Spine Fusion — Prospective Study on Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients
Citation(s)
Dehoux E, Fourati E, Madi K, Reddy B, Segal P Posterolateral versus interbody fusion in isthmic spondylolisthesis: functional results in 52 cases with a minimum follow-up of 6 years. Acta Orthop Belg. 2004 Dec;70(6):578-82.
Etemadifar MR, Hadi A, Masouleh MF Posterolateral instrumented fusion with and without transforaminal lumbar interbody fusion for the treatment of adult isthmic spondylolisthesis: A randomized clinical trial with 2-year follow-up. J Craniovertebr Junction Spine. 2016 Jan-Mar;7(1):43-9. doi: 10.4103/0974-8237.176623.
Gaines RW Jr The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. Review.
GILL GG, MANNING JG, WHITE HL Surgical treatment of spondylolisthesis without spine fusion; excision of the loose lamina with decompression of the nerve roots. J Bone Joint Surg Am. 1955 Jun;37-A(3):493-520.
Jacobs WC, Vreeling A, De Kleuver M Fusion for low-grade adult isthmic spondylolisthesis: a systematic review of the literature. Eur Spine J. 2006 Apr;15(4):391-402. Epub 2005 Oct 11. Review.
Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine (Phila Pa 1976). 2009 Jan 15;34(2):199-205. doi: 10.1097/BRS.0b013e31818edcfd.
McGuire RA, Amundson GM The use of primary internal fixation in spondylolisthesis. Spine (Phila Pa 1976). 1993 Sep 15;18(12):1662-72.
McTimoney CA, Micheli LJ Current evaluation and management of spondylolysis and spondylolisthesis. Curr Sports Med Rep. 2003 Feb;2(1):41-6. Review.
Möller H, Hedlund R Instrumented and noninstrumented posterolateral fusion in adult spondylolisthesis--a prospective randomized study: part 2. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1716-21.
Osterman K, Schlenzka D, Poussa M, Seitsalo S, Virta L Isthmic spondylolisthesis in symptomatic and asymptomatic subjects, epidemiology, and natural history with special reference to disk abnormality and mode of treatment. Clin Orthop Relat Res. 1993 Dec;(297):65-70.
STEWART TD [The age incidence of neural-arch defects in Alaskan natives, considered from the standpoint of etiology]. J Bone Joint Surg Am. 1953 Oct;35-A(4):937-50. Undetermined Language.
Thomsen K, Christensen FB, Eiskjaer SP, Hansen ES, Fruensgaard S, Bünger CE 1997 Volvo Award winner in clinical studies. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: a prospective, randomized clinical study. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2813-22.
Prospective Study on Clinical and Radiological Results With Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
