ArticleInternational journal of spine surgery2024
High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.
Article in International journal of spine surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02969616 (A Prospective, Post Market, Multi-center, Open Label, Non-Randomized Clinical Study of the Efficacy of Using Trinity ELITE in Lumbar Fusion Surgery), which is not on this map. Not yet cited in PubMed.
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A Prospective, Post Market, Multi-center, Open Label, Non-Randomized Clinical Study of the Efficacy of Using Trinity ELITE in Lumbar Fusion Surgery
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10 authors.
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Abstract
backgroundMounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches).
methodsPatients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis.
resultsA total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m
conclusionsCBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. CLINICAL RELEVANCE: The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. LEVEL OF EVIDENCE: 4:
trial registrationNCT02969616.
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