N/A N=7 Treatment

Preventing Posttraumatic Osteoarthritis With Physical Activity Promotion

Anterior Cruciate Ligament Injuries · Exercise · Cartilage, Articular · Knee Injuries · Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT04906499 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: T1rho Relaxation Times in the Medial Femoral Condyle at Baseline — 53.48 ms

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Physical Activity Promotion (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY T1rho Relaxation Times in the Medial Femoral Condyle at Baseline	53.48	—
PRIMARY T1rho Relaxation Times in the Medial Femoral Condyle Post-intervention	52.98	—
PRIMARY T1rho Relaxation Times in the Lateral Femoral Condyle at Baseline	51.40	—
PRIMARY T1rho Relaxation Times in the Lateral Femoral Condyle Post-intervention	50.60	—
PRIMARY T1rho Relaxation Times in the Medial Tibial Condyle at Baseline	54.48	—
PRIMARY T1rho Relaxation Times in the Medial Tibial Condyle Post-intervention	53.38	—
PRIMARY T1rho Relaxation Times in the Lateral Tibial Condyle at Baseline	51.69	—
PRIMARY T1rho Relaxation Times in the Lateral Tibial Condyle Post-intervention	50.51	—
PRIMARY Change in Daily Steps	2054	—
PRIMARY Change in T1rho Relaxation Times in the Medial Femoral Condyle	-0.50	—
PRIMARY Change in T1rho Relaxation Times in the Medial Tibial Condyle	-1.11	—
PRIMARY Change in T1rho Relaxation Times in the Lateral Femoral Condyle	-0.81	—
PRIMARY Change in T1rho Relaxation Times in the Lateral Tibial Condyle	-1.18	—
SECONDARY Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale	69.8	—
SECONDARY Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale	69.8	—

Summary

Osteoarthritis (OA) is a leading cause of disability worldwide that affects millions of Americans each year. Posttraumatic OA (PTOA) significantly impacts patients after anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) with approximately 50% of patients developing PTOA within 20 years of injury or surgery. Knee joint mechanical loading measured via physical activity (i.e. daily steps) is insufficient in individuals after ACLR compared to uninjured individuals. Establishing the beneficial effects of physical activity to promote optimal free-living knee joint mechanical loading and improve knee joint health will aid in the development of cost-effective interventions that prevent PTOA and health burden of the disease.

Eligibility Criteria

Inclusion Criteria

Participants will be included if they:

Provide informed consent and sign a HIPPA form prior to any study procedures are performed
Have completed all other formal physical therapy and therapeutic exercise regimens, and will not be engaging in any other formal therapy for their ACLR during the study
Are between the ages of 18 and 35.
Underwent an ACLR no earlier than 6 months and no later than 5 years prior to enrollment.
Demonstrate < 8, 000 steps per day during the screening phase of the study as assessed using the Actigraph GT9X Link monitor.
Demonstrate clinically relevant-knee symptoms, defined as a Knee Injury and Osteoarthritis Outcomes Score (KOOS) quality of life subscale < 72.2

Exclusion Criteria

Participants will be excluded if:

The participant underwent an ACLR revision surgery due to a previous ACL graft injury.
Multiple ligament surgery was indicated at the time of ACLR surgery.
A lower extremity fracture was suffered during the ACL injury.
The participant has been diagnosed with osteoarthritis in either knee
They have a cochlear implant, metal in body, claustrophobia, or history of seizures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04906499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.