NCT02074917 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.
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.

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

Details for clinical trial NCT02074917

Clinical trial NCT02074917 - References