Periprosthetic Fracture Knee Repaired
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-Bearing CT Scans
Time Frame: Scans obtained: <1-week post-operation, 6-weeks, and 1-year
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
Time Frame: <1-week post-operation, 6 weeks, and 1-year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool sample
Time Frame: 6-week timepoint post-operation
Stool sample collected from participant and analyzed and compared to CT scans for bone healing assessments.
6-week timepoint post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Brent Lanting, MD, London Health Sciences Centre
  • Study Director: Matthew Teeter, PhD, Lawson Health Research Institute
  • Study Chair: Farzan Mohammadreza, MSc, Lawson Health Research Institute
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14177 (company internal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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