search
Back to results

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

Primary Purpose

Obesity, Childhood, Obesity, Tendon Thickening

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Impact of physical activity on tendons
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity, Childhood focused on measuring Ultrasound, Achilles tendon, Patellar tendon, obesity

Eligibility Criteria

6 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 'Meir children's sport and health center'

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Evaluating Tendons Structures

Impact of physical activity on tendons

Arm Description

Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures

Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures following different types and different intensity of physical activity

Outcomes

Primary Outcome Measures

Ultrasound tissue characterization
Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen

Secondary Outcome Measures

Ultrasound 3-D visualization of tendon structure
measuring the total volume of the tendon; anterior-posterior and medial-lateral diameters

Full Information

First Posted
March 5, 2017
Last Updated
September 29, 2020
Sponsor
Meir Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03076073
Brief Title
Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
Official Title
Ultrasonography of the Patellar Tendon and Achilles Tendon in Children Adolescent and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
September 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Obesity, Tendon Thickening
Keywords
Ultrasound, Achilles tendon, Patellar tendon, obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluating Tendons Structures
Arm Type
No Intervention
Arm Description
Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures
Arm Title
Impact of physical activity on tendons
Arm Type
Active Comparator
Arm Description
Ultrasound measurements of Patellar Tendon and Achilles Tendon Structures following different types and different intensity of physical activity
Intervention Type
Other
Intervention Name(s)
Impact of physical activity on tendons
Intervention Description
Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).
Primary Outcome Measure Information:
Title
Ultrasound tissue characterization
Description
Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen
Time Frame
10min
Secondary Outcome Measure Information:
Title
Ultrasound 3-D visualization of tendon structure
Description
measuring the total volume of the tendon; anterior-posterior and medial-lateral diameters
Time Frame
10min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, Prof.
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
'Meir children's sport and health center'
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs