Joseph A. Sclafani

Complications Associated With the Initial Learning Curve of Minimally Invasive Spine Surgery: A Systematic Review

BackgroundThere is an inherently difficult learning curve associated with minimally invasive surgical (MIS) approaches to spinal decompression and fusion. The association between complication rate and the learning curve remains unclear.Questions/purposesWe performed a systematic review for articles that evaluated the learning curves of MIS procedures for the spine, defined as the change in frequency of complications and length of surgical time as case number increased, for five types of MIS for the spine.MethodsWe conducted a systematic review in the PubMed database using the terms “minimally invasive spine surgery AND complications AND learning curve” followed by a manual citation review of included manuscripts. Clinical outcome and learning curve metrics were categorized for analysis by surgical procedure (MIS lumbar decompression procedures, MIS transforaminal lumbar interbody fusion, percutaneous pedicle screw insertion, laparoscopic anterior lumbar interbody fusion, and MIS cervical procedures). As the most consistent parameters used to evaluate the learning curve were procedure time and complication rate as a function of chronologic case number, our analysis focused on these. The search strategy identified 15 original studies that included 966 minimally invasive procedures. Learning curve parameters were correlated to chronologic procedure number in 14 of these studies.ResultsThe most common learning curve complication for decompressive procedures was durotomy. For fusion procedures, the most common complications were implant malposition, neural injury, and nonunion. The overall postoperative complication rate was 11% (109 of 966 cases). The learning curve was overcome for operative time and complications as a function of case numbers in 20 to 30 consecutive cases for most techniques discussed within this review.ConclusionsThe quantitative assessment of the procedural learning curve for MIS techniques for the spine remains challenging because the MIS techniques have different learning curves and because they have not been assessed in a consistent manner across studies. Complication rates may be underestimated by the studies we identified because surgeons tend to select patients carefully during the early learning curve period. The field of MIS would benefit from a standardization of study design and collected parameters in future learning curve investigations.

Use of a quantitative pedicle screw accuracy system to assess new technology: Initial studies on O-arm navigation and its effect on the learning curve of percutaneous pedicle screw insertion.

Background A quantitative screw accuracy system is proposed that allows for high-fidelity discrimination between various methods of pedicle screw insertion. Our purpose was to study the utility of a quantitative screw accuracy scoring system to assess new imaging technologies and their effects on the minimally invasive spine learning curve. Methods By use of a hypothetical “perfect screw,” a scoring system is proposed that may be used to compare the position of a small number of screws inserted according to a desired optimal position. This study incorporates a retrospective review of imaging studies for 10 patients who underwent percutaneous pedicle screw placement with either navigation-assisted O-arm imaging or navigation-assisted C-arm imaging. For the learning-curve portion of the study, 2 cadaveric adult torsos were used for instrumentation. Computed tomography imaging studies were used in both studies to assess screw position in the pedicle and vertebral body in relation to an optimal screw by use of a quantitative scoring system to rate accuracy. Results The quantitative scoring system allowed a statistically significant accuracy difference to be ascertained between 2 different technologies using fewer data points than previously published methods. When this screw scoring system is applied to minimally invasive percutaneous pedicle screw insertion, an optimal screw position can be achieved with greater accuracy through navigation-assisted technology (O-arm with computer-assisted navigation). When the O-arm with computer-assisted navigation was used by a novice surgeon learning the technique of percutaneous screw insertion, screws were inserted in a shorter period without loss of accuracy. In contrast, use of the traditional C-arm fluoroscopy leads to a loss of accuracy with faster insertion times. Increased accuracy can be seen clinically when compared with fluoroscopic navigation. Conclusions The use of a quantitative scoring system allows for rapid assessment of screw accuracy. As additional technologies and new teaching techniques for pedicle screw insertion are developed, this scoring system may be useful as an early assessment tool.

The effect of anterior longitudinal ligament resection on lordosis correction during minimally invasive lateral lumbar interbody fusion: Biomechanical and radiographic feasibility of an integrated spacer/plate interbody reconstruction device

Background: Lateral lumbar interbody fusion is powerful for correcting degenerative conditions, yet sagittal correction remains limited by anterior longitudinal ligament tethering. Although lordosis has been restored via ligament release, biomechanical consequences remain unknown. Investigators examined radiographic and biomechanical of ligament release for restoration of lumbar lordosis. Methods: Six fresh‐frozen human cadaveric spines (L3–S1) were tested: (Miller et al., 1988) intact; (Battie et al., 1995) 8 mm spacer with intact anterior longitudinal ligament; (Cho et al., 2013) 8 mm spacer without intact ligament following ligament resection; (Galbusera et al., 2013) 13 mm lateral lumbar interbody fusion; (Goldstein et al., 2001) integrated 13 mm spacer. Focal lordosis and range of motion were assessed by applying pure moments in flexion‐extension, lateral bending, and axial rotation. Findings: Cadaveric radiographs showed significant improvement in lordosis correction following ligament resection (P < 0.05). The 8 mm spacer with ligament construct provided greatest stability relative to intact (P > 0.05) but did little to restore lordosis. Ligament release significantly destabilized the spine relative to intact in all modes and 8 mm with ligament in lateral bending and axial rotation (P < 0.05). Integrated lateral lumbar interbody fusion following ligament resection did not significantly differ from intact or from 8 mm with ligament in all testing modes (P > 0.05). Interpretation: Lordosis corrected by lateral lumbar interbody fusion can be improved by anterior longitudinal ligament resection, but significant construct instability and potential implant migration/dislodgment may result. This study shows that an added integrated lateral fixation system can significantly improve construct stability. Long‐term multicenter studies are needed. HighlightsSagittal correction is limited by anterior longitudinal ligament tethering.Lateral spacer with anterior longitudinal ligament release doubled lordosis.Integrated spacer limited destabilization after ligament release.

Validation and Analysis of a Multi-site MIS Prospective Registry Through Sub-analysis of an MIS TLIF Subgroup

Study Design Retrospective analysis of multi-site, prospectively collected database. Objective To assess the validity and utility of a prospective spine registry by sub-analysis of patients treated with MIS TLIF. Background The MIS registry is a large-scale, multi-center series of prospectively collected clinical information on outcomes, complications, and adverse events for minimally invasive spine procedures for the treatment of degenerative lumbar conditions. Methods Analysis was performed on the MIS Prospective Registry database. A subgroup of patients treated by MIS TLIF technique was identified. Statistical analyses were performed on pre and post-operative data collected using validated health related quality of life outcome tools. Missing 1-year patient follow-up data was obtained through progressive correspondence modalities. Results Data analysis was performed on 98 MIS TLIF patients (56 female, 42 male) with a median age of 64.5 years (range 25-91 years) which were extracted from a total registry population of 478 patients. The one year follow-up rate was 87%. A total of 64 single-level, 23 two-level, 3 three-level, and 3 combined TLIFs staged with an MIS lateral procedure were included. The primary surgical indications were spondylolisthesis (27%), central stenosis (25%), foraminal stenosis (14%), post-laminectomy syndrome (14%) and degenerative scoliosis (6%). The peri-operative blood transfusion rate was 3%. Complications included intraoperative dural tear (n = 3), deep wound infection (n = 2), superficial dehiscence/cellulitis (n = 2). There was a 4% re-operation rate at the 1 year post-operative time point. Half of patients were discharged within 2 days (range 1-11 days, mean 2.97 days, median 2 days). All patients that were discharged on the first post-operative day (n = 14) underwent a single-level MIS TLIF procedure and had significantly lower pre-op disability index score than those discharged on POD 3-5 (43.7 ± 15.5 vs. 56.0 ± 18.3, p = 0.04). Average ODI scores in the subgroup of patients that had reached the one year postoperative time point were 46.5 pre-op (n = 46), and 26.2 at 1 year post-op (n = 40, p = 0.0001). There was significant improvement in VAS scores: pre-operative (back = 6.7, leg = 5.4, n = 46), and 1 year post-operative (back = 3.2, leg = 1.7, n = 40, p = 0.0001). Patients with pre-operative ODI scores greater than 50 demonstrated significant improvement starting at the 6 week post-operative time point (24 point improvement, n = 46, p < 0.001). A pre-operative ODI between 35-50 showed significant improvement starting at 3 months (15.5 point improvement, n = 29, p = 0.05). Patients with a pre-operative ODI score less than 35 had an initial period of increased disability with a trend towards significant improvement by 3 months post-op (n = 20). Conclusions Initial findings of the MIS Prospective Registry show patients can be enrolled in a relatively short time period and patient based questionnaires can successfully be obtained through a combination of clinic follow-up appointments and remote correspondence. Outcomes of the MIS Registry MIS TLIF subgroup were consistent with previously published MIS TLIF studies. Sub-analysis of data collected through level-specific patient diagnosis and treatment modalities permits outcome analysis of a wide breadth of spinal conditions and interventions.

Clinical Outcomes After Cervical Transcorporeal Microdecompression and Vertebral Body Access Channel Repair.

Background Although anterior cervical decompression and fusion (ACDF) can be performed using minimally invasive techniques, the extensive removal of anatomical keystones during decompression requires a segmental fusion to restore biomechanical stability. Treatment with arthrodesis techniques may result in a prolonged recovery time, loss of motion, and the need for further treatment if a pseudarthosis or adjacent segment disease occur. Transcorporeal micro decompression (TCMD) is a newly developed motion sparing, minimally invasive anterior cervical spine decompression procedure that utilizes a small channel through the cervical vertebral body to decompress areas of central or foraminal stenosis while preserving the native disc. Cervical decompression with TCMD can be performed as a stand-alone or hybrid procedure with ACDF at the adjacent levels. This study retrospectively assesses patient based clinical outcome measures in patients treated with TCMD. Methods A retrospective, non-randomized, single-center chart review of single surgeon experience with patients undergoing TCMD both with and without adjacent level ACDF using both a trajectory control guide and access channel repair. Statistical analyses were performed on pre and post-operative data collected using visual analog scale (VAS) and neck disability index (NDI) outcome measures. Results Among 62 patients, there were no cases of neurovascular injury, CSF leak, transfusion, or migration of repair implement. Revision surgery was required in 6.4% (n=4) patients. A subanalysis of outcome metrics was performed for patients that underwent standalone TCMD (TCMD group, n=42) and TCMD with concurrent ACDF at one or more levels (TCMD+ACDF group, n=20). TCMD group NDI improved from 20.0 to 2.7 at 1 year (p=0.0001); Axial VAS improved from 5.5 to 0.6 (p=0.0001); and Radiating VAS improved from 7.0 to 0.7 (p=0.0001). TCMD+ACDF group NDI improved from 22.0 to 4.0 at 1 year (p=0.004); Axial VAS improved from 7.1 to 1.2 (p=0.01); and Radiating VAS trended towards significant improvement from 6.4 to 2.3 (p=0.09). Mean return to work was 10 days in the TCMD group and 57 days in the TCMD+ACDF group. Conclusions Within the limits of a retrospective, single-surgeon study, patients did experience both functional improvement and pain relief as measured by NDI and VAS respectively from standalone TCMD or combined ACDF / TCMD procedures. Definitive statements on long-term efficacy, disc space preservation, and motion preservation await further study.

Validity and reliability of a novel patient reported outcome tool to evaluate post-operative dysphagia, odynophagia, and voice (DOV) disability after anterior cervical procedures

