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Favorable preliminary results of MagnetOs as standalone alternative to autograft in a prospective, multi-center, randomized, intra-patient controlled trial
Objective: This multicenter trial was initiated to determine non-inferiority of a BCP with submicron-sized needleshaped surface features, MagnetOs Granules, as compared to autograft in instrumented posterolateral spinal fusion. This is the interim analysis for the safety and fusion rate of the first 50 subjects that were enrolled.
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). In obtaining the cortico-cancellous bone from the iliac wing, only one side was harvested, unless that side was inappropriate due to previous harvesting or anatomical reasons. If possible, harvesting was done via the same posterior incision for spinal fusion. In case of an additional interbody fusion procedure, the cage was preferably filled with local autograft bone and positioned before opening of the randomization envelope. If the surgeon decided to use iliac crest bone for the cage, the cage was only inserted after the randomization and related harvesting side had been disclosed. 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.
Conclusion: This interim analysis found a 78% fusion rate of MagnetOs Granules by subject, and a 76.1% fusion rate of MagnetOs Granules by level. The results of this ongoing, prospective study aiming to determine the non-inferiority of MagnetOs Granules used standalone as compared to autograft are promising. Ongoing studies with more subjects are forthcoming.
Disclaimer: Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. Please refer to the Instructions for Use for a full list of indications, contraindications, precautions and warnings. For important safety and intended use information please visit kurosbio.com. MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.