Periprosthetic Fracture Around Prosthetic Joint ImplantNCT06909916
Weight-Bearing CT and Conventional Periprosthetic Distal Knee Fractures
A study testing Periprosthetic Fracture Knee Repaired CT Scans in people with Periprosthetic Fracture Around Prosthetic Joint Implant, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Periprosthetic Fracture Around Prosthetic Joint Implant
- What is being tested?
- Periprosthetic Fracture Knee Repaired CT Scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Hospital - London Health Sciences Centre
London, Ontario, N6A 5A5
Brent Lanting, MD, 519-685-8500 ext. 33335, brent.lanting@lhsc.on.ca
Farzan Mohammadreza Mohammadreza, MSc, 519-729-8079, farzan.mohammadreza@lhsc.on.ca
About this study
Official title: Assessment of Bone Displacement Under Loading Following Distal Femur Periprosthetic Fracture Repair With Weight-Bearing CT and Conventional CT
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.
Read the 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. However, the availability of weight- bearing CT will always be lesser than conventional clinical CT scanners, even as more and more high volume orthopaedic centres are acquiring weight-bearing CT scanners. While some groups have implemented specialized loading devices to perform such scans with conventional CT,17 a more generalizable approach of simple internal-external leg rotations held in place with tape would ultimately offer the greatest potential uptake across centres.
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 CT and conventional CT scanners. 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. Consideration for the ability to perform similar measurements with conventional CT in place of weight-bearing CT will 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 both weight-bearing CT and conventional CT.
- Being tested
- Periprosthetic Fracture Knee Repaired CT Scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periprosthetic Fracture Knee Repaired CT ScansOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Periprosthetic Fracture Knee Repaired CT Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start20 Jun 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Fracture Around Prosthetic Joint ImplantStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One single visit: 1 loaded and 2 unloaded scans with weight-bearing CT. One loaded and 2 unloaded scans with conventional CT
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Teeter, PhD, Study director, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sBrent Lanting, MD, Principal investigator, Lawson Health Sciences CentreLyndsay Somerville, PhD, Study chair, London Health Sciences CentrePatrick J Mixa, MD, Study chair, Western UniversityJames Howard, MD, Study chair, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909916
- Sponsor's protocol ID
- 14154
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33390337Sinclair 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.
PubMed 34660865Crellin 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
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.
PubMed 34531088Klug 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.
PubMed 32671435Aspinall 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
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.
PubMed 16195075Rohrl 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.
PubMed 33143497Angelomenos 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.
PubMed 35478261Broden 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.
PubMed 33821746Stigbrand 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.
PubMed 32452289Eriksson 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.
PubMed 31042065Sandberg 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.
PubMed 37493579Kievit 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.
PubMed 36906985
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Displacement Under Loading Following Distal Femur Periprosthetic Fracture Repair With Weight-Bearing CT and Conventional CT
- ClinicalTrials.gov ID
- NCT06909916
- Acronym / sponsor ID
- 14154
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. However, the availability of weight- bearing CT will always be lesser than conventional clinical CT scanners, even as more and more high volume orthopaedic centres are acquiring weight-bearing CT scanners. While some groups have implemented specialized loading devices to perform such scans with conventional CT,17 a more generalizable approach of simple internal-external leg rotations held in place with tape would ultimately offer the greatest potential uptake across centres.
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 CT and conventional CT scanners. 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. Consideration for the ability to perform similar measurements with conventional CT in place of weight-bearing CT will 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 both weight-bearing CT and conventional CT.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One single visit: 1 loaded and 2 unloaded scans with weight-bearing CT. One loaded and 2 unloaded scans with conventional CT
| Arm | Type | Receives |
|---|---|---|
| Periprosthetic Fracture Knee Repaired | Experimental | Other: Periprosthetic Fracture Knee Repaired CT ScansThe one and only group will be participants that have undergone revision surgery for at least 1> year prior for their periprosthetic distal knee fracture. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periprosthetic Fracture Knee Repaired CT ScansThe 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. | Other | Periprosthetic Fracture Knee Repaired |
Primary outcome
Maximum Total Point Motion of Fracture Segments from Conventional CT scans
Time frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
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.
Maximum Total Point Motion of Fracture Segments from Conventional CT scans
Time frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire
Time frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
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.
The Knee Society Score (KSS) Questionnaire
Time frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
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.
UCLA Activity Score Guideline Questionnaire
Time frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 33390337Steele 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.
- Background: PubMed 34660865Sinclair 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.
- BackgroundCrellin 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: PubMed 34531088Wittauer 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.
- Background: PubMed 32671435Klug 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.
- BackgroundAspinall 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: PubMed 16195075Valstar 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.
- Background: PubMed 33143497Rohrl 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.
- Background: PubMed 35478261Angelomenos 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.
- Background: PubMed 33821746Broden 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.
- Background: PubMed 32452289Stigbrand 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.
- Background: PubMed 31042065Eriksson 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.
- Canadian Joint Replacement RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Teeter, PhD study director
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Brent Lanting, MD principal investigator
Lawson Health Sciences Centre
Lyndsay Somerville, PhD study chair
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periprosthetic Fracture Knee Repaired CT Scans in people with Periprosthetic Fracture Around Prosthetic Joint Implant, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brent Lanting, MD (519-685-8500 ext. 33335, brent.lanting@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Total Point Motion of Fracture Segments from Conventional CT scans (time frame: 1 visit is only required for which the outcome measure will then be assessed. Through study completion, approximately of 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06909916, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.