NCT05521126

Brief Summary

The purpose of this study is to see if the study team can use micro-Doppler signal (MDS) technology to determine if someone has had an anterior cruciate ligament (ACL) reconstruction. The investigators will do this by comparing the movement data from a group of people who have had the surgery with a group who has not had the surgery to see if the micro-Doppler radar technology can accurately and predictably tell the difference.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2023Jun 2026

First Submitted

Initial submission to the registry

August 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

August 26, 2022

Last Update Submit

September 24, 2025

Conditions

Keywords

musculoskeletal injuryanterior cruciate ligament injuryanterior cruciate ligament repairmicro-Doppler radarmotion capture

Outcome Measures

Primary Outcomes (1)

  • accuracy and predictability of MDS differentiation between ACL repair and control group

    The investigators hypothesize that MDS will differentiate subjects who have recovered from an ACL reconstruction from a control cohort with accuracy and predictability. Participants will perform drop jumps, sit to stand, and walk on a treadmill in the presence of the micro-Doppler radar. MDS will be obtained for the ACL group as well as control. The micro-Doppler signature projection algorithm (mD-SPA) will then be applied to the data sets showing what percentage of the MDS are successfully classified to the ACL group versus control.

    Day 1

Secondary Outcomes (2)

  • accuracy of MDS differentiation between ACL repair and control groups versus the motion capture system

    Day 1

  • ability of micro-Doppler radar and deep learning algorithms to automatically produce predictive data

    Day 1

Study Arms (2)

high risk/ACL repair cohort

The high risk cohort will be subjects who have had an ACL reconstruction procedure 9-24 months prior to enrollment.

control group

The control group will be individuals who have not had an ACL reconstruction procedure.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ACL repair cohort: Penn State Health Bone and Joint clinic control cohort: Penn State University/College of Medicine students and employees, Lebanon Valley College students, community sample

You may qualify if:

  • High risk cohort
  • age 18-40
  • history of ACL reconstruction
  • no current musculoskeletal injuries
  • ACL repair between 9 and 24 months prior to recruitment
  • Control cohort
  • age 18-40
  • never had lower extremity surgery

You may not qualify if:

  • High risk cohort
  • age \<18 or \>40
  • pregnancy
  • institutionalization
  • history of cerebral vascular accident
  • unable to provide informed consent
  • inability to perform study activities
  • history of hip or knee replacement
  • inability to walk or jump without a limp
  • current neuromuscular disease
  • any surgery in the last 6 months
  • Control cohort
  • age \< 18 or \> 40
  • pregnancy
  • institutionalization
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lebanon Valley College

Annville, Pennsylvania, 17003, United States

Location

Pennsylvania State University College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Cayce A Onks, DO, MS

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Family Medicine and Orthopaedics

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 30, 2022

Study Start

February 21, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

September 30, 2025

Record last verified: 2025-04

Locations