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Идёт набор NCT07472088

Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms

Наблюдательное Knee Osteoarthritis Patellofemoral Pain (PFPS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: WBCT.
Кому может быть актуально
Состояния в реестре: Knee Osteoarthritis, Patellofemoral Pain (PFPS). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Лучевая терапия WBCT
    Images of the knee will be acquired using a WBCT, which provides a three-dimensional view of the patellofemoral joint in a loaded configuration.

Первичные конечные точки

  • TT-TG [Срок оценки: From enrollment to end of study (1 day)]
  • reTRF [Срок оценки: From enrollment to end of study (1 day)]
  • Congruence Angle [Срок оценки: From enrollment to end of study (1 day)]
Вторичные конечные точки (3)
  • PTA [Срок оценки: From enrollment to end of study (1 day)]
  • Bisect Offset [Срок оценки: From enrollment to end of study (1 day)]
  • Patellar Height [Срок оценки: From enrollment to end of study (1 day)]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • University of Kansas Medical Center — Kansas City

Публикации

  • 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. PMID 41173215
  • 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. PMID 40938089
  • 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. PMID 40297085
  • 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. PMID 37424639
  • 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. PMID 40041820

Идентификаторы

NCT: NCT07472088 · STUDY00162359

Первоисточники (государственные реестры)

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