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临床试验/NCT06381492
NCT06381492已完成不适用

Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Compare scalar parameters of known patellar tendon pathology to the contralateral tendon

研究概览

简要总结

The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is:

Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon.

Participants will:

  • undergo MRI and ultrasound imaging
  • perform knee function test
  • complete questionnaires

详细描述

Patellar tendon injuries are commonly accompanied by macrostructural alterations captured on common imaging modalities, and the extent of these alterations correlate to knee joint function. Evidence for using tendon macrostructure for diagnosis and prognosis of tendon injuries is not as clear, suggesting that these imaging modalities are not providing a complete picture of the alterations. Diffusion tensor imaging (DTI) tractography can quantify tendon microstructures that underlie the alterations in pathological tendons and shows promising results in healthy tendons. This study is the first step in evaluating whether tendon microstructure captured using DTI technology can be applied as a biomarker to optimize treatment for patellar tendon injuries.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Have patellar tendon injury as confirmed through subjective report, clinical examination, and ultrasound by an experienced physical therapist
  • Patellar tendinopathy group must present with current symptoms of patellar tendinopathy
  • Control group must have no history of patellar tendon injury

排除标准

  • Participants with a history of invasive procedures other than bone-patellar tendon-bone (BPTB) autograft harvest to the patellar tendon or extensor mechanism
  • Participants with history of contralateral BPTB autograft harvest, or ACLR using any other graft type
  • Participants with contraindications to MRI
  • Participants with contraindications to NMES

研究组 & 干预措施

Bone-patellar tendon-bone (BPTB)

This group will have patellar injury confirmed through self-reported surgical history and evidence of ipsilateral BPTB graft harvest on ultrasound.

干预措施: MRI (Device)

Bone-patellar tendon-bone (BPTB)

This group will have patellar injury confirmed through self-reported surgical history and evidence of ipsilateral BPTB graft harvest on ultrasound.

干预措施: Ultrasound (US) (Device)

Bone-patellar tendon-bone (BPTB)

This group will have patellar injury confirmed through self-reported surgical history and evidence of ipsilateral BPTB graft harvest on ultrasound.

干预措施: Neuromuscular electric stimulation (NMES) (Device)

Patellar tendinopathy group

This group will have patellar tendinopathy confirmed based on International Scientific Tendinopathy Symposium Consensus on Clinical Terminology (ICON) statement, which defines patellar tendinopathy as "persistent patellar tendon pain and loss of function related to mechanical loading." Ultrasound diagnosis must confirm alteration of tendon macrostructure.

干预措施: MRI (Device)

Patellar tendinopathy group

This group will have patellar tendinopathy confirmed based on International Scientific Tendinopathy Symposium Consensus on Clinical Terminology (ICON) statement, which defines patellar tendinopathy as "persistent patellar tendon pain and loss of function related to mechanical loading." Ultrasound diagnosis must confirm alteration of tendon macrostructure.

干预措施: Ultrasound (US) (Device)

Patellar tendinopathy group

This group will have patellar tendinopathy confirmed based on International Scientific Tendinopathy Symposium Consensus on Clinical Terminology (ICON) statement, which defines patellar tendinopathy as "persistent patellar tendon pain and loss of function related to mechanical loading." Ultrasound diagnosis must confirm alteration of tendon macrostructure.

干预措施: Neuromuscular electric stimulation (NMES) (Device)

Healthy knees

Control group of participants with healthy knees

干预措施: MRI (Device)

Healthy knees

Control group of participants with healthy knees

干预措施: Ultrasound (US) (Device)

Healthy knees

Control group of participants with healthy knees

干预措施: Neuromuscular electric stimulation (NMES) (Device)

结局指标

主要结局

Compare scalar parameters of known patellar tendon pathology to the contralateral tendon

时间窗: Up to 2 weeks

DTI parameters will be obtained by built-in diffusion-weighted sequences on the GE MRI machine. Regions of interest will be selected using clinical scans, and region specific DTI parameters will be compared between regions and over the repeat test sessions

Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon

时间窗: Up to 2 weeks

DTI parameters will be obtained by built-in diffusion-weighted sequences on the GE MRI machine. Regions of interest will be selected using clinical scans, and region specific DTI parameters will be compared between regions and over the repeat test sessions

Rank patellar tendon loads during exercise

时间窗: Up to 2 weeks

Patellar tendon loads will be obtained by tensiometer measurements during common exercises for patellar tendon rehabilitation while subject wears NMES sensors. Patellar tendon loads will be compared between regions and over the repeat test sessions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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