- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07472088
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Patellofemoral joint (PFJ) pain is a common, often chronic, aching pain behind or around the kneecap, frequently called "runner's knee". It occurs when the kneecap does not glide smoothly over the thigh bone, often due to muscle weakness or overuse. It makes sitting for long periods, climbing stairs, or kneeling painful.
Symptomatic knee osteoarthritis (OA) is a common, long-term condition where the protective cartilage in the knee joint wears away, causing the bones to rub together, leading to daily pain and stiffness. In simple terms, it is a "wear-and-tear" disease of the entire joint that makes walking, climbing stairs, or bending the knee difficult.
The PFJ is where the patella (kneecap) meets the femoral trochlea (front part of the lower thigh bone) at the front of the knee. Patellar tracking refers to the movement of the patella that begins to engage in the distal femoral trochlear groove (smooth, U-shaped groove at the bottom of the thigh bone).
By doing this study, we hope to advance clinical knowledge of the PTJ features in a more natural position by using weight-bearing computed tomography (WBCT) images while the leg is straight and slightly bent. Determining links between specific knee symptoms and the PTJ structure on WBCT images could enable providers to effectively target the underlying causes and to develop targeted treatments.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patellofemoral joint (PFJ) is the articulation where the patella meets the femoral trochlea at the front of the knee. Patellar tracking refers to the movement of the patella that begins to engage in the distal femoral trochlear groove.
The proposed research will advance clinical knowledge of patellofemoral joint features in a more physiological position by using weight-bearing computed tomography (WBCT) images at 0° and 20° of knee flexion. Determining associations between specific knee symptoms and patellofemoral joint structural metrics on WBCT images could enable providers to effectively target the underlying causes and to develop targeted treatments.
PFJ features have become a significant area of interest, and numerous studies have been conducted to understand morphological characteristics, as it is the most common site associated with many knee symptoms and is a frequent location of early knee osteoarthritis (OA). There is growing evidence indicating that patellofemoral OA contributes to knee pain and functional limitations independent of tibiofemoral OA, and that the etiology and management may differ. A key factor in the risk profile for PFJ dysfunction may be malalignment of the patella with the femoral trochlea and subsequent abnormal tracking in the groove, leading to abnormal loading and wear of PFJ subchondral bone, microtearing of the lateral retinaculum, or irritation of the synovium, one of the most painful structures in the knee.
Quantifying patellofemoral alignment is an important aspect in assessing knee health, particularly in conditions that affect the PFJ, such as patellar instability, OA, or patellofemoral pain syndrome. There is no consensus on PFJ imaging position, knee flexion angle, joint position (e.g. stabilized or free), weight-bearing status, or beam angulation. However, the introduction of weight-bearing CT (WBCT) provides the ability to acquire 3D imaging of the PFJ under functionally loaded conditions. Using WBCT offers a unique advantage in this context because it allows for the evaluation of the knee in a loaded position, closely simulating the conditions under which the joint normally operates during activities like walking, running, and jumping, and under conditions in which the PFJ is symptomatic.
WBCT provides a three-dimensional view of the patellofemoral joint, allowing for the accurate measurement of various alignment parameters. These measurements may include the TT-TG, reTFR, patellar tilt angle, patellar height, and congruence angle. By analyzing these parameters, clinicians can gain insights into the alignment and positioning of the patella relative to the femur and the tibia.
Rationale:
WBCT can give us a better understanding of the patellofemoral joint in a loaded configuration in which the joint normally works during activities like walking, running, and jumping. This three-dimensional view will allow us to measure alignment parameters in a more functional position. This imaging technique is particularly valuable because it demonstrates the influence of factors such as muscle contractions or soft tissue conditions, the lack of which may distort results in non-weight-bearing assessments. Determining the extent to which these parameters are associated with knee symptoms will help to guide treatment decisions and improve clinical outcomes for patients with knee disorders.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jessica Lee, PhD
- Phone Number: 913-574-0961
- Email: jlee33@kumc.edu
Study Contact Backup
- Name: Yashaf Zaheer, MD
- Email: yzaheer@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
Contact:
- Jessica Lee, PhD
- Phone Number: 913-574-0961
- Email: jlee33@kumc.edu
-
Contact:
- Yashaf Zaheer, MD
- Email: yzaheer@kumc.edu
-
Principal Investigator:
- Neil A Segal, MD, MS
-
Sub-Investigator:
- Yashaf Zaheer, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18
- Knee pain, falling into either of the two groups, i.e., PFJ pain (pain only in the anterior region of the knee) or symptomatic knee OA (pain in any other area of the knee, including the anterior region)
Exclusion Criteria:
- Bilateral total knee arthroplasty
- Pregnant
- Unable to stand safely for 2 minutes with support
- Any condition that the investigator identifies as inappropriate for participation (e.g., unable to participant in consent process, unsafe to stand on WBCT platform, etc.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PFJ pain
Participants experiencing recurrent, atraumatic patella dislocation, knee pain isolated to the anterior region, or PFPS (pain around the patella, exacerbated by prolonged positioning or ascending/descending stairs)
|
Images of the knee will be acquired using a WBCT, which provides a three-dimensional view of the patellofemoral joint in a loaded configuration.
