ArticleInternational journal of spine surgery2025
Spinopelvic Fixation Using an Osseointegrative Implant: Analysis of Postmarket Surveillance to Determine the Failure Rate.
Article in International journal of spine surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Removal of spinopelvic S2 alar-iliac osseointegrative screws: a case report and surgical technique guide.Journal of spine surgery (Hong Kong) · 2026Article
- Stabilization of L5 pedicle Subtraction osteotomies (PSO) with ≥ 6-rods and bilateral dual pelvic fixation with osseointegrative implants: surgical technique description and early postoperative outcomes.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025Article
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdult spinal deformities, affecting up to 60% of individuals older than 60 years, often require long segment fusions. Constructs spanning the lumbosacral junction commonly include pelvic fixation. Despite robust pelvic fixation, distal junctional failure, such as pseudoarthrosis, bone fracture, and instrumentation failure, occurs in 24%-34% of these cases. A novel implant designed for both durable pelvic fixation and sacroiliac joint fusion was recently cleared by the US Food and Drug Administration. This implant is engineered to address some of the pelvic fixation failure mechanisms by reducing motion at the lumbosacral junction and sacroiliac joint while decreasing stress on S1 pedicle screws and S2AI implants.
objectiveTo determine the failure rate of a novel osseointegrative implant for spinopelvic fixation/fusion. STUDY
designAnalysis of manufacturer postmarket surveillance database.
methodsA postmarket surveillance database was analyzed to determine the type and rate of complaints and revisions of a novel osseointegrative implant. These were then compared with the published literature.
resultsA total of 15,628 implants were identified in 6907 patients. The postmarket surveillance of the novel screw fusion device revealed a low complaint rate of 0.75% and no postoperative implant breakage. Revision procedures were mostly due to set screw dissociation (0.4%) and implant loosening (0.15%), which was primarily linked to pre-existing conditions or infection. The mean (SD) time from index procedure to the complaint was 7.1 (5.4) months.
conclusionsCompared with published literature, this novel osseointegrative implant demonstrates a significantly lower incidence of set screw dissociation than traditional pelvic screws with no incidence of breakage or back out, underscoring its durable integration with bone, with low rates of revisions and mechanical failures. CLINICAL RELEVANCE: A novel osseointegrative implant offers reduced rates of mechanical failures and revisions, helping to reduce complications in pelvic fixation procedures. LEVEL OF EVIDENCE: 4:
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