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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076073
• Other study ID #: MeirMc0321-16CTIL
• Status: Completed
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: September 29, 2020

Study information

• Verified date: September 2020
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Tendon Thickening

Intervention

Other:
• Impact of physical activity on tendons
Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).

Locations

Country	Name	City	State
Israel	'Meir children's sport and health center'	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound tissue characterization	Based on the stability of echo-pattern the device can discriminate 4 different echo-types of tendon specimen	10min
Secondary	Ultrasound 3-D visualization of tendon structure	measuring the total volume of the tendon; anterior-posterior and medial-lateral diameters	10min