Clinical trial NCT02074917: Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position
Official title: Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical Single-bundle ACL at Anteromedial or Central Tunnel Position - Prospective, Randomized and Double-blind Clinical Trial in Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Complete Tear, Knee, Anterior Cruciate Ligament
Keywords: anterior cruciate ligament
ACL
anterior cruciate ligament reconstruction
outcome assessment
outcome assessment, patient
treatment outcome
exercise test
anatomic
anatomical
single-bundle
force platform
postural balance
biomechanics
CT scan
X-ray computed tomography
tomography
diagnostic imaging
knee
knee injuries
joint instability
reconstructive surgical procedures
knee surgery
arthroscopy
athletes
sports medicine
humans
prospective studies
Randomized Controlled Trial
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Tunnel position will be recorded and confirmed with postoperative computer tomography.

Eligibility criteria: Inclusion Criteria:

* Physical activity classified by Tegner scale ≥ 5
* 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:

* Request to stop the study by patient at any time
* Fracture not associated with the surgical procedure
* Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.

Primary outcomes:
measure: Dynamic Stability with force platform
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline and between groups in Lysholm knee scoring scale
timeFrame: 6, 12, 24 months
measure: Change from baseline and between groups in Tegner activity score
timeFrame: 6, 12, 24 months
measure: Single leg hop test for distance - side to side difference
timeFrame: 6, 12 months
measure: Isokinetic knee strength test - side to side difference
timeFrame: 6, 12 months
measure: Change from baseline and between groups in Dynamic Stability with force platform
timeFrame: 6 months
measure: Change from baseline and between groups in International Knee Documentation Committee form (IKDC)
timeFrame: 6, 12 e 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia do HCFMUSP
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Arnaldo J Hernandez, PhD, MSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Danilo RO Oliveira, MD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Tiago L Fernandes, MSc, MD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Ellen CR Felix
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.