Authors: Riccardo Sinigaglia Albert Bundy Sandro Costantini Ugo Nena Francesco Finocchiaro Daniele A Fabris Monterumici
Publish Date: 2009/04/29
Volume: 18, Issue: 1, Pages: 52-63
Abstract
The aim of our prospective nonrandomized clinical study was to analyze operative data shortterm results safety efficacy complications and prognostic factors for singlelevel total lumbar disc replacement TLDR and to compare results between different levels L4–L5 vs L5–S1 Thirtysix patients with singlelevel L4–L5 or L5–S1 TLDR with 1year minimum followup FU had complete clinical SF36 visual analog scale VAS Oswestry Disability Index ODI and radiological data and were included in our study Mean FU was 3867 ± 1734 months Replaced level was L4–L5 in 12 333 cases and L5–S1 in 24 cases 667 Mean age at diagnosis was 4117 ± 714 years 24 667 were females and 12 333 were males Statistical analyses were assessed using t tests or Mann–Whitney test for continuous variables and Chisquare test or Fisher’s exact test analyses for categorical variables Univariate linear regression and binary logistic regression analyses were utilized to evaluate the relationship between surgical outcomes and covariates gender age etiology treated level preoperative SF36 ODI and VAS Mean operative time was 14703 ± 3003 min Mean hospital stay was 969 ± 539 days and mean return to ambulation was 431 ± 117 days At 1year FU patients revealed a statistical significant improvement in VAS pain P = 0000 ODI lumbar function P = 0000 and SF36 general health status P = 0000 Singlelevel TLDR is a good alternative to fusion for chronic discogenic low back pain refractory to conservative measures Our study confirmed satisfactory clinical results for monosegmental L4–L5 and L5–S1 disc prosthesis with no difference between the two different levels for SF36 P = 0217 ODI P = 0527 and VAS P = 0269 However replacement of the L4–L5 disc is affected by an increased risk of complication P = 0000 There were no prognostic factors for intraoperative blood loss or return to ambulation Age P = 0034 was the only prognostic factor for operative time Hospital stay was affected by level P = 0036 and preop VAS P = 0006 while complications were affected by the level P = 0000 and preop ODI P = 0049 Complete preoperative assessment in particular VAS and ODI questionnaires is important because more debilitating patients will have more hospital stay and higher complications or complaints Patients had to be informed that complications possibly severe are particularly frequent 806
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