N/A
N=150
Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes
Rehabilitation · ACL Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT03190889 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With Second ACL Injury — 3; 7; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HOME (Other); TNMT (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Second ACL Injury |
3; 7; 5 | — |
| SECONDARY Frontal Plane Knee Kinetics |
— | — |
| SECONDARY Frontal Plane Knee Kinematics |
— | — |
Summary
The overall goal of this project is to reduce risk of second anterior cruciate ligament (ACL) injury in vulnerable populations (active athletes between 14 = 24 years old) through the identification of relative injury risk groups based on subject-specific movement patterns prior to second injury, as well as through the determination of effect for differential rehabilitation protocols following initial ACL reconstruction and prior to return to sport. As nearly one-third of athletes who have a primary ACL injury and return to sport will experience a secondary injury, results from the proposed work will allow us to prospectively identify high risk patients who are the most appropriate recipients of enhanced treatment, including targeted training, which may reduce the risk of second ACL injury. Secondary ACL injury has the potential to end athletic careers, promote the development of osteoarthritis, and have debilitating effects on quality of life. Hence, the information gathered in this investigation will offer ACL injured athletes the optimal potential to reduce or potentially prevent these negative health effects before they are initiated.
Eligibility Criteria
Inclusion Criteria
- Age, 13 ≥ 30 years
- Acute (< 6 months), first-time, isolated ACL injury
- No history of previous knee surgery to either extremity
- No low back or lower extremity injury in the year prior to ACL injury necessitating medical care
- Pre-injury participation in cutting, jumping or pivoting sports for ≥ 50 hours/year
- Mechanism of injury did not involve a direct blow to the knee.
- Patients who sustain a medial collateral ligament (MCL) injury are eligible for study participation if medial knee instability is resolved prior to surgery
- Patients with simple meniscus tears (i.e., 2 cm vertical longitudinal tear) that do not necessitate alterations in rehabilitation will be eligible for study participation
Exclusion Criteria
- History of previous knee surgery to either extremity
- Low back or lower extremity injury in the year prior to ACL injury necessitating medical care
- Second or greater ACL injury
- Greater than 6 months since occurrence of ACL injury
- Lack of participation in cutting, jumping, or pivoting sport
- Mechanisms of injury involved a direct blow of force to the knee
- Patients with MCL injury that exhibits unresolved medial knee instability
- Patients with complex, repairable meniscus tears (i.e., radial or root repair) and patients with full thickness articular cartilage lesions will not be eligible for participation secondary to significant alterations to postoperative rehabilitation protocol
Data sourced from ClinicalTrials.gov (NCT03190889). 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.