ACL Injury
Conditions
Brief summary
The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing.
Detailed description
The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.
Interventions
DEVICEArthrex Internal Brace
The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
PROCEDUREACL Reconstruction
All patients will undergo ACL reconstruction (ACLR) with or without an internal brace.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Exclusion criteria
* Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy. * History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation | Baseline, Month 6 Post-Operation | The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). |
| Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation | Baseline, Month 12 Post-Operation | The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). |
| Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation | Baseline, Month 6 Post-Operation | The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor. |
| Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation | Baseline, Month 12 Post-Operation | The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor. |
| Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation | Baseline, Month 6 Post-Operation | Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score. |
| Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation | Baseline, Month 12 Post-Operation | Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score. |
Countries
United States
Outcome results
None listed