Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076073
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Nemet, MD, Meir Medical Center

Brief Summary:
The aim of the current study is to evaluate the Patellar tendon and Achilles tendon structures among children, adolescents and adults with different weight status. That in order to improve our understanding on the impact of acute and overused loads on tendon structure; and, in developing strategies to reduce tendon's injuries following physical exercises.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Obesity Tendon Thickening Other: Impact of physical activity on tendons Not Applicable

Detailed Description:

Studies showed that the probability of tendon abnormalities is higher in obese subjects compared to normal weight peer. Adiposity has been recognized as a risk factor for alterations in load- bearing tendons; and, different impact of loading exercises on tendon structure has been reported for obese individuals compared to normal weight individuals. The aim of the current study is to evaluate the Patellar tendon and Achilles tendon structures among children, adolescents and adults with different weight status. That in order to improve our understanding on the impact of acute and overused loads on tendon structure; and, in developing strategies to reduce tendon's injuries following physical exercises.

Tendon structure would be evaluated with UTC-imaging ultrasound device. UTC imaging allows for three-dimensional imaging of the tendon, semi- quantification of structure, and calculation of tendon dimensions. The resultant UTC analysis quantify the tendon into four echo types (I-IV) based on the stability of pixel brightness over contiguous images allowing inferences to be made on the alignment of tendon bundles. Briefly, echo types I and II correspond with relatively high stability in gray-scale pixel brightness over contiguous images due to one resulting US signal transmission. These echo types correspond with aligned fibrillar structure (AFS) within the tendon. Echo types III and IV are generated by multiple signal transmission that interfere as a consequence of multiple interfaces. These echo types represent a disorganized amorphous fibrillar structure that has non parallel fiber arrangement. For this study, the relative percentage and (muscle cross section area (mCSA) of these parameters were the main outcomes investigated. A linear-array US transducer (SmartProbe, A 10- megahertz (MHz) linear-array transducer, USA) mounted within a customized tracking device with motor drive and built-in acoustic stand off pad (UTC Tracker, UTC Imaging, Netherlands) was placed on the skin, perpendicular to the long axis of the tendon (Achilles or patellar), ensuring that the calcaneus or inferior pole of the patella was visible. Coupling gel was applied between the transducer, standoff pad, and skin to ensure maximum contact. Once a clear transverse image of the tendon and bony landmark was established, the motor drive automatically moved the transducer over the length of the tendon capturing a transverse grayscale US image every 0.2 mm over a distance of 12 cm. By compounding these images, a gray-scale US image data block is rendered that allows the tendon to be viewed in three planes: transverse, sagittal, and coronal (UTC2010, UTC Imaging). From this data block, each tendon was classified as either normal or pathological.

Each participant would be measured at both Achilles tendons and both Patellar tendons (total time 10min) while prone position (for the Achilles tendon) and in sitting position (for Patellar tendon). Each screening is for 45sec.

  • Participants in different ages and different weight status would be measured for tendon structure
  • Tendon structure would be evaluated following single and multiple (up to 12 weeks) aerobic and anaerobic exercises.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
No Intervention: Evaluating Tendons Structures
Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures
Active Comparator: Impact of physical activity on tendons
Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures following different types and different intensity of physical activity
Other: Impact of physical activity on tendons
Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).




Primary Outcome Measures :
  1. Ultrasound tissue characterization [ Time Frame: 10min ]
    Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen


Secondary Outcome Measures :
  1. Ultrasound 3-D visualization of tendon structure [ Time Frame: 10min ]
    measuring the total volume of the tendon; anterior-posterior and medial-lateral diameters



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: - participants should be between the ages of 6 to 30 years; normal-weight, over-weight and obese participants.

Exclusion Criteria:

  • participants that had orthopedic surgery or professional athletes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076073


Contacts
Layout table for location contacts
Contact: Dan Nemet, Prof. 972-9-7471596 Dan.Nemet@clalit.org.il
Contact: Nili Steinberg, PhD 972-9-8639245 knopp@wincol.ac.il

Locations
Layout table for location information
Israel
'Meir children's sport and health center' Recruiting
Kfar-Saba, Israel, 44281
Contact: Dan Nemet, MD    972-9-7471076    dan.nemet@clalit.org.il   
Principal Investigator: Dan Nemet, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Dan Nemet, Prof. Meir Medical Center

Layout table for additonal information
Responsible Party: Dan Nemet, MD, Prof. Dan Nemet, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03076073     History of Changes
Other Study ID Numbers: MeirMc0321-16CTIL
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Nemet, MD, Meir Medical Center:
Ultrasound
Achilles tendon
Patellar tendon
obesity
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms