Quantifying Patellar Tendon Microstructure Using DTI

January 6, 2026 updated by: University of Wisconsin, Madison

Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Cases: Adults 18 years or older with a diagnosis of patellar tendinopathy, or with a history of anterior cruciate ligament (ACL) reconstruction using bone-patellar tendon-bone autograft.

Controls: Adults 18 years or older without a diagnosis of patellar tendinopathy or history of ACL reconstruction using bone-patellar tendon-bone autograft

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: MRI
MRI using DTI technology
Device: Ultrasound (US)
Standard US
Device: Neuromuscular electric stimulation (NMES)
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.
Device: MRI
MRI using DTI technology
Device: Ultrasound (US)
Standard US
Device: Neuromuscular electric stimulation (NMES)
Standard NMES
Healthy knees
Control group of participants with healthy knees
Device: MRI
MRI using DTI technology
Device: Ultrasound (US)
Standard US
Device: Neuromuscular electric stimulation (NMES)
Standard NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 2 weeks
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
Up to 2 weeks
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.
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

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

Investigators

  • Principal Investigator: Bryan Heiderscheit, PT, PhD, University of Wisconsin, Madison
  • Principal Investigator: Daniel Cobian, DPT, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Actual)

December 27, 2025

Study Completion (Actual)

December 27, 2025

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0057
  • A536130 (Other Identifier: UW Madison)
  • SMPH/ORTHO&REHAB/PHYS THER (Other Identifier: UW Madison)
  • 1K99AR085752-01 (U.S. NIH Grant/Contract)
  • Protocol Version 10/1/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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