Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position

Rupture of Anterior Cruciate Ligament Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02074917
• Other study ID #: HCFMUSP972
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2013
• Last updated: March 14, 2014
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: March 2014
• Source: University of Sao Paulo
• Contact: Arnaldo J Hernandez, PhD, MSc, MD
• Phone: +551126616041
• Email: ajhernandez[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Tear, Knee, Anterior Cruciate Ligament
• Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
• Anatomical ACL reconstruction
Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia do HCFMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Epub 2005 Feb 16. — View 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. Epub 2007 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Stability with force platform	Evaluation of dynamic stability in stand position and leg movements with force platform	12 months	No
Secondary	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	No
Secondary	Change from baseline and between groups in Tegner activity score	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No