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MagnetOs Clinical Evidence

Biphasic calcium phosphate bone graft with a unique surface topography: A single-center ambispective study for degenerative disease of the lumbar spine

Study design: This study is an ambispective evaluation and analysis of a single-center cohort.

Objective: This study aimed to evaluate the performance of a novel biphasic calcium phosphate (BCP) bone graft with submicron-sized needle-shaped surface topography (BCP<µm) in interbody arthrodesis of the lumbar spine.*

Methods: This study was a single-center ambispective assessment of adult patients receiving BCP<µm as part of their lumbar interbody fusion surgery. The primary outcome was a fusion status on computed tomography (CT) 12 months postoperative. The secondary outcomes included postoperative changes in the visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form 12 (SF-12), and length of stay (LOS).

Results: Sixty-three patients with one- to three-level anterior (48, 76%) and lateral (15, 24%) interbody fusions with posterior instrumentation were analyzed. Thirty-one participants (49%) had three or more comorbidities, including heart disease (43 participants, 68%), obesity (31 participants, 49%), and previous lumbar surgery (23 participants, 37%). The mean ODI decreased by 24. The mean SF-12 physical health and SF-12 mental health improved by a mean of 11.5 and 6.3, respectively. The mean VAS for the left leg, right leg, and back improved by a mean of 25.75, 22.07, and 37.87, respectively. Of 101 levels, 91 (90%) demonstrated complete bridging trabecular bone fusion with no evidence of supplemental fixation failure.

Conclusion: The data of BCP<µm in interbody fusions for degenerative disease of the lumbar spine provides evidence of fusion in a complicated cohort of patients.

Citation: Nunley P, Sanda M, Googe H, et al. (April 13, 2024) Biphasic Calcium Phosphate Bone Graft With a Unique Surface Topography: A Single-Center Ambispective Study for Degenerative Disease of the Lumbar Spine. Cureus 16(4): e58218. DOI 10.7759/cureus.58218

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 MagnetOs is not cleared by the FDA as an osteoinductive bone graft.

*When used in intervertebral body fusion procedures, BCP<µm Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.