Infections in spinal instrumentation.

Surgical-site infection (SSI) in the spine is a serious postoperative complication. Factors such as posterior surgical approach, arthrodesis, use of spinal instrumentation, age, obesity, diabetes, tobacco use, operating-room environment and estimated blood loss are well established in the literature to affect the risk of infection. Infection after spine surgery with instrumentation is becoming a common pathology. The reported infection rates range from 0.7% to 11.9%, depending on the diagnosis and complexity of the procedure. Besides operative factors, patient characteristics could also account for increased infection rates. These infections after instrumented spinal fusion are particularly difficult to manage due to the implanted, and possibly infected, instrumentation. Because the medical, economic and social costs of SSI after spinal instrumentation are enormous, any significant reduction in risks will pay dividends. The goal of this literature review was to analyse risk factors, causative organisms, diagnostic elements (both clinical and biological), different treatment options and their efficiency and consequences and the means of SSI prevention.

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.

BACKGROUND CONTEXT: The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date. PURPOSE: The purpose of this study was to compare the safety and effectiveness at the five-year follow-up time point of lumbar total disc replacement using the CHARITE artificial disc (DePuy Spine, Raynham, MA) with that of anterior lumbar interbody fusion (ALIF) with BAK cages and iliac crest autograft, for the treatment of single-level degenerative disc disease from L4 to S1, unresponsive to nonoperative treatment. STUDY DESIGN/SETTING: Randomized controlled trial-five-year follow-up. PATIENT SAMPLE: Ninety CHARITE patients and 43 BAK patients. OUTCOME MEASURES: Self-reported measures: visual analog scale (VAS); validated Oswestry disability index (ODI version 1.0); Short-Form 36 Questionnaire, and patient satisfaction. Physiologic measures: radiographic range of motion, disc height, and segmental translation. Functional measures: work status. METHODS: Of the 375 subjects enrolled in the CHARITE IDE trial, 277 were eligible for the five-year study and 160 patients thereof completed the five-year follow-up. The completers included 133 randomized patients. Overall success was defined as improvement> or =15 pts in ODI vs. baseline, no device failure, absence of major complications, and maintenance or improvement of neurological status. Additional clinical outcomes included an ODI questionnaire as well as VAS, SF-36, and patient satisfaction surveys. Work status was tracked for all patients. Safety assessments included occurrence and severity of adverse events and device failures. Radiographic analyses such as index- and adjacent-level range of motion, segmental translation, disc height, and longitudinal ossification were also carried out. RESULTS: Overall success was 57.8% in the CHARITE group vs. 51.2% in the BAK group (Blackwelder's test: p=0.0359, Delta=0.10). In addition, mean changes from baseline for ODI (CHARITE: -24.0 pts vs. BAK: -27.5 pts), VAS pain scores (CHARITE: -38.7 vs. BAK: -40.0), and SF-36 questionnaires (SF-36 Physical Component Scores [PCS]: CHARITE: 12.6 pts vs. BAK: 12.3 pts) were similar across groups. In patient satisfaction surveys, 78% of CHARITE patients were satisfied vs. 72% of BAK patients. A total of 65.6% patients in the CHARITE group vs. 46.5% patients in the BAK group were employed full-time. This difference was statistically significant (p=0.0403). Long-term disability was recorded for 8.0% of CHARITE patients and 20.9% of BAK patients, a difference that was also statistically significant (p=0.0441). Additional index-level surgery was performed in 7.7% of CHARITE patients and 16.3% of BAK patients. Radiographic findings included operative and adjacent-level range of motion (ROM), intervertebral disc height and segmental translation. At the five-year follow-up, the mean ROM at the index level was 6.0 degrees for CHARITE patients and 1.0 degrees for BAK patients. Changes in disc height were also similar for both CHARITE and BAK patients (0.7 mm for both groups, p=0.9827). Segmental translation was 0.4 and 0.8mm in patients implanted with CHARITE at L4-L5 vs. L5-S1, respectively, and 0.1mm in BAK patients. CONCLUSIONS: The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.

Blood conservation techniques in spinal deformity surgery: a retrospective review of patients refusing blood transfusion.

STUDY DESIGN: A retrospective review. OBJECTIVE: To review the effectiveness of blood conservation techniques in the spinal fusion of patients that refuse blood transfusion; specifically the Jehovah's witnesses population. SUMMARY OF BACKGROUND: Spinal surgery can be challenging in patients refusing blood transfusion. There is paucity in the literature examining blood conservation techniques in spinal surgery. METHODS: The radiographic and medical records of 19 Jehovah's witnesses patients who underwent spinal deformity surgery at a single institution between 2000 and 2003 were reviewed. Patients were assessed for excessive blood loss (EBL), deformity correction, operative time, perioperative complications, and hospital stay. At latest follow-up (mean, 40 months; range, 8-76) the patients were examined for radiographic fusion, progression and complications. RESULTS: Spinal fusion was attempted in 19 patients, with a mean age of 17 years (range, 10-36 years). All 19 patients were identified through the "Bloodless Surgery Program." Hypotensive anesthesia, hemodilution, and cell saver was employed for all 19 cases. Erythropoietin with supplemental iron was used in 15 patients. Aprotinin was used in 3 patients. EBL and blood returned by cell saver averaged 855 and 341 mL, respectively. Operative times average 315 minutes. The average drop in hemoglobin from after surgery was 3.1 g/dL. There were 2 intraoperative complications: (i) transient loss of somatosensory evoked potential/motor evoked potential signals; and (ii) one surgery abandoned due to EBL. The average spinal deformity correction was 58%. There were 3 postoperative complications, none related to their refusal of a transfusion. 17 patients were available for radiographic and clinic follow-up of at least 24 months. All displayed radiographic fusion without progression. CONCLUSION: These blood conservation techniques allow satisfactory completion of deformity surgery on those patients not willing to be transfused and without major anesthetic or medical complications.

Open anterior approaches for lumbar spine procedures.

With the advent of anterior lumbar interbody fusion (ALIF) and artificial discs as common procedures for the treatment many spinal problems such as pseudoarthrosis, degenerative disc disease and internal disc disruption from trauma, anterior exposure has become an increasingly popular procedure for the general, thoracic, urologic and vascular surgeon. Despite this, the body of literature describing this procedure is lacking. Dividing the approach for anterior spinal surgery into the thoracolumbar, mid-lumbar, and lumbosacral regions, we describe the basic techniques and anatomy needed to perform these open approaches, specifically, repairs of disc spaces T12-L2, L2-5, and L5-S1, respectively. The technique for the retroperitoneal approach will be discussed in detail; however, issues involved with indications for transperitoneal approach and technical "pearls" will also be discussed.