Skip to main content
Clinical Trials/NCT05363683
NCT05363683CompletedNot Applicable

Optimizing Movement After Anterior Cruciate Ligament Injury

University of Nebraska1 site in 1 country34 target enrollmentStarted: November 11, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Cartilage T2 Relaxation Time

Study Overview

Brief Summary

Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop knee osteoarthritis (OA) within 15 years. The resulting pain, reduced quality-of-life, and increased risk for co-morbidity lead to substantial healthcare costs, inability to fulfill work and personal responsibilities, and reduced long-term health. Degeneration in articular cartilage, connective tissue that covers the ends of bones in the knee, is the hallmark of early OA development after knee injury. This deterioration can be measured by an imaging biomarker for OA development on quantitative magnetic resonance imaging (MRI). Harmful increases in MRI markers of the knee's articular cartilage occur within months of ACL injury and indicate preventative interventions should begin soon after injury. However, evidence-based interventions to prevent OA do not exist.

This project will challenge the traditional OA paradigm that too much joint loading (e.g. "wear and tear") causes cartilage breakdown. A multi-disciplinary team has developed a novel visual biofeedback paradigm using portable force plates that can increase knee loading during squats within a single session after ACL reconstruction (ACLR). This study will determine the efficacy of the visual biofeedback program initiated two weeks after ACLR by assessing movement biomechanics and MRI changes in cartilage after six months later. Successful completion of this project will establish the first rehabilitation intervention to effectively and optimally load the knee joint early after ACLR, providing the initial steps to prevent OA after ACL injury.

Detailed Description

Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop radiographic knee osteoarthritis (OA) within 15 years. The resulting pain, reduced quality-of-life, and increased risk for co-morbidity lead to substantial healthcare costs, inability to fulfill work and personal responsibilities, and reduced long-term health. Degeneration in articular cartilage, connective tissue that covers the ends of bones in the knee, is the hallmark of early OA development after knee injury. This deterioration can be measured by increased T2 and T1rho relaxation time on quantitative magnetic resonance imaging (MRI), an imaging biomarker for OA development. Harmful increases in MRI markers of the knee's articular cartilage occur within months of ACL injury and indicate preventative interventions should begin soon after injury. However, evidence-based interventions to prevent OA do not exist. The investigators have shown that after ACL reconstruction (ACLR), patients exhibit asymmetric movement patterns characterized by up to 62% lower knee joint loading during walking and squatting in the injured limb at two months after ACLR. These knee joint loading patterns remain 40% lower at six months. Emerging evidence suggests knee joint unloading patterns after ACL injury may increase the risk for OA development. Currently, no studies have examined the efficacy of movement-focused interventions during the first months after ACLR, which explains the lack of evidence-based interventions that successfully increase knee loading early after ACLR. This gap presents a barrier to the long-term goal of preventing OA in young, active individuals before irreversible knee degeneration occurs. This project will challenge the traditional OA paradigm that too much joint loading (e.g. "wear and tear") causes cartilage breakdown. The multi-disciplinary team spanning rehabilitation, orthopaedics, radiology and biomechanics has developed a novel visual biofeedback paradigm using portable force plates that can increase knee loading during squats within a single session after ACLR. This data suggest movement is modifiable using visual feedback, but its efficacy beyond a single training session is unknown. This study will determine the efficacy of the visual biofeedback program initiated two weeks after ACLR by assessing movement biomechanics and MRI changes in cartilage microstructure six months later. Successful completion of this project will establish the first rehabilitation intervention to effectively and optimally load the knee joint early after ACLR, providing the initial steps in the team's work to prevent OA after ACL injury.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to 35 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Acute anterior cruciate ligament (ACL) injury in the past 6 months
  • ACL reconstruction in the past month or have a planned ACL reconstruction

Exclusion Criteria

  • Previous knee injury or surgery (contralateral knee)
  • Body mass index (BMI) over 35 kg/m2
  • Concomitant posterior cruciate ligament reconstruction or cartilage procedure that includes extended weight bearing restrictions and/or changes to cartilage structure
  • Current or planned pregnancy during study duratuiom

Arms & Interventions

Control

Active Comparator

Standard care

Intervention: Standard Care (Procedure)

Experimental

Experimental

Squat biofeedback intervention

Intervention: Squat Biofeedback (Procedure)

Outcomes

Primary Outcomes

Cartilage T2 Relaxation Time

Time Frame: Baseline (immediately before intervention, 2-6 weeks after anterior cruciate ligament reconstruction) and 6 months after anterior cruciate ligament reconstruction.

Percent change in cartilage T2 relaxation time will be measured by a magnetic resonance imaging (MRI) scan. A positive percent change represents longer (worse) T2 relaxation times at 6 months compared to baseline testing. The cartilage region reported is the weightbearing area of the medial femoral condyle.

Knee Flexion Moment Impulse

Time Frame: Immediately post-intervention (within approximately 1 week after completing intervention)

Participants completed 3 sets of 5 bilateral bodyweight squats with arms crossed at the chest, with the middle 3 of each set (9 total) averaged and reported. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the knee flexion moment impulse during descent and ascent of bilateral squatting was analyzed at post-intervention. A value of 1 represents symmetric knee flexion moment impulse; a value less than 1 represents a smaller knee flexion moment impulse in the injured compared to uninjured limb.

Secondary Outcomes

  • Vertical Ground Reaction Force Impulse(Immediately post-intervention (approximately 1 week after intervention))
  • Peak Knee Flexion Moment(Immediately post-intervention (within approximately 1 week after completing intervention))
  • Quadriceps Strength(Immediately post-intervention (within approximately 1 week after completing intervention))
  • Knee Flexion Moment Impulse(6 months after anterior cruciate ligament reconstruction.)
  • Vertical Ground Reaction Force Impulse(6 months after anterior cruciate ligament reconstruction.)
  • Peak Knee Flexion Moment(6 months after anterior cruciate ligament reconstruction.)
  • Quadriceps Strength(6 months after anterior cruciate ligament reconstruction.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials