Patellar TendinopathyNCT06381492
Quantifying Patellar Tendon Microstructure Using DTI
An observational study of Patellar Tendinopathy and Anterior Cruciate Ligament Reconstruction, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patellar Tendinopathy, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- MRI, Ultrasound (US) and Neuromuscular electric stimulation (NMES)
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 27 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
Official title: 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
Read the 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.
- Being tested
- MRI, Ultrasound (US), Neuromuscular electric stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI using DTI technology
Ultrasound (US)Device
Standard US
Neuromuscular electric stimulation (NMES)Device
Standard NMES
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MRI; Device: Ultrasound (US); Device: Neuromuscular electric stimulation (NMES) | |
| Healthy knees | Control group of participants with healthy knees Receives: Device: MRI; Device: Ultrasound (US); Device: Neuromuscular electric stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start21 May 2024
- Primary completion27 Dec 2025
- Study completion27 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Bryan Heiderscheit, PT, PhD, Principal investigator, University of Wisconsin, MadisonDaniel Cobian, DPT, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381492
- Sponsor's protocol ID
- 2024-0057
- Other IDs
- 1K99AR085752-01, A536130, SMPH/ORTHO&REHAB/PHYS THER, Protocol Version 10/1/2025
- Status last verified
- Jan 2026
- First submitted
- 19 Apr 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Patellar Tendon Microstructure Using Diffusion Tensor Imaging
- ClinicalTrials.gov ID
- NCT06381492
- Acronym / sponsor ID
- 2024-0057
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 27 Dec 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bone-patellar tendon-bone (BPTB) | – | Device: MRI, Device: Ultrasound (US), Device: Neuromuscular electric stimulation (NMES)This group will have patellar injury confirmed through self-reported surgical history and evidence of ipsilateral BPTB graft harvest on ultrasound. |
| Patellar tendinopathy group | – | Device: MRI, Device: Ultrasound (US), Device: Neuromuscular electric stimulation (NMES)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. |
| Healthy knees | – | Device: MRI, Device: Ultrasound (US), Device: Neuromuscular electric stimulation (NMES)Control group of participants with healthy knees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI using DTI technology | Device | Bone-patellar tendon-bone (BPTB), Healthy knees, Patellar tendinopathy group |
| Ultrasound (US)Standard US | Device | Bone-patellar tendon-bone (BPTB), Healthy knees, Patellar tendinopathy group |
| Neuromuscular electric stimulation (NMES)Standard NMES | Device | Bone-patellar tendon-bone (BPTB), Healthy knees, Patellar tendinopathy group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Patellar Tendinopathy
Enrolling by invitation
Photobiomodultion in Anterior Knee Pain
Anterior Knee Pain, Photobiomodulation (PBM)
Recruiting
Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk
Patellar Tendinitis, Jumper's Knee
Active, not recruiting
Chronic Patellar Tendinopathy (PT)is Prevalent in Participants of Several Sports.A Three-arm, Single-blind Randomized Controlled Trial Will be Conducted. We Want to Compare the Clinical Effectiveness of ESWT Alone, ESWT Combined With Hyaluronic Acid, and ESWT Combined With PRP in Athletes With PT
Chronic Patellar Tendinopathy
Enrolling by invitation
Effects of Resistance Training on Patellar Tendon Properties in People With Patellar Tendinoapthy
Patellar Tendinopathy
Active, not recruiting
Unlocking the Hidden Effects of Shockwave: Longitudinal Changes in Sensorimotor Function and Kinesiophobia in Adolescents With Patellar Tendinopathy
Patellar Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Heiderscheit, PT, PhD principal investigator
University of Wisconsin, Madison
Daniel Cobian, DPT, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Tendinopathy and Anterior Cruciate Ligament Reconstruction, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare scalar parameters of known patellar tendon pathology to the contralateral tendon (time frame: Up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.