MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
- Conditions
- Anterior Cruciate Ligament Injury
- Registration Number
- NCT03626857
- Lead Sponsor
- University of Michigan
- Brief Summary
This clinical trial evaluates interventions to maximize muscle function and improve cartilage health following anterior cruciate ligament reconstruction. Improving muscle function may improve patient outcomes, improve joint mechanics, and potentially serve as a prevention approach for post-traumatic knee osteoarthritis. Knee osteoarthritis (OA) is a disabling disease that carries a substantial burden to society and to the individual affected.
- Detailed Description
Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may help prevent the post-traumatic knee osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction. However, a fundamental gap exists in current understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. The investigators pilot work shows that when patients return to activity, quadriceps strength is \~70% of the uninjured side, which is far below the recommended 90%. Further, these data suggest that embedding high-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise into standard of care ACL rehabilitation leads to higher quadriceps strength when compared with standard of care alone. However, the true efficacy of these interventions is unknown, as controlled trials with adequate sample sizes are currently lacking. The absence of this information serves as the driving force and focus of the proposed trial. Therefore, the investigators propose a double-blind randomized controlled trial where ACLR patients will be randomized to 1 of 2 arms. Study arms will include: 1) 8 weeks of NMES+8 weeks of eccentric exercise; 2) 8 weeks of NMES placebo+8 weeks of eccentric placebo. All study arms will receive standard of care ACL rehabilitation in addition to the study interventions. The investigators hypothesize that subjects receiving NMES+eccentric exercise (Arm 1) will realize greater improvements in strength and biomechanical function at 6 months following ACLR than patients in the placebo study arm. Further, the investigators anticipate that patients in the NMES+eccentric exercise arm (Arm 1) will best eliminate negative changes in cartilage health at 18 months following ACLR. This study is innovative, because it employs interventions that directly target the primary mechanisms that result in strength loss following ACLR and will also evaluate whether improving muscle strength can minimize early changes in cartilage health, which may be indicative of future osteoarthritis. The proposed research is significant because it will identify evidence-based treatment approaches that can successfully counteract the muscle weakness which plagues ACLR patients for years after injury and contributes to the onset of post-traumatic osteoarthritis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Acute, complete ACL rupture
- ACL reconstruction with autograft
- Scheduled to undergo ACLR at U of Michigan
- Willingness to participate in testing and follow-up as outlined
- Previous surgery to either knee
- Bony fracture accompanying ACL injury
- Patients who experienced a knee dislocation
- Female participants who are pregnant or planning pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 9 months isokinetic quadriceps strength limb symmetry index 9 months (9 months post-ACL reconstruction) Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
Immediately Post NMES+ECC intervention isokinetic quadriceps strength index Post-NMES+ECC intervention (approximately 16 weeks post-ACL reconstruction) Bilateral concentric isokinetic muscle strength at 60 degrees per second. Limb symmetry index is calculated as (ACL strength/Non-ACL strength)\*100
- Secondary Outcome Measures
Name Time Method T1 rho relaxation time symmetry score for femoral knee joint cartilage 18 months post-ACL reconstruction \[T1rho value at the central weight bearing region of femur from MRI for ACL knee (msec)/T1rho value at the central weight bearing region of femur for NonACL knee (msec)\] x 100
T2 relaxation time symmetry score for femoral knee joint cartilage 18 months post-ACL reconstruction \[T2 value from MRI at the central weight bearing region of femur for the ACL knee (msec)/T2 value from MRI at the central weight bearing region of femur for the NonACL knee (msec)\] x 100
Knee Flexion Angle at 9 months 9 months post-ACL reconstruction Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Knee Flexion Angle at 18 months 18 months post-ACL reconstruction Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Knee Flexion Moment at 9 months 9 months post-ACL reconstruction Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Knee Flexion Moment at 18 months 18 months post-ACL reconstruction Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Trial Locations
- Locations (2)
MedSport
🇺🇸Ann Arbor, Michigan, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
MedSport🇺🇸Ann Arbor, Michigan, United States