Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Compare scalar parameters of known patellar tendon pathology to the contralateral tendon
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: MRI (Device)
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.
Intervention: Ultrasound (US) (Device)
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.
Intervention: Neuromuscular electric stimulation (NMES) (Device)
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.
Intervention: MRI (Device)
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.
Intervention: Ultrasound (US) (Device)
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.
Intervention: Neuromuscular electric stimulation (NMES) (Device)
Healthy knees
Control group of participants with healthy knees
Intervention: MRI (Device)
Healthy knees
Control group of participants with healthy knees
Intervention: Ultrasound (US) (Device)
Healthy knees
Control group of participants with healthy knees
Intervention: Neuromuscular electric stimulation (NMES) (Device)
Outcomes
Primary Outcomes
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
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
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.
Secondary Outcomes
No secondary outcomes reported