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Quantifying Patellar Tendon Microstructure Using DTI

Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06381492
Enrollment
62
Registered
2024-04-24
Start date
2024-05-21
Completion date
2025-12-27
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellar Tendinopathy, Anterior Cruciate Ligament Reconstruction

Brief summary

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

Detailed description

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.

Interventions

Standard US

DEVICENeuromuscular electric stimulation (NMES)

Standard NMES

DEVICEMRI

MRI using DTI technology

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Compare scalar parameters of known patellar tendon pathology to the contralateral tendonUp to 2 weeksDTI 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 tendonUp to 2 weeksDTI 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 exerciseUp to 2 weeksPatellar 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026