Quantifying Patellar Tendon Microstructure Using DTI

Recruiting

• Conditions: Anterior Cruciate Ligament Reconstruction; Patellar Tendinopathy

• Registration Number: NCT06381492
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Study Start: 2024-05-21
• Status Verified: 2024-12
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare scalar parameters of known patellar tendon pathology to the contralateral tendon	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	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	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.

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States