NCT04992052 - 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)

Moo IH, Chen JYQ, Pagkaliwaga EH, Tan SW, Poon KB
Bone Wax Is Effective in Reducing Blood Loss After Total Knee Arthroplasty. J Arthroplasty. 2017 May;32(5):1483-1487. doi: 10.1016/j.arth.2016.12.028. Epub 2016 Dec 24.
Noble PC, Scuderi GR, Brekke AC, Sikorskii A, Benjamin JB, Lonner JH, Chadha P, Daylamani DA, Scott WN, Bourne RB
Development of a new Knee Society scoring system. Clin Orthop Relat Res. 2012 Jan;470(1):20-32. doi: 10.1007/s11999-011-2152-z.
Shin KH, Choe JH, Jang KM, Han SB
Use of bone wax reduces blood loss and transfusion rates after total knee arthroplasty. Knee. 2020 Oct;27(5):1411-1417. doi: 10.1016/j.knee.2020.07.074. Epub 2020 Aug 19.

A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

Clinical trial NCT04992052 - References