Comparison anterior minimally invasive oblique retroperitoneal approach and posterior transpedicular approach for debridement fusion in patients with lumbar vertebral osteomyelitis: A randomized controlled trial protocol.
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
30 Oct 2020
30 Oct 2020
Historique:
entrez:
31
10
2020
pubmed:
1
11
2020
medline:
18
11
2020
Statut:
ppublish
Résumé
Pyogenic osteomyelitis of the spine usually occurs in patients over 55 years old with acute osteomyelitis. Surgical treatment and fixation can relieve pain, enhance spinal balance and nerve function, so that patients can walk as soon as possible. Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA). While, there is no consensus on the best treatment for PVO. The goal of the protocol is to compare the clinical consequences between PTA and ORA for treating PVO. The experiment is a single-center randomized clinical research. This experiment was admitted by the Ethics Committee of the People's Hospital of Dayi County (Approval number: 1002-084). In all, 50 patients with lumbar vertebral osteomyelitis (LVO) who prepares surgical treatment will be included in the study. We contain adult patients (aged over 18 years) who accept debridement and spinal stabilization with LVO. Cases are removed if there is previous hardware placement, cases who are not confirmed by microbiology, or severe renal and liver dysfunction. The primary outcomes are intraoperative blood loss, operative time, hospital stay, primary failure and recurrence, and bone fusion. The secondary outcomes are postoperative pain score and physical recovery. SPSS Sample Power version 3.0 (IBM, Armonk, NY, USA) is used for data analysis. Table 1 will show the outcomes in both groups. This protocol may offer a reliable basis for the effectiveness of the two approaches in the treatment of PVO. researchregistry6046.
Sections du résumé
BACKGROUND
BACKGROUND
Pyogenic osteomyelitis of the spine usually occurs in patients over 55 years old with acute osteomyelitis. Surgical treatment and fixation can relieve pain, enhance spinal balance and nerve function, so that patients can walk as soon as possible. Different outcomes of surgical methods include anterior minimally invasive oblique retroperitoneal approach (ORA) and posterior transpedicular approach (PTA). While, there is no consensus on the best treatment for PVO. The goal of the protocol is to compare the clinical consequences between PTA and ORA for treating PVO.
METHOD
METHODS
The experiment is a single-center randomized clinical research. This experiment was admitted by the Ethics Committee of the People's Hospital of Dayi County (Approval number: 1002-084). In all, 50 patients with lumbar vertebral osteomyelitis (LVO) who prepares surgical treatment will be included in the study. We contain adult patients (aged over 18 years) who accept debridement and spinal stabilization with LVO. Cases are removed if there is previous hardware placement, cases who are not confirmed by microbiology, or severe renal and liver dysfunction. The primary outcomes are intraoperative blood loss, operative time, hospital stay, primary failure and recurrence, and bone fusion. The secondary outcomes are postoperative pain score and physical recovery. SPSS Sample Power version 3.0 (IBM, Armonk, NY, USA) is used for data analysis.
RESULTS
RESULTS
Table 1 will show the outcomes in both groups.
CONCLUSION
CONCLUSIONS
This protocol may offer a reliable basis for the effectiveness of the two approaches in the treatment of PVO.
TRIAL REGISTRATION NUMBER
BACKGROUND
researchregistry6046.
Identifiants
pubmed: 33126375
doi: 10.1097/MD.0000000000022990
pii: 00005792-202010300-00079
pmc: PMC7598824
doi:
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e22990Références
Neurosurg Rev. 2018 Jan;41(1):355-363
pubmed: 29090359
Kurume Med J. 2019 Sep 25;65(3):83-89
pubmed: 31406038
Br J Surg. 1960 Sep;48:172-8
pubmed: 13714863
J Hosp Infect. 2012 Sep;82(1):40-8
pubmed: 22738613
Spine J. 2019 May;19(5):880-887
pubmed: 30500465
J Neurosurg Spine. 2019 Jan 4;30(3):405-413
pubmed: 30611150
Curr Rev Musculoskelet Med. 2019 Jun 22;:305-310
pubmed: 31230190
Clin Microbiol Infect. 2014 Oct;20(10):1055-60
pubmed: 24766063
Br Med Bull. 2016 Mar;117(1):121-38
pubmed: 26872859
World Neurosurg. 2018 Sep;117:e22-e33
pubmed: 29787879
Eur Spine J. 2007 Sep;16(9):1307-16
pubmed: 17106664
Asian Spine J. 2017 Aug;11(4):618-626
pubmed: 28874981
Epidemiol Infect. 2008 May;136(5):653-60
pubmed: 17568478
Ann Transl Med. 2018 Mar;6(6):104
pubmed: 29707553
J Bone Joint Surg Br. 2008 Nov;90(11):1477-81
pubmed: 18978269
Clin Orthop Relat Res. 2014 Jun;472(6):1855-67
pubmed: 24474323
Eur Rev Med Pharmacol Sci. 2012 Apr;16 Suppl 2:35-49
pubmed: 22655482