Martin KD, Franz B, Kirsch M, Polanski W, von der Hagen M, Schackert G, Sobottka SB Autologous bone flap cranioplasty following decompressive craniectomy is combined with a high complication rate in pediatric traumatic brain injury patients. Acta Neurochir (Wien). 2014 Apr;156(4):813-24. doi: 10.1007/s00701-014-2021-0. Epub 2014 Feb 16.
Schoekler B, Trummer M Prediction parameters of bone flap resorption following cranioplasty with autologous bone. Clin Neurol Neurosurg. 2014 May;120:64-7. doi: 10.1016/j.clineuro.2014.02.014. Epub 2014 Feb 24.
Shahid AH, Mohanty M, Singla N, Mittal BR, Gupta SK The effect of cranioplasty following decompressive craniectomy on cerebral blood perfusion, neurological, and cognitive outcome. J Neurosurg. 2018 Jan;128(1):229-235. doi: 10.3171/2016.10.JNS16678. Epub 2017 Mar 3.
Stieglitz LH, Fung C, Murek M, Fichtner J, Raabe A, Beck J What happens to the bone flap? Long-term outcome after reimplantation of cryoconserved bone flaps in a consecutive series of 92 patients. Acta Neurochir (Wien). 2015 Feb;157(2):275-80. doi: 10.1007/s00701-014-2310-7. Epub 2014 Dec 24.
Sundseth J, Sundseth A, Berg-Johnsen J, Sorteberg W, Lindegaard KF Cranioplasty with autologous cryopreserved bone after decompressive craniectomy: complications and risk factors for developing surgical site infection. Acta Neurochir (Wien). 2014 Apr;156(4):805-11; discussion 811. doi: 10.1007/s00701-013-1992-6. Epub 2014 Feb 4.
Zins JE, Moreira-Gonzalez A, Papay FA Use of calcium-based bone cements in the repair of large, full-thickness cranial defects: a caution. Plast Reconstr Surg. 2007 Oct;120(5):1332-1342. doi: 10.1097/01.prs.0000279557.29134.cd. Erratum in: Plast Reconstr Surg. 2008 Jan;121(1):347.
Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft
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.
