Quantifying Patellar Tendon Microstructure Using DTI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-21

Study Completion Date

2025-12-27

Brief Summary

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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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Detailed Description

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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.

Conditions

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Patellar Tendinopathy Anterior Cruciate Ligament Reconstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type DEVICE

MRI using DTI technology

Ultrasound (US)

Intervention Type DEVICE

Standard US

Neuromuscular electric stimulation (NMES)

Intervention Type DEVICE

Standard NMES

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.

MRI

Intervention Type DEVICE

MRI using DTI technology

Ultrasound (US)

Intervention Type DEVICE

Standard US

Neuromuscular electric stimulation (NMES)

Intervention Type DEVICE

Standard NMES

Healthy knees

Control group of participants with healthy knees

MRI

Intervention Type DEVICE

MRI using DTI technology

Ultrasound (US)

Intervention Type DEVICE

Standard US

Neuromuscular electric stimulation (NMES)

Intervention Type DEVICE

Standard NMES

Interventions

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MRI

MRI using DTI technology

Intervention Type DEVICE

Ultrasound (US)

Standard US

Intervention Type DEVICE

Neuromuscular electric stimulation (NMES)

Standard NMES

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes