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

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ClinicalTrials.gov Identifier: NCT03076073
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dan Nemet, MD, Meir Medical Center

Tracking Information
First Submitted Date  ICMJE March 5, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE May 20, 2017
Actual Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
Ultrasound tissue characterization [ Time Frame: 10min ]
Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
Ultrasound 3-D visualization of tendon structure [ Time Frame: 10min ]
measuring the total volume of the tendon; anterior-posterior and medial-lateral diameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
Official Title  ICMJE Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Obesity, Childhood
  • Obesity
  • Tendon Thickening
Intervention  ICMJE Other: Impact of physical activity on tendons
Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).
Study Arms  ICMJE
  • 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
    Intervention: Other: Impact of physical activity on tendons
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2020)
90
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2017)
100
Actual Study Completion Date  ICMJE September 29, 2020
Actual Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076073
Other Study ID Numbers  ICMJE MeirMc0321-16CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dan Nemet, MD, Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Nemet, Prof. Meir Medical Center
PRS Account Meir Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP