Dataset Information

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.

ABSTRACT: 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?

SUBMITTER: Lehr AM

PROVIDER: S-EPMC7515483 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.

Lehr A Mechteld AM Oner F Cumhur FC Delawi Diyar D Stellato Rebecca K RK Hoebink Eric A EA Kempen Diederik H R DHR van Susante Job L C JLC Castelein René M RM Kruyt Moyo C MC

Spine 20201001 20

<h4>Study design</h4>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.<h4>Objectives</h4>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.<h4>Summary of backgr ...[more]

PMID: 32459724

Similar Datasets

Project description:Study designin the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial.ObjectiveThe aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF).Summary of background dataSpinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited.MethodsThis study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI).ResultsThere were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%).ConclusionThe results of this noninferiority trial support the use of AttraX Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF.Level of evidence1.

Project description:Background contextPseudarthrosis following spinal fusion remains problematic despite modern surgical and grafting techniques. In surgical spinal fusion, new bone forms via intramembranous and endochondral ossification, with endochondral ossification occurring in the hypoxic zones of the fusion bed. During bone development and fracture healing, the key cellular mediator of endochondral ossification is the hypertrophic chondrocyte given its ability to function in hypoxia and induce neovascularization and ossification. We therefore hypothesize that hypertrophic chondrocytes may be an effective bone graft alternative.PurposeSpinal fusion procedures have increased substantially; yet 5% to 35% of all spinal fusions may result in pseudoarthrosis. Pseudoarthrosis may occur because of implant failure, infection, or biological failure, among other reasons. Advances in surgical techniques and bone grafting have improved fusion; however pseudarthrosis rates remain unacceptably high. Thus, the goal of this study is to investigate hypertrophic chondrocytes as a potential biological graft alternative.MethodsUsing a validated murine fracture model, hypertrophic chondrocytes were harvested from fracture calluses and transplanted into the posterolateral spines of identical mice. New bone formation was assessed by X-ray, microcomputed tomography (μCT), and in vivo fluorescent imaging. Results were compared against a standard iliac crest bone graft and a sham surgery control group. Funding for this work was provided by the Department of Orthopaedics and Rehabilitation, the OREF (Grant #16-150), and The Caitlin Lovejoy Fund.ResultsRadiography, μCT, and in vivo fluorescent imaging demonstrated that hypertrophic chondrocytes promoted bone formation at rates equivalent to iliac crest autograft. Additionally, μCT analysis demonstrated similar fusion rates in a subset of mice from the iliac crest and hypertrophic chondrocyte groups.ConclusionsThis proof-of-concept study indicates that hypertrophic chondrocytes can promote bone formation comparable to iliac crest bone graft. These findings provide the foundation for future studies to investigate the potential therapeutic use of hypertrophic chondrocytes in spinal fusion.

Dataset Information

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.

Publications

Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets