NCT04559399 - 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)

Bell DF, Ehrlich MG, Zaleske DJ
Brace treatment for symptomatic spondylolisthesis. Clin Orthop Relat Res. 1988 Nov;(236):192-8.
Bonnici AV, Koka SR, Richards DJ
Results of Buck screw fusion in grade I spondylolisthesis. J R Soc Med. 1991 May;84(5):270-3.
Chen XS, Zhou SY, Jia LS, Gu XM, Fang L, Zhu W
A universal pedicle screw and V-rod system for lumbar isthmic spondylolysis: a retrospective analysis of 21 cases. PLoS One. 2013 May 17;8(5):e63713. doi: 10.1371/journal.pone.0063713. Print 2013.
Debnath UK, Freeman BJ, Gregory P, de la Harpe D, Kerslake RW, Webb JK
Clinical outcome and return to sport after the surgical treatment of spondylolysis in young athletes. J Bone Joint Surg Br. 2003 Mar;85(2):244-9. Review.
Herman MJ, Pizzutillo PD, Cavalier R
Spondylolysis and spondylolisthesis in the child and adolescent athlete. Orthop Clin North Am. 2003 Jul;34(3):461-7, vii. Review.
Karatas AF, Dede O, Atanda AA, Holmes L Jr, Rogers K, Gabos P, Shah SA
Comparison of Direct Pars Repair Techniques of Spondylolysis in Pediatric and Adolescent Patients: Pars Compression Screw Versus Pedicle Screw-Rod-Hook. Clin Spine Surg. 2016 Aug;29(7):272-80. doi: 10.1097/BSD.0b013e318277cb7d.
Standaert CJ, Herring SA
Spondylolysis: a critical review. Br J Sports Med. 2000 Dec;34(6):415-22. Review.
Widi GA, Williams SK, Levi AD
Minimally invasive direct repair of bilateral lumbar spine pars defects in athletes. Case Rep Med. 2013;2013:659078. doi: 10.1155/2013/659078. Epub 2013 Apr 30.

Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis

Clinical trial NCT04559399 - References