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A randomized, intra-patient controlled trial of MagnetOs Granules versus autograft in instrumented posterolateral spinal fusion (MAXA)
Objective: This multicenter trial was initiated to determine non-inferiority of MagnetOs Granules used standalone as compared to autograft in instrumented posterolateral spinal fusion.
Methods: This multicenter study was initiated and coordinated by five participating academic centers (Medical Ethics Review Committee number 18-311; Assessment and Registration ABR number NL64652.041.18). Adult subjects qualifying for instrumented posterolateral spinal fusion of one to six levels in the thoracolumbar and lumbosacral region from T10 to S2 were indicated for the analysis. Informed consent was obtained. In all cases, according to study protocol, a standard surgical technique was used for a posterolateral spine approach. After instrumentation and preparation of the bone bed, the randomized side of the graft was disclosed to the surgeon. In all subjects at all levels, one side (right or left) was grafted with 10cc of autograft per level. The autograft was a combination of local vertebral bone supplemented with at least 50% cortico-cancellous bone harvested from the iliac crest. The other randomized side was grafted with 10cc of MagnetOs Granules without added autograft or bone marrow aspirate (standalone bone graft). All subjects were evaluated radiologically and clinically at several time points pre- and post-operatively, and all serious adverse events related to the procedure were documented. Prospective follow-up included adverse events, the Oswestry Disability Index (ODI), and a fine-cut (<1mm) Computerized Tomography (CT) at one year. Fusion was systematically scored as “fusion” or “no fusion” per level per side by two spine surgeons blinded for the procedure per the following protocol: both left and right were “no fusion” if none of the levels were fused, both sides were “fusion” if an equal number of levels were fused per side, or “fusion” on one side and “no fusion” on the other side if one side contained more levels with “fusion” than the other side. Disagreements were resolved by panel discussion.
Results: Initial analysis of 91 patients (128 levels) reported a MagnetOs Granules fusion rate of 79% (101/128 levels) and an autograft fusion rate of 47% (60/128 levels). Furthermore, MagnetOs Granules showed an 80% fusion rate in a smoking population compared to 32% for the autograft group.
Conclusion: Initial results have not yet been statistically analyzed or peer reviewed. However, interim analysis and the initial fusion data of this prospective study comparing MagnetOs Granules to autograft are promising. Final data are forthcoming.
Disclaimers: Publication of the final data is expected in 2024 and will include advanced statistical analyses, interbody data, adverse advents, and patient reported outcome measures. The attached whitepaper describes the promising interim data analysis of the first 50 patients comparing MagnetOs Granules to autograft in the intra-patient controlled study.
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