Quantifying Patellar Tendon Microstructure Using DTI

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381492
• Other study ID #: 2024-0057
• Secondary ID: A536130SMPH/ORTH
• Status: Recruiting
• Start date: May 21, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Maria Flory
• Phone: 608-262-8652
• Email: flory[@]ortho.wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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 bilateral patellar tendinopathy, history of contralateral BPTB autograft harvest, or ACLR using any other graft type

• Participants with contraindications to MRI

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Patellar Tendinopathy
• Tendinopathy

Intervention

Device:
• MRI
MRI using DTI technology
• Ultrasound (US)
Standard US

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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