|
|
Symptomatic knee OA
Participants experiencing pain in any other area of the knee, including the anterior region in combination with other regions
|
Images of the knee will be acquired using a WBCT, which provides a three-dimensional view of the patellofemoral joint in a loaded configuration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TT-TG
Time Frame: From enrollment to end of study (1 day)
|
Tibial Tuberosity - Trochlear Grove (TT-TG) will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
|
From enrollment to end of study (1 day)
|
|
reTRF
Time Frame: From enrollment to end of study (1 day)
|
Relative external tibiofemoral rotation (reTFR) will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
|
From enrollment to end of study (1 day)
|
|
Congruence Angle
Time Frame: From enrollment to end of study (1 day)
|
Congruence angle will be measured on 3D WBCT knee images acquired at 20±5° of knee flexion.
|
From enrollment to end of study (1 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTA
Time Frame: From enrollment to end of study (1 day)
|
Patellar tilt angle (PTA) will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
|
From enrollment to end of study (1 day)
|
|
Bisect Offset
Time Frame: From enrollment to end of study (1 day)
|
Bisect offset will be measured on 3D WBCT knee images acquired at 0° of knee flexion.
|
From enrollment to end of study (1 day)
|
|
Patellar Height
Time Frame: From enrollment to end of study (1 day)
|
Patellar height will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
|
From enrollment to end of study (1 day)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patellar tilt
Time Frame: From enrollment to end of study (1 day)
|
The angle between the line connecting the most posterior points of femoral condyles and the patella axis through the medial and lateral borders will be measured on WBCT acquired at 0° of knee flexion.
|
From enrollment to end of study (1 day)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Neil A Segal, MD, MS, University of Kansas Medical Center
Publications and helpful links
General Publications
- Sieberer JM, Park N, Desroches S, Brennan K, Rancu A, McGinley B, Manafzadeh AR, Segal NA, Felson D, Tommasini SM, Wiznia DH, Fulkerson JP. Breaking down tibial tuberosity to trochlear groove distance into two components to enable patient-specific treatment strategies. J ISAKOS. 2026 Feb;16:101025. doi: 10.1016/j.jisako.2025.101025. Epub 2025 Oct 30.
- Park N, Sieberer JM, McGinley B, Manafzadeh AR, Lynch J, Segal NA, Lewis CE, Guermazi A, Roemer FW, Stefanik J, Felson DT, Fulkerson JP. Measures of Patellofemoral Morphology Predict the Risk of Local Cartilage Damage Progression: A Yale/MOST Collaborative Study. Am J Sports Med. 2025 Oct;53(12):2881-2888. doi: 10.1177/03635465251367716. Epub 2025 Sep 12.
- Park N, Sieberer J, Manafzadeh A, Hackbarth RM, Desroches S, Ghankot R, Lynch J, Segal NA, Stefanik J, Felson D, Fulkerson JP. Semiautomated Three-Dimensional Landmark Placement on Knee Models Is a Reliable Method to Describe Bone Shape and Alignment. Arthrosc Sports Med Rehabil. 2024 Nov 5;7(2):101036. doi: 10.1016/j.asmr.2024.101036. eCollection 2025 Apr.
- Yu KE, Beitler B, Cooperman DR, Frumberg D, Schneble C, McLaughlin W, Fulkerson JP. Three-Dimensional Reproductions for Surgical Decision-Making in the Treatment of Recurrent Patella Dislocation. Arthrosc Tech. 2023 May 1;12(6):e807-e811. doi: 10.1016/j.eats.2023.02.010. eCollection 2023 Jun.
- Sieberer JM, Park N, Manafzadeh AR, Desroches ST, Brennan K, McDonald C, Tommasini SM, Wiznia DH, Fulkerson JP. Visualization of Trochlear Dysplasia Using 3-Dimensional Curvature Analysis in Patients With Patellar Instability Facilitates Understanding and Improves the Reliability of the Entry Point to Trochlea Groove Angle. Arthrosc Sports Med Rehabil. 2024 Sep 26;7(1):101010. doi: 10.1016/j.asmr.2024.101010. eCollection 2025 Feb.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00162359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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