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The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial.

ABSTRACT: Vitamin C has critical features relavant to postoperative pain management and functional improvement; however, no study has yet evaluated the effectiveness of vitamin C on improving the surgical outcomes for spine pathologies. Thus, this study aimed to explore the impact of vitamin C on postoperative outcomes after single-level posterior lumbar interbody fusion (PLIF) for lumbar spinal stenosis in prospectively randomized design. We conducted a 1-year prospective, randomized, placebo-controlled, double-blind study to evaluate the impact of vitamin C on the postoperative outcomes after PLIF surgery.A total of 123 eligible patients were randomly assigned to either group A (62 patients with vitamin C) or group B (61 patients with placebo). Patient follow-up was continued for at least 1 year after surgery. The primary outcome measure was pain intensity in the lower back using a visual analogue scale. The secondary outcome measures were: (1) the clinical outcome assessed using the Oswestry Disability Index (ODI); (2) the fusion rate assessed using dynamic radiographs and computed tomography scans; and (3) complications.Pain intensity in the lower back was significantly improved in both groups compared with preoperative pain intensity, but no significant difference was observed between the 2 groups over the follow-up period. The ODI score of group A at the third postoperative month was significantly higher than the score of group B. After the sixth postoperative month, the ODI score of group A was slightly higher than the score of group B; however, this difference was not significant. The fusion rates at 1 year after surgery and the complication rates were not significantly different between the 2 groups.Postoperative pain intensity, the primary outcome measure, was not significantly different at 1 year after surgery between the 2 groups. However, vitamin C may be associated with improving functional status after PLIF surgery, especially during the first 3 postoperative months.

SUBMITTER: Lee GW

PROVIDER: S-EPMC5567027 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial.

Lee Gun Woo GW Yang Han Seok HS Yeom Jin S JS Ahn Myun-Whan MW

Clinics in orthopedic surgery 20170804 3

<h4>Background</h4>Vitamin C has critical features relavant to postoperative pain management and functional improvement; however, no study has yet evaluated the effectiveness of vitamin C on improving the surgical outcomes for spine pathologies. Thus, this study aimed to explore the impact of vitamin C on postoperative outcomes after single-level posterior lumbar interbody fusion (PLIF) for lumbar spinal stenosis in prospectively randomized design. We conducted a 1-year prospective, randomized, ...[more]

PMID: 28861199

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Project description:BackgroundControversy exists regarding the ability of posterior (transforaminal) lumbar interbody fusion (PLIF/TLIF) to achieve lordosis. We hypothesized that an interbody device (IBD) designed for positioning in the anterior disc space produces greater lordosis than IBDs designed for straight-in positioning. The purpose of this study is to determine if using either an anterior-position or straight-in position IBD design were associated with successful achievement of postoperative lordosis.MethodsA consecutive series of patients undergoing a undergoing a single-level, posterior open midline (transforaminal) lumbar interbody fusion procedure for degenerative spine conditions during a time period when the two types of interbody devices were being used at surgeon discretion were identified from a multi-surgeon academic training center. Patient demographics and radiographic measures including surgical level lordosis (SLL), anterior disc height, middle disc height, posterior disc height, IBD height, and IBD insertion depth were measured on preop, immediate postop, and one-year postop standing radiographs using PACS. Group comparison and regression analysis were performed using SPSS.ResultsSixty-one patients were included (n=37 anterior, n=34 straight-in). Mean age was 59.8±8.7 years, 32 (52%) were female. There was no difference between IBD type (anterior vs. straight-in) for mean Pre-op SLL (19±7° vs. 20±6°, p=0.7), Post-op SLL (21±5° vs 21±6°, p=0.5), or Change in SLL (2±4° vs. 1±5°, p=0.2). Regression analysis showed that Pre-op SLL was the only variable associated with Change in SLL (Beta = negative 0.48, p=0.000). While the mean Change in SLL could be considered clinically insignificant, there was wide variability: from a loss of 9° to a gain of 13°. Gain of lordosis >5° only occurred when Pre-op SLL was <21°, and loss of lordosis >5° only occurred when Pre-op SLL was >21°.ConclusionsWhile group averages showed an insignificant change in segmental lordosis following a posterior (transforaminal) interbody fusion regardless of interbody device type, pre-operative lordosis was correlated with a clinically significant change in segmental lordosis. Preoperative hypolordotic discs were more likely to gain significant lordosis, while preoperative hyperlordotic discs were more likely to lose significant lordosis. Surgeon awareness of this tendency can help guide surgical planning and technique.

Project description:IntroductionThe demand for spinal fusion surgery has increased over the last decades. Health care providers should take costs and cost-effectiveness of these surgeries into account. Open transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are two widely used techniques for spinal fusion. Earlier research revealed that TLIF is associated with less blood loss, shorter surgical time and sometimes shorter length of hospital stay, while effectiveness of both techniques on back and/or leg pain are equal. Therefore, TLIF could result in lower costs and be more cost-effective than PLIF. This is the first systematic review comparing direct and indirect (partial) economic evaluations of TLIF with PLIF in adults with lumbar spondylolisthesis. Furthermore, methodological quality of included studies was assessed.MethodsSearches were conducted in eight databases for reporting on eligibility criteria; TLIF or PLIF, lumbar spondylolisthesis or lumbar instability, and cost. Costs were converted to United States Dollars with reference year 2020. Study quality was assessed using the bias assessment tool of the Cochrane Handbook for Systematic Reviews of Interventions, the Level of Evidence guidelines of the Oxford Centre for Evidence-based Medicine and the Consensus Health Economic Criteria (CHEC) list.ResultsOf a total of 693 studies, 16 studies were included. Comparison of TLIF and PLIF could only be made indirectly, since no study compared TLIF and PLIF directly. There was a large heterogeneity in health care and societal perspective costs due to different in-, and exclusion criteria, baseline characteristics and the use of costs or charges in calculations. Health care perspective costs, calculated with hospital costs, ranged from $15,867-$43,217 in TLIF-studies and $32,662 in one PLIF-study. Calculated with hospital charges, it ranged from $8,964-$51,469 in TLIF-studies and $21,838-$93,609 in two PLIF-studies. Societal perspective costs and cost-effectiveness, only mentioned in TLIF-studies, ranged from $5,702/QALY-$48,538/QALY and $50,092/QALY-$90,977/QALY, respectively. Overall quality of studies was low.ConclusionsThis systematic review shows that TLIF and PLIF are expensive techniques. Moreover, firm conclusions about the preferable technique, based on (partial) economic evaluations, cannot be drawn due to limited studies and heterogeneity. Randomized prospective trials and full economical evaluations with direct TLIF and PLIF comparison are needed to obtain high levels of evidence. Furthermore, development of guidelines to perform adequate economic evaluations, specified for the field of interest, will be useful to minimize heterogeneity and maximize transferability of results.Trial registrationProspero-database registration number: CRD42020196869.

Dataset Information

The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial.

Publications

The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial.

Similar Datasets

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