NCT01048710 - 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)

Takeuchi R, Aratake M, Bito H, Saito I, Kumagai K, Hayashi R, Sasaki Y, Akamatsu Y, Ishikawa H, Amakado E, Aota Y, Saito T
Clinical results and radiographical evaluation of opening wedge high tibial osteotomy for spontaneous osteonecrosis of the knee. Knee Surg Sports Traumatol Arthrosc. 2009 Apr;17(4):361-8. doi: 10.1007/s00167-008-0698-4. Epub 2009 Jan 23.
Takeuchi R, Ishikawa H, Aratake M, Bito H, Saito I, Kumagai K, Akamatsu Y, Saito T
Medial opening wedge high tibial osteotomy with early full weight bearing. Arthroscopy. 2009 Jan;25(1):46-53. doi: 10.1016/j.arthro.2008.08.015. Epub 2008 Oct 10.
Takeuchi R, Saito T, Koshino T
Clinical results of a valgus high tibial osteotomy for the treatment of osteoarthritis of the knee and the ipsilateral ankle. Knee. 2008 Jun;15(3):196-200. doi: 10.1016/j.knee.2008.02.002. Epub 2008 Mar 25.

Treatment of Medial Compartmental Osteoarthritis Grade 1-4 (Kellgren-Lawrence) or Osteonecrosis With TomoFix™ Small or Conservatively

Clinical trial NCT01048710 - References