Clinical trial NCT06381492: Quantifying Patellar Tendon Microstructure Using DTI
Official title: Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patellar Tendinopathy
Anterior Cruciate Ligament Reconstruction
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare scalar parameters of known patellar tendon pathology to the contralateral tendon
timeFrame: Up to 2 weeks
measure: Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon
timeFrame: Up to 2 weeks
measure: Rank patellar tendon loads during exercise
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bryan Heiderscheit, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Daniel Cobian, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: