Operating Costs of Full-endoscopic Lumbar Spine Surgery in Japan.

For full-endoscopic lumbar discectomy, operating costs are also important because expensive equipment are necessary. We surveyed the operating costs of surgical equipment necessary for full-endoscopic surgery together with surgical procedure reimbursement fees. A total of 295 cases of full-endoscopic surgery via a transforaminal approach were retrospectively analyzed. We calculated the frequency of damage and the unit purchase price of devices such as endoscopes, and surgical instruments such as grasping forceps for nucleotomy, high-speed drill bar, and bipolar forceps, and examined the operating costs in Japanese yen against the procedure fee per case. Endoscope breakage occurred seven times, and a payment of ¥760,000 was necessary for trade-in and purchase of a new endoscope. The total breakage number of grasping forceps was 58, and the purchase price per unit was ¥116,000. Therefore, a total of ¥12,020,000 was required for the 295 cases, and the calculated operating cost that accompanies equipment breakage was ¥40,000 per case. In addition, about ¥118,000 was required for disposable bipolar forceps and high-speed drill bar to be used intraoperatively for each case. Thus, for one case it is calculated that total ¥158,000 is utilized for equipment from the surgical reimbursement fee per case specified by the Japanese Ministry of Health being ¥303,900. Minimally invasive procedures provide great benefit to patients; however, the eventual contribution to hospital profits is small and may not be sufficient. To resolve this issue, the cost of surgical equipment should be lowered and/or the surgical reimbursement fee of the full-endoscopic surgery should be raised.

Postoperative direct health care costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients.

BACKGROUND CONTEXT: Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system. PURPOSE: To compare the direct health care costs through 5 years follow-up of conventional discectomy (Control) with those of discectomy supplemented by an adjunctive annular closure device (ACD) in high-risk patients with large annular defects. STUDY DESIGN: This was a cost-effectiveness study. METHODS: All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer (Humana) direct costs were derived from a commercially available payer database to estimate costs in the US healthcare system, including those associated with facility, surgeon, imaging, follow-up visits, physical therapy, and injections. A 50:50 split between Medicare and commercial insurers was assumed for the base case analysis. The analysis was also performed on a 80:20 commercial:Medicare payer basis. For the base case scenario, a 2-year time horizon and outpatient cost setting was established for the index procedure. Repeat discectomy was assumed to be performed on a 60:40 outpatient-to-inpatient basis. Complications requiring surgery, revisions, and/or fusion were assumed to be managed in the inpatient setting. Total costs of reoperation and per-patient costs of reoperation were compared between groups for both forms of insurers. One author received consulting fees of <$50,000 for the completion of this study, and the other eight authors did not have any financial associations with the current work. Funding for this study was provided by Intrinsic Therapeutics, but all analyses, interpretation, and writing were performed independently by the authors. RESULTS: At two years follow-up, use of the ACD reduced the rate of symptomatic reherniations in a large defect population to 13% compared with 25% in the control group (p<.001). This reduction in symptomatic reherniations in the ACD group translated to a savings of $2,802 per patient in direct health care costs compared with Control at 2 years and $5,315 per patient by 5 years based on 50% private and 50% public (Medicare) payer split. Under the scenario of 80:20 private:public insurance reimbursement, the estimated direct cost savings were $3,215 and $6,099 per patient at 2- and 5-years postoperatively, respectively, with the use of the ACD. CONCLUSIONS: Symptomatic reherniation and reoperation rates were nearly double among control patients compared with ACD-treated patients, which translated to markedly greater per-patient healthcare costs in the control group, where the ACD was not used.

Cervical Template to Optimize the Plate-to-Disc Distance in Instrumented Anterior Cervical Discectomies and Fusions: Instrumentation Assessment.

BACKGROUND: An increased incidence of adjacent segment degeneration in the cervical spine has been associated with a plate-to-disc distance (PDD) of <5 mm. OBJECTIVE: To introduce a template to size, position, and secure a cervical plate and ensure a 5-mm minimum PDD. METHODS: A prospective observational study was performed on 50 consecutive patients who had single-level anterior cervical discectomy and fusion (ACDF) using a cervical template. The cervical template was secured into the interbody spacer and assessed for length, PDD, and adequate vertebral body coverage. Holes were drilled through the template, which was then removed for cervical plate placement. Postoperative radiographs were assessed for PDD to adjacent segments, the angle from the vertical axis of the spine, and distance from midline. Neck Disability Index and visual analog scale scores for the neck and arm were obtained preoperatively and at 30-d and 90-d follow-up. RESULTS: Fifty patients underwent single-level ACDFs. The mean angle from the long axis of the spine was 2.4 (0.0-4.4) degrees; mean distance from midline was 1.3 (0.0-2.8) mm; and mean distance from the plate ends to the adjacent segments above was 5.4 (4.6-6.2) mm, and below, 5.1 (4.3-5.8) mm. CONCLUSION: A cervical template can reliably secure the midline and predetermine the size of the shortest cervical plate for adequately stabilizing the segment for arthrodesis. Use of a template standardizes the process of maximizing the PDD.

A comparison of a self-locking stand-alone cage and anterior cervical plate for ACDF: Minimum 3-year assessment of radiographic and clinical outcomes.

OBJECTIVES: The self-locking stand-alone cage has been clinically applied in treating cervical degenerative disc disease (CDDD). However, no long-term clinical and radiographic studies have been performed so far. This retrospective study was designed to analyze and compare the efficacy and outcomes of anterior cervical discectomy and fusion (ACDF) using self-locking stand-alone cages and cages with the anterior cervical plating system. PATIENTS AND METHODS: A total of 98 consecutive patients were recruited in this study. Patients in the cage group were given stand-alone self-locking cages, and patients in the plate group were treated with cages and anterior plate fixation. The operative time, intraoperative blood loss and complications were recorded. Clinical outcomes were evaluated using the JOA scoring system, Neck Disability Index and Odom's criteria. The cervical lordosis, subsidence and cervical fusion status were assessed by X-ray and computed tomography. RESULTS: The mean follow-up period was 39.7 months in the cage group and 42.2 months in the plate group. The operative time, intraoperative blood loss, postoperative dysphagia, sore throat and adjacent segment degeneration in the cage group were significantly less than those in the plate group (p < 0.05). All the patients in both groups achieved complete interbody fusion. Postoperative JOA and NDI scores in both groups were obviously improved compared with the preoperative ones. The postoperative cervical lordosis was effectively restored in both groups. CONCLUSIONS: The self-locking stand-alone cage for ACDF could effectively restore the cervical physiological curvature, cause few complications, and lead to satisfactory outcomes. Therefore, it could be used as an effective and reliable treatment for the CDDD.

Assessment of BioPlex interbody fusion device in a sheep lumbar fusion model.

OBJECTIVE: The purpose of this study was to evaluate the bioPlex bioresorbable interbody device in a sheep lumbar fusion model and compare it to the concorde, a standard carbon fiber interbody cage. BACKGROUND: Lumbar interbody fusion devices are made from a variety of materials, including titanium alloys, carbon-fiber, and PEEK. The BioPlex Continuous Phase Composite (CPC) is a unique bioresorbable material comprised of Pro Osteon 500R and 70:30 Poly (L/D, L-lactic acid). The BioPlex device is radiolucent, resorbable and due to its bulk nanoporosity of 8%, has a more consistent degradation profile as compared to a polymer alone. METHODS: A total of twenty five male Suffolk sheep were used in this study; nineteen of which were implanted with a bioPlex or concorde device at the L3-L4 and L5-L6 levels using a modified transforaminal/lateral approach. A discectomy was performed and each implant (filled with autologous bone) was placed within the disc space. The sheep were sacrificed at 6, 12, 24 months postimplantation. Fusion was assessed via motion, radiographic and histological data. RESULTS: The BioPlex and Concorde implanted levels had significantly less motion (p<0.05) than the normal controls in flexion/extension and lateral bending at 6, 12, and 24 months. No significant difference in motion was detected between the bioPlex and concorde implants. CT fusion scores correlated with the motion analysis in all the three cases. CONCLUSION: In comparison to the concorde device, the bioPlex implant appears to have equivalent radiographic and biomechanical fusion success.

