Not provided
Not provided
Not provided
Not provided
Not provided
Study not initiated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal Brace | Experimental | Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee. |
|
| Standard ACLR | Active Comparator | Patients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex Internal Brace | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 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). | Baseline, Month 6 Post-Operation |
| Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at 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). | Baseline, Month 12 Post-Operation |
| Change from Baseline in Lysholm Knee Scoring System Score at 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. | Baseline, Month 6 Post-Operation |
| Change from Baseline in Lysholm Knee Scoring System Score at 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. | Baseline, Month 12 Post-Operation |
| Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at 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. |
Not provided
Not provided
Inclusion Criteria:
• History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guillem Gonzalez-Lomas, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
De-identified participant data will not be available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ACL Reconstruction | Procedure | All patients will undergo ACL reconstruction (ACLR) with or without an internal brace. |
|
| Baseline, Month 6 Post-Operation |
| Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at 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. | Baseline, Month 12 Post-Operation |