Trial results for a study investigating movement optimization after Anterior Cruciate Ligament (ACL) injury to prevent Knee Osteoarthritis were posted on ClinicalTrials.gov on 2025-12-12, with 34 participants enrolled.
Background
Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop knee osteoarthritis (OA) within 15 years. This condition leads to pain, reduced quality-of-life, and an increased risk for co-morbidity, contributing to substantial healthcare costs and impacting personal responsibilities. Degeneration in articular cartilage, the connective tissue covering bone ends in the knee, is a key indicator of early OA development after knee injury. This deterioration can be measured by an imaging biomarker for OA development.
Trial design
This completed study, designated as Phase NA, enrolled 34 participants with Anterior Cruciate Ligament Injuries and Knee Osteoarthritis. The trial investigated optimizing movement after ACL injury, comparing a Biofeedback Group to a Control Group. The study aimed to gather data on various biomechanical and cartilage health parameters; however, no primary outcomes were listed.
Key results
The trial reported several key measurements across the Biofeedback and Control groups:
- Knee Flexion Moment Impulse:
- Biofeedback Group: mean 0.54 (Standard Deviation 0.28) Ratio and mean 0.66 (Standard Deviation 0.24) Ratio.
- Control Group: mean 0.50 (Standard Deviation 0.21) Ratio and mean 0.54 (Standard Deviation 0.21) Ratio.
- Cartilage T2 Relaxation Time:
- Biofeedback Group: mean 6.63 (Standard Deviation 3.50) Percent Change.
- Control Group: mean 5.86 (Standard Deviation 2.99) Percent Change.
- Vertical Ground Reaction Force Impulse:
- Biofeedback Group: mean 0.91 (Standard Deviation 0.08) Ratio and mean 0.95 (Standard Deviation 0.08) N/A (Ratio).
- Control Group: mean 0.84 (Standard Deviation 0.11) Ratio and mean 0.86 (Standard Deviation 0.10) N/A (Ratio).
- Peak Knee Flexion Moment:
- Biofeedback Group: median 0.6 Ratio.
- Control Group: median 0.7 Ratio.
Statistical analyses performed included ANCOVA, with p-values of 0.293, 0.114, 0.017, and 0.021. Wilcoxon (Mann-Whitney) analyses yielded p-values of 0.936 and 0.867.
What this means
The posted results provide specific biomechanical and cartilage health measurements from a study focused on optimizing movement after ACL injury to potentially mitigate the development of knee osteoarthritis. While several p-values from ANCOVA analyses were reported as statistically significant (0.017 and 0.021), the specific outcomes to which these significant p-values correspond are not detailed in the available data. The data offers insights into various parameters in both biofeedback and control groups, contributing to the understanding of interventions aimed at preventing post-traumatic OA.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05363683, titled "Optimizing Movement After Anterior Cruciate Ligament Injury", were posted on 2025-12-12 on clinicaltrials.gov.