Effects of a Valgus Unloader Brace on Medial Femoral Cartilage

NCT03272672 | Completed

• 1 other identifier: 17-0831
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of a valgus unloader brace condition on the acute change in medial femoral condyle cartilage morphology using Ultrasound following a standardized walking protocol.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pre walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound

  Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters

  Prior to the walking protocol

• Post walking - Thickness (mm) of the Medial Femoral Articular Cartilage as measured by ultrasound

  Thickness of the articular cartilage on the Medial Femoral condyle will be measured in millimeters

  Immediately following the walking protocol (the post-test will be finished within approximately 5 minutes of concluding the walking protocol)

Study Arms (2)

Braced

EXPERIMENTAL

Össür Unloading Knee Brace used during walking protocol

Other: Össür Unloading Knee Brace

Unbraced

NO INTERVENTION

Walking protocol without the use of brace

Interventions

Össür Unloading Knee Brace OTHER

During the braced walking condition, a valgus unloader brace (Össür Unloader One®, Össur Americas, Orange County, CA) will be fitted by a certified athletic trainer per manufacturer instructions to the dominant limb while the participant is seated with knee flexed to approximately 80°. The brace will be maximally adjusted to unload the medial compartment.

Also known as: Össür Unloader One®

Braced

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• congenital or degenerative joint condition, orthopedic implants, current joint pain (quantified as less than 2 on a 10cm visual analog scale),
• cartilage injury of any joint, lower extremity fracture, or upper extremity fracture within the last year.
• any major ligamentous or cartilage injury of the knee or hip joints, or reported of cartilage injury at the ankle.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Joshua Valentine

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Brian Pietrosimone, PhD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded investigator will segment all Ultrasound images.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 5, 2017
• Study Start: September 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (1)