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Completed

NCT Number: NCT06381492

Quantifying Patellar Tendon Microstructure Using DTI

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

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Key information

Conditions

Patellar Tendinopathy Anterior Cruciate Ligament Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MRI

Device

MRI using DTI technology

Ultrasound (US)

Device

Standard US

Neuromuscular electric stimulation (NMES)

Device

Standard NMES

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

  3. Rank patellar tendon loads during exercise

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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