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This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction.
One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately.
This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.
It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.
Tunnel position will be recorded and confirmed with postoperative computer tomography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AM anatomical ACL reconstruction | Experimental | Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction |
|
| CENTRAL anatomical ACL reconstruction | Experimental | Femoral and tibial tunnels performed in the center of ACL footprint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomical ACL reconstruction | Procedure | Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Stability with force platform | Evaluation of dynamic stability in stand position and leg movements with force platform | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline and between groups in Lysholm knee scoring scale | This is a validated scoring scale to evaluate outcomes of knee ligament surgery, particularly symptoms of instability. The total score is the sum of each response to the 8 items, of a possible score of 100. | 6, 12, 24 months |
| Change from baseline and between groups in Tegner activity score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaldo J Hernandez, PhD, MSc, MD | Contact | +551126616041 | ajhernandez@uol.com.br | |
| Danilo RO Oliveira, Phisycian | Contact | +5511983697729 | ortopedistadanilo@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Arnaldo J Hernandez, PhD, MSc, MD | University of Sao Paulo | Principal Investigator |
| Danilo RO Oliveira, MD | University of Sao Paulo | Study Director |
| Tiago L Fernandes, MSc, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ortopedia e Traumatologia do HCFMUSP | Recruiting | São Paulo | São Paulo | 05403010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17932407 | Background | Zantop T, Wellmann M, Fu FH, Petersen W. Tunnel positioning of anteromedial and posterolateral bundles in anatomic anterior cruciate ligament reconstruction: anatomic and radiographic findings. Am J Sports Med. 2008 Jan;36(1):65-72. doi: 10.1177/0363546507308361. Epub 2007 Oct 11. | |
| 21316972 | Background | Misonoo G, Kanamori A, Ida H, Miyakawa S, Ochiai N. Evaluation of tibial rotational stability of single-bundle vs. anatomical double-bundle anterior cruciate ligament reconstruction during a high-demand activity - a quasi-randomized trial. Knee. 2012 Mar;19(2):87-93. doi: 10.1016/j.knee.2011.01.003. Epub 2011 Feb 12. |
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|
This is a validated score for level of activity related to knee stability. It provides a standardized method of grading work and sporting activities from 0 to 10. |
| 6, 12, 24 months |
| Single leg hop test for distance - side to side difference | This test includes a single leg hop for distance comparison between involved leg vs. contra-lateral normal leg. Results are expressed as a percentage of the non-involved leg. | 6, 12 months |
| Isokinetic knee strength test - side to side difference | Quadriceps and hamstring isokinetic strength are assessed at velocities of 60 and 240 degrees per second and values are compared between involved operated leg and non-involved leg and between groups. Peak torque and flexion/extension rate are analyzed. | 6, 12 months |
| Change from baseline and between groups in Dynamic Stability with force platform | Evaluation of dynamic stability in stand position and leg movements with force platform. Antero-posterior and latero-medial movements are measured in metric scale. Area and velocity of movement are also calculated. | 6 months |
| Change from baseline and between groups in International Knee Documentation Committee form (IKDC) | The form is used to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. It is a validated 18-item patient measurement tool. that can be used for post-operatory ACL reconstruction | 6, 12 e 24 months |
| University of Sao Paulo |
| Study Director |
| Ellen CR Felix | University of Sao Paulo | Study Director |
| 20516317 | Background | Forsythe B, Kopf S, Wong AK, Martins CA, Anderst W, Tashman S, Fu FH. The location of femoral and tibial tunnels in anatomic double-bundle anterior cruciate ligament reconstruction analyzed by three-dimensional computed tomography models. J Bone Joint Surg Am. 2010 Jun;92(6):1418-26. doi: 10.2106/JBJS.I.00654. |
| 15722268 | Background | Musahl V, Plakseychuk A, VanScyoc A, Sasaki T, Debski RE, McMahon PJ, Fu FH. Varying femoral tunnels between the anatomical footprint and isometric positions: effect on kinematics of the anterior cruciate ligament-reconstructed knee. Am J Sports Med. 2005 May;33(5):712-8. doi: 10.1177/0363546504271747. Epub 2005 Feb 16. |
| 22124847 | Background | Mohammadi F, Salavati M, Akhbari B, Mazaheri M, Khorrami M, Negahban H. Static and dynamic postural control in competitive athletes after anterior cruciate ligament reconstruction and controls. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1603-10. doi: 10.1007/s00167-011-1806-4. Epub 2011 Nov 29. |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D007718 | Knee Injuries |
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D059549 | Anterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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