Knee OsteoarthritisNCT07472088
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
An observational study of Knee Osteoarthritis and Patellofemoral Pain (PFPS), run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Patellofemoral Pain (PFPS)
- What is being tested?
- WBCT
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Voluntary participants who consented to be contacted for research
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yashaf Zaheer, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jessica Lee, PhD, 913-574-0958, jlee33@kumc.edu
Yashaf Zaheer, MD, yzaheer@kumc.edu
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Patellofemoral Pain (PFPS)
- Being tested
- WBCT
- Keywords
- patellofemoral joint, knee osteoarthritis, weight-bearing CT (WBCT)
- Medical subject headings
- Osteoarthritis, Knee, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBCTRadiation
Images of the knee will be acquired using a WBCT, which provides a three-dimensional view of the patellofemoral joint in a loaded configuration.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Radiation: WBCT | |
| Symptomatic knee OA | Participants experiencing pain in any other area of the knee, including the anterior region in combination with other regions Receives: Radiation: WBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
TT-TG
Tibial Tuberosity - Trochlear Grove (TT-TG) will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
Measured: From enrollment to end of study (1 day)
reTRF
Relative external tibiofemoral rotation (reTFR) will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
Measured: From enrollment to end of study (1 day)
Congruence Angle
Congruence angle will be measured on 3D WBCT knee images acquired at 20±5° of knee flexion.
Measured: From enrollment to end of study (1 day)
Secondary outcomes (3)
PTA
Patellar tilt angle (PTA) will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
Measured: From enrollment to end of study (1 day)
Bisect Offset
Bisect offset will be measured on 3D WBCT knee images acquired at 0° of knee flexion.
Measured: From enrollment to end of study (1 day)
Patellar Height
Patellar height will be measured on 3D WBCT knee images acquired at 0° and 20±5° of knee flexion.
Measured: From enrollment to end of study (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start29 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Segal, MD, MS, University of Kansas Medical Center
- Investigators
- Neil A Segal, MD, MS, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472088
- Sponsor's protocol ID
- STUDY00162359
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 41173215Park 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.
PubMed 40938089Park 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.
PubMed 40297085Yu 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.
PubMed 37424639Sieberer 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.
PubMed 40041820
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
- ClinicalTrials.gov ID
- NCT07472088
- Acronym / sponsor ID
- STUDY00162359
- Conditions
- Knee Osteoarthritis, Patellofemoral Pain (PFPS)
- Keywords
- patellofemoral joint, knee osteoarthritis, weight-bearing CT (WBCT)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFJ pain | – | Radiation: WBCTParticipants 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) |
| Symptomatic knee OA | – | Radiation: WBCTParticipants experiencing pain in any other area of the knee, including the anterior region in combination with other regions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Voluntary participants who consented to be contacted for research
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.)
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 |
|---|---|---|
| WBCTImages of the knee will be acquired using a WBCT, which provides a three-dimensional view of the patellofemoral joint in a loaded configuration. | Radiation | PFJ pain, Symptomatic knee OA |
Primary outcome
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.
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.
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.
3 secondary outcomes
PTA
Time frame: From enrollment to end of study (1 day)
Bisect Offset
Time frame: From enrollment to end of study (1 day)
Patellar Height
Time frame: From enrollment to end of study (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 41173215Sieberer 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.
- Background: PubMed 40938089Park 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.
- Background: PubMed 40297085Park 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.
- Background: PubMed 37424639Yu 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.
- Background: PubMed 40041820Sieberer 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.
- Individual participant dataSharing planned: No
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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.
Yashaf Zaheer, MD contact
Neil A Segal, MD, MS principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Patellofemoral Pain (PFPS), run by University of Kansas Medical Center at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Lee, PhD (913-574-0958, jlee33@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TT-TG (time frame: From enrollment to end of study (1 day)). The study lists 3 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 NCT07472088, which also lists 5 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 8 Oct 2026.