MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 14 - 40 |
| Updated: | 3/2/2019 |
| Start Date: | February 22, 2019 |
| End Date: | September 30, 2023 |
| Contact: | Riann M Palmieri-Smith, PhD |
| Email: | riannp@umich.edu |
| Phone: | 734-615-3154 |
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.
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.
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 4
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 exercise; 3) 8 weeks of NMES+8 weeks of eccentric
placebo; and 4) 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 other 3 study arms. 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.
(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 4
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 exercise; 3) 8 weeks of NMES+8 weeks of eccentric
placebo; and 4) 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 other 3 study arms. 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous surgery to either knee
- Bony fracture accompanying ACL injury
- Full thickness articular cartilage lesion
- Delayed ACLR (> 5 weeks between ACL injury and ACLR)
- Patients who experienced a knee dislocation
- Female participants who are pregnant or planning pregnancy
We found this trial at
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