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Comparison of Silicate-Substituted Calcium Phosphate (Actifuse) with Recombinant Human Bone Morphogenetic Protein-2 (Infuse) in Posterolateral Instrumented Lumbar Fusion.

ABSTRACT: Study Design Randomized controlled trial. Objective The aim of this study was to assess the efficacy of the bone grafting substitute silicate-substituted calcium phosphate (SiCaP) compared with recombinant human bone morphogenetic protein 2 (rhBMP-2) and to evaluate the clinical outcomes over a period of 2 years. Methods Patients undergoing PLF surgery for DDD at a single center were recruited and randomized to one of two groups: SiCaP (n = 9) or rhBMP-2 (n = 10). One patient withdrew prior to randomization and another from the rhBMP-2 group after randomization. The radiologic and clinical outcomes were examined and compared. Fusion was assessed at 12 months with computed tomography and plain radiographs. Clinical outcomes were evaluated by recording measures of pain, quality of life, disability, and neurologic status from 6 weeks to 2 years postoperatively. Results In the SiCaP and rhBMP-2 groups, fusion was observed in 9/9 and 8/9 patients, respectively. Pain and disability scores were reduced and quality of life increased in both groups. Leg pain, disability, and satisfaction scores were similar between the groups at each postoperative point; however, back pain was less at 6 weeks and quality of life was higher at 6 months in the SiCaP group than the rhBMP-2 group. Conclusions SiCaP and rhBMP-2 were comparable in terms of achieving successful bone growth and fusion. Both groups achieved similar alleviation of pain and improved quality of life and neurologic, satisfaction, and return to work outcomes following PLF surgery.

SUBMITTER: Licina P

PROVIDER: S-EPMC4671893 | biostudies-other | 2015 Dec

REPOSITORIES: biostudies-other

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Project description:STUDY DESIGN:Two-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX Putty) with autograft in instrumented posterolateral fusion (PLF) surgery. OBJECTIVES:The aim of this study was to compare PLF rates between 1 and 2 years of follow-up and between graft types, and to explore the role of bone grafting based on the location of the PLF mass. SUMMARY OF BACKGROUND DATA:There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting. METHODS:A total of 100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1-year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment was blindly assessed on CT scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (P?<?0.05). RESULTS:The 2-year PLF rate (66 patients) was 70% at the AttraX Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE analysis demonstrated a significant increase for both conditions (odds ratio 2.0, 95% confidence interval 1.5-2.7, P?<?0.001), but no difference between the grafts (P?=?0.595). Ongoing bone formation was only observed between the facet joints. CONCLUSION:This intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting. LEVEL OF EVIDENCE:1.

Project description:BackgroundSmoking cessation represents an opportunity to reduce both short and long-term effects of smoking on complications after lumbar fusion and smoking-related morbidity and mortality. However, the cost-effectiveness of smoking-cessation interventions prior to lumbar fusion is not fully known.MethodsWe created a decision-analytic Markov model to evaluate the cost-effectiveness of 5 smoking-cessation strategies (behavioral counseling, nicotine replacement therapy [NRT], bupropion or varenicline monotherapy, and a combined intervention) prior to single-level, instrumented lumbar posterolateral fusion (PLF) from the health payer perspective. Probabilities, costs, and utilities were obtained from published sources. We calculated the costs and quality-adjusted life years (QALYs) associated with each strategy over multiple time horizons and accounted for uncertainty with probabilistic sensitivity analyses (PSAs) consisting of 10,000 second-order Monte Carlo simulations.ResultsEvery smoking-cessation intervention was more effective and less costly than usual care at the lifetime horizon. In the short term, behavioral counseling, NRT, varenicline monotherapy, and the combined intervention were also cost-saving, while bupropion monotherapy was more effective but more costly than usual care. The mean lifetime cost savings for behavioral counseling, NRT, bupropion monotherapy, varenicline monotherapy, and the combined intervention were $3,291 (standard deviation [SD], $868), $2,571 (SD, $479), $2,851 (SD, $830), $6,767 (SD, $1,604), and $34,923 (SD, $4,248), respectively. The minimum efficacy threshold (relative risk for smoking cessation) for lifetime cost savings varied from 1.01 (behavioral counseling) to 1.15 (varenicline monotherapy). A PSA revealed that the combined smoking-cessation intervention was always more effective and less costly than usual care.ConclusionsEven brief smoking-cessation interventions yield large short-term and long-term cost savings. Smoking-cessation interventions prior to PLF can both reduce costs and improve patient outcomes as health payers/systems shift toward value-based reimbursement (e.g., bundled payments) or population health models.Level of evidenceEconomic Level II. See Instructions for Authors for a complete description of levels of evidence.

Project description:Study Design Randomized controlled trial. Objective Despite a large number of publications of outcomes after spinal fusion surgery, there is still no consensus on the efficacy of the several different fusion methods. The aim of this study was to determine whether transforaminal lumbar interbody fusion (TLIF) results in an improved clinical outcome compared with uninstrumented posterolateral fusion (PLF) in the surgical treatment for chronic low back pain. Methods This study included 135 patients with degenerative disk disease (n = 96) or postdiskectomy syndrome (n = 39). Inclusion criteria were at least 1 year of back pain with or without leg pain in patients aged 20 to 65 with one- or two-level disease. Exclusion criteria were sequestration of disk hernia, psychosocial instability, isthmic spondylolisthesis, drug abuse, and previous spine surgery other than diskectomy. Pain was assessed by visual analog scale (pain index). Functional disability was quantified by the disability rating index and Oswestry Disability Index. The global outcome was assessed by the patient and classified as much better, better, unchanged, or worse. The patients were randomized to conventional uninstrumented PLF (n = 67) or TLIF (n = 68). PLF was performed in a standardized fashion using autograft. TLIF was performed with pedicle titanium screw fixation and a porous tantalum interbody spacer with interbody and posterolateral autograft. The clinical outcome measurements were obtained preoperatively and at 12 and 24 months postoperatively. The 2-year follow-up rate was 98%. Results The two treatment groups improved significantly from preoperatively to 2 years' follow-up. At final follow-up, the results in the TLIF group were significantly superior to those in the PLF group in pain index (2.0 versus 3.9, p = 0.007) and in disability rating index (22 versus 36, p = 0.003). The Oswestry Disability Index was better in the TLIF group (20 versus 28, p = 0.110, not significant). The global assessment was clearly superior in the TLIF group: 63% of patients scored "much better" in the TLIF group as compared with 48% in the PLF group (p = 0.017). Conclusions The results of the current study support the use of TLIF rather than uninstrumented PLF in the surgical treatment of the degenerative lumbar spine. The less optimal outcome after uninstrumented PLF may be explained by the much higher reoperation rate.

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Comparison of Silicate-Substituted Calcium Phosphate (Actifuse) with Recombinant Human Bone Morphogenetic Protein-2 (Infuse) in Posterolateral Instrumented Lumbar Fusion.

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