NCT03061279 - 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)

Amanatullah DF, Khan SN, Curtiss S, Wolinsky PR
Effect of divergent screw fixation in vertical medial malleolus fractures. J Trauma Acute Care Surg. 2012 Mar;72(3):751-4. doi: 10.1097/TA.0b013e31823b8b9f.
Amanatullah DF, McDonald E, Shellito A, Lafazan S, Cortes A, Curtiss S, Wolinsky PR
Effect of mini-fragment fixation on the stabilization of medial malleolus fractures. J Trauma Acute Care Surg. 2012 Apr;72(4):948-53. doi: 10.1097/TA.0b013e318249697d.
Amanatullah DF, Wolinsky PR
An alternative fixation technique for small medial malleolus fractures. Orthopedics. 2010 Dec;33(12):888. doi: 10.3928/01477447-20101021-17.
Brown OL, Dirschl DR, Obremskey WT
Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15(4):271-4.
Dumigan RM, Bronson DG, Early JS
Analysis of fixation methods for vertical shear fractures of the medial malleolus. J Orthop Trauma. 2006 Nov-Dec;20(10):687-91.
Hung M, Baumhauer JF, Latt LD, Saltzman CL, SooHoo NF, Hunt KJ; National Orthopaedic Foot & Ankle Outcomes Research Network
Validation of PROMIS ® Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research. Clin Orthop Relat Res. 2013 Nov;471(11):3466-74. doi: 10.1007/s11999-013-3097-1.
Rovinsky D, Haskell A, Liu Q, Paiement GD, Robinovitch S
Evaluation of a new method of small fragment fixation in a medial malleolus fracture model. J Orthop Trauma. 2000 Aug;14(6):420-5.
Toolan BC, Koval KJ, Kummer FJ, Sanders R, Zuckerman JD
Vertical shear fractures of the medial malleolus: a biomechanical study of five internal fixation techniques. Foot Ankle Int. 1994 Sep;15(9):483-9.

Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

Details for clinical trial NCT03061279

Clinical trial NCT03061279 - References