Quantifying Patellar Tendon Microstructure Using DTI

NCT06381492 | Completed DMC FDA Device

• 5 other identifiers: 2024-00571K99AR085752-01A536130SMPH/ORTHO&REHAB/PHYS THERProtocol Version 10/1/2025
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Patellar Tendinopathy; Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (3)

• Compare scalar parameters of known patellar tendon pathology to the contralateral tendon

  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

  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

  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

Study Arms (3)

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

Healthy knees

Control group of participants with healthy knees

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

Interventions

MRI DEVICE

MRI using DTI technology

Bone-patellar tendon-bone (BPTB); Healthy knees; Patellar tendinopathy group

Ultrasound (US) DEVICE

Standard US

Bone-patellar tendon-bone (BPTB); Healthy knees; Patellar tendinopathy group

Neuromuscular electric stimulation (NMES) DEVICE

Standard NMES

Bone-patellar tendon-bone (BPTB); Healthy knees; Patellar tendinopathy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bryan Heiderscheit, PT, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Daniel Cobian, DPT, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 21, 2024
• Primary Completion: December 27, 2025
• Study Completion: December 27, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)