Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position
NCT ID: NCT02074917
Last Updated: 2014-03-18
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2012-10-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AM anatomical ACL reconstruction
Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction
Anatomical ACL reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
CENTRAL anatomical ACL reconstruction
Femoral and tibial tunnels performed in the center of ACL footprint
Anatomical ACL reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
Interventions
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Anatomical ACL reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absence of other associated ligament injuries in the operated knee
* No ACL rerupture or previous ACL reconstruction in the same or other knee
* Absence of untreated lesions of the opposite knee
* No obvious change in the alignment of the mechanical axis that required surgical correction
* Athletes of both gender with a minimum age of 18 years and maximum of 45 years
* Signature of the consent term (IRB)
* Not be pregnant.
Exclusion Criteria
* Fracture not associated with the surgical procedure
* Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.
18 Years
45 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Arnaldo José Hernandez
Associate Professor, PhD, MSc, MD
Principal Investigators
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Arnaldo J Hernandez, PhD, MSc, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Danilo RO Oliveira, MD
Role: STUDY_DIRECTOR
University of Sao Paulo
Tiago L Fernandes, MSc, MD
Role: STUDY_DIRECTOR
University of Sao Paulo
Ellen CR Felix
Role: STUDY_DIRECTOR
University of Sao Paulo
Locations
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Instituto de Ortopedia e Traumatologia do HCFMUSP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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HCFMUSP972
Identifier Type: -
Identifier Source: org_study_id
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