Quantifying Patellar Tendon Microstructure Using DTI

University of Wisconsin (UW)

Status: Completed

Conditions: Anterior Cruciate Ligament Reconstruction; Patellar Tendinopathy

Treatments: Device: Neuromuscular electric stimulation (NMES); Device: Ultrasound (US); Device: MRI

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06381492

Protocol Version 10/1/2025 (Other Identifier)

1K99AR085752-01 (U.S. NIH Grant/Contract)

2024-0057

A536130 (Other Identifier)

SMPH/ORTHO&REHAB/PHYS THER (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

62 participants in 3 patient groups

Bone-patellar tendon-bone (BPTB)

Description:

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

Treatment:

Device: MRI

Device: Neuromuscular electric stimulation (NMES)

Device: Ultrasound (US)

Patellar tendinopathy group

Description:

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.

Treatment:

Device: MRI

Device: Neuromuscular electric stimulation (NMES)

Device: Ultrasound (US)

Healthy knees

Description:

Control group of participants with healthy knees

Treatment:

Device: MRI

Device: Neuromuscular electric stimulation (NMES)

Device: Ultrasound (US)