RESUMO
BACKGROUND: Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs. STUDY DESIGN: This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database. METHODS: The database was queried from its inception to November 2022 for reports associated with "Prosthesis, Spinous Process Spacer/Plate." Entries were categorized by event type, patient impact, and interventions. RESULTS: A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, n = 374) and fractures (2.2%, n = 21). The most common postoperative events were persistent pain (26.6%, n = 251), implant migration (19.1%, n = 180), and fracture (6.8%, n = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, n = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications. CONCLUSIONS: The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants. CLINICAL RELEVANCE: Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery.
RESUMO
BACKGROUND CONTEXT: Navigation and robotic technologies have emerged as an alternative option to conventional freehand techniques for pedicle screw insertion. However, the effectiveness of these technologies in reducing the perioperative complications of spinal fusion surgery remains limited due to the small cohort size in the existing literature. PURPOSE: To investigate whether utilization of robotically navigated pedicle screw insertion can reduce the perioperative complications of spinal fusion surgery-including reoperations-with a sizeable cohort. STUDY DESIGN: Retrospective study. PATIENT SAMPLE: Patients who underwent primary lumbar fusion surgery between 2019 and 2022. OUTCOME MEASURES: Perioperative complications including readmission, reoperation, its reasons, estimated blood loss, operative time, and length of hospital stay. METHODS: Patients' data were collected including age, sex, race, body mass index, upper-instrumented vertebra, lower-instrumented vertebra, number of screws inserted, and primary procedure name. Patients were classified into the following two groups: freehand group and robot group. The variable-ratio greedy matching was utilized to create the matched cohorts by propensity score and compared the outcomes between the two group. RESULTS: A total of 1,633 patients who underwent primary instrumented spinal lumbar fusion surgery were initially identified (freehand 1,286; robot 347). After variable ratio matching was performed with age, sex, body mass index, fused levels, and upper instrumented vertebrae level, 694 patients in the freehand group and 347 patients in robot groups were selected. The robot group showed less estimated blood loss (418.9±398.9 vs 199.2±239.6 ml; p<.001), shorter LOS (4.1±3.1 vs 3.2±3.0 days; p<.001) and similar operative time (212.5 vs 222.0 minutes; p=.151). Otherwise, there was no significant difference in readmission rate (3.6% vs 2.6%; p=.498), reoperation rate (3.2% vs 2.6%; p=.498), and screw malposition requiring reoperation (five cases, 0.7% vs one case, 0.3%; p=1.000). CONCLUSIONS: Perioperative complications requiring readmission and reoperation were similar between fluoroscopy guided freehand and robotic surgery. Robot-guided pedicle screw insertion can enhance surgical efficiency by reducing intraoperative blood loss and length of hospital stay without extending operative time.