Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551678
• Other study ID #: 46025
• Secondary ID: CDMRP-PR171647
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: VA Palo Alto Health Care System
• Contact: Jennifer Hledik, PhD
• Phone: 650-493-5000
• Email: jerhart[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• age 18-40 years

• history of primary ACLR with or without meniscal repair

• full weight-bearing status

• neutral to varus knee alignment

• plans to remain in the area for at least 8 months.

Exclusion Criteria:

• Kellgren-Lawrence (KL) radiographic grade > 2

• additional injury or surgery to the involved knee

• BMI >30 kg/m2

• use of walking, orthopedic, or prosthetic assistive device

• pregnancy

• inability to have MRI

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Inflammation

Intervention

Device:
• Active feedback gait retraining
The device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.

Locations

Country	Name	City	State
United States	VA Palo Alto	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Adduction Moment	Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining	Change from baseline to immediately after 8 weeks of retraining
Secondary	Medial knee compartment qMRI	Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading	Change from baseline to 6 months after retraining
Secondary	Knee Adduction Moment	Knee Joint Loading (%Bw*Ht)	Change from baseline to 3 months after retraining
Secondary	Knee Adduction Moment	Knee Joint Loading (%Bw*Ht)	Change from baseline to 6 months after retraining
Secondary	Serum inflammatory markers	Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading	Change from baseline to immediately after 8 weeks of retraining