Influence of surgical experience on the efficiency of discectomy in TLIF: a cadaveric testing in 40 levels.

STUDY DESIGN: Cadaveric study. OBJECTIVE: The purpose of this study was to assess the influence of surgical experience on the efficiency of lumbar discectomy in open transforaminal lumbar interbody fusion. SUMMARY OF BACKGROUND DATA: There is limited knowledge about the efficiency of discectomy among surgeons. As a first study, we are evaluating the effect of surgical experience on it. METHODS: Manual and powered discectomies were randomized and performed by 3 attending spine surgeons and 2 clinical spine fellows. Each discectomy procedure was analyzed for the area of complete endplate preparation, total elapsed time, and number of instrument passes. The surface area of discectomy at each endplate was measured utilizing digital imaging and the appropriate software. For the purpose of the analysis, the superior and the inferior endplates were divided into ipsilateral and contralateral halves, and each half was further divided into ventral and dorsal quadrants. Each quadrant was analyzed in a blinded manner by 2 observers. RESULTS: A total of 40 discectomies were performed on 9 fresh-frozen cadaveric torsos between the levels T12 and S1. A powered discectomy device was used in levels 9 and 11 by the attendings. Manual discectomy was performed in 11 levels by the spine fellows and 9 by the spine attendings. No significant difference was observed between the spine fellows and spine attendings when the manual instruments were used (P = 0.924). However, the spine attending surgeon group had a significantly increased total area of discectomy compared with the fellows (P = 0.003). No significant difference was observed between the groups when instrument passes or the total elapsed time were compared either utilizing the manual or the powered technique. CONCLUSIONS: Our results demonstrate that a satisfactory discectomy may be performed by surgeons with relatively less surgical experience in the transforaminal approach using a powered discectomy device.

Reducing the cost and frequency of explantations associated with single-level anterior diskectomy and fusion at a single institution through education.

STUDY DESIGN: We prospectively evaluated the costs/frequency of explanted instrumentation (devices implanted but removed prior to closure) for all single-level anterior diskectomy (1-ADF) procedures performed in 2010 at a single institution before and after surgeon education. OBJECTIVE: To determine whether surgeon education would reduce the costs/frequency of explantation for 1-ADF. SUMMARY OF BACKGROUND DATA: In 2009, we reported that the cost of explanted devices was 9.2% of the cost of implanted devices. METHODS: The costs/frequencies of explantation for 1-ADF performed in 2010 at the same institution by the same surgeons were analyzed before and after surgeon education. From January through April, surgeons were unaware of concerns regarding explantation. At the end of April 2010, spinal surgeons were educated about explantation costs/frequency at 2 meetings. Explantation costs/frequencies for the first 4 months of 2010 were compared with those for the last 8 months as well as with the results from 2009. RESULTS: Prior to surgeon education, instrumentation was explanted in 45.5% of the cases, whereas after education explantation occurred in 16% of the cases. The explantation rate (the number of explanted devices as a percentage of implanted devices) was lower after education for screws (12.5% vs. 7.7%), plates (9.4% vs. 0%), and allograft spacers (7.1% vs. 2.9%), and lower than for rates from 2009. In 2010, the overall cost of explanted devices as a percentage of implanted devices was also lower after surgeon education (5.8%) than before surgeon education in 2010 (20.0%) or 2009 (9.2%). CONCLUSION: The frequency and cost of explanted instrumentation used to perform 1-ADF were reduced through surgeon education.

SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses.

SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of "coverage with evidence development". It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3-29.4 points preop to 1-year postop, p < 0.0001) leg pain VAS (55.5-19.1 points preop to 1-year postop, p < 0.001), improvement of quality of life (EQ-5D, 0.32-0.73 points preop to 1-year postop, p < 0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with 1 [corrected] new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS "threshold value" of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.