Background Existing evaluative instruments for dysphagia, odynophagia, and voice disturbance are cumbersome, focus pre-dominately on dysphagia, and often require administration by a certified Speech Pathologist. This study was conducted to utilize widely accepted instruments such as the American Speech and Hearing Associations National Outcomes Measurement System (NOMS) and VAS pain scales to validate a novel, patient-reported instrument that quantifies the severity of post-operative dysphagia, odynophagia, and voice disabilities (DOV). Methods The DOV was developed and subjected to multiple rounds of face and content validation by representative patient cohorts and a panel of clinical experts. An established, prospective clinical registry was utilized to collect pre and post-operative VAS-swallow related pain and DOV measurements for subjects with recent anterior cervical procedures (n=25 content validation, n=20 criterion validation), or recent lumbar decompressions (n=33). NOMS evaluations were performed by a certified Speech Language Pathologist on the first post-operative day after minimally invasive anterior approaches to cervical reconstruction were performed in the criterion validation cohort. Results Content validity: Subjects with a recent anterior cervical procedure reported a significant increase in post-operative dysphagia (pre-op: 0.13±0.35, post-op: 1.08±1.41, p=0.01), odynophagia (pre-op: 0.24±0.69, post-op: 0.84±0.90, p=0.001), and voice (pre-op: 0.10±0.41, post-op: 0.88±0.92, p=0.0004) disturbance. In contrast, subjects with a recent lumbar procedure did not demonstrate a significant increase in post-operative dysphagia, odynophagia, or voice disturbance (p>0.05). Criterion validity: Chi-squared contingency testing for independence between converted NOMS and DOV instrument scores accepted linkage between the two instruments for dysphagia X2(DF: 12, n=20, Expected: 21.03, Observed: 24.4, p: 0.02) and voice X2(DF: 6, n=20, Expected: 12.60, Observed: 21.28, p: 0.002) dimensions. Similarly, converted swallow related VAS and DOV odynophagia instruments demonstrated linkage X2(DF: 9, n=20, Expected: 16.92, Observed: 24.21, p: 0.004). Internal Reliability: Chronbachs alpha coefficient of reliability was 0.74 between all DOV survey dimensions. Conclusions The DOV survey is a valid patient-reported instrument to rapidly and reliably detect post-operative swallow and voice dysfunction.

Arthrodesis Rate and Patient Reported Outcomes After Anterior Lumbar Interbody Fusion Utilizing a Plasma-Sprayed Titanium Coated PEEK Interbody Implant: A Retrospective, Observational Analysis

Background Anterior lumbar interbody fusion (ALIF) is utilized in symptomatic spinal disc destabilization due to degenerative lumbar disc disease, isthmic and degenerative spondylolisthesis, internal disc disruption, or pseudarthrosis after non-operative treatments fail. The addition of a plasma-sprayed titanium coating (PTC) to polyether ether ketone spacers (PEEK) may reduce the rate of implant subsidence or non-union secondary to poor osseous-integration of non-coated PEEK or metal interbody systems. Methods A retrospective, non-randomized, single-center chart review, evaluated the post-surgical follow-up data of patients receiving a PTC PEEK implant during single or multi-level ALIF procedures to determine the clinical efficacy and rate of arthrodesis after utilization of a coated spacer. Standard roentgenographs or computed tomography were used to identify successful arthrodesis following the ALIF procedure and longitudinal clinical improvements were determined by scores on the Visual Analog Scale (VAS) for low back and leg pain. Results Forty-four subjects (48% male, mean=53 years) were included in this chart review. Follow-up radiology demonstrated radiographic union with bridging bone formation across the interbody space for 42/44 (96%) individuals with solid arthrodesis occurring at an average of 7.3 ± 2.3 months. Subjects demonstrated significant improvement in VAS low back pain (4.5 ± 2.4 point improvement, p=0.0001) and VAS leg pain (4.1 ± 3.3 point improvement, p=0.0001). While there was a significant reduction in the improvement of VAS low back pain of Workers Compensation claimants as compared to other patients (3.9 ± 2.4 vs. 5.3 ± 2.1), there was no difference in VAS low back pain or leg pain when the data was stratified by gender, age, tobacco use, comorbidities, prior surgery, fusion construct length, use of supplemental posterior instrumentation, BMI, or diagnosis. Conclusions This study provides support that the addition of a PTC coating to a zero-profile PEEK lumbar interbody spacer facilitates rapid and stable fixation at the bone-implant interface. This facilitated osteogenesis is associated with significantly improved pain outcomes, low implant subsidence and a high definitive rate of arthrodesis. Future studies should include a prospective, randomized, controlled, multi-center approach to directly compare arthrodesis rates and clinical outcomes longitudinally between standard PEEK and biomaterial-coated PEEK interbody spacer systems.

Outcome Measures of an Intracanal, Endoscopic Transforaminal Decompression Technique: Initial Findings from the MIS Prospective Registry.

Background Minimally invasive transforaminal endoscopic procedures can achieve spinal decompression through either direct or indirect techniques. Subtle variations in trajectory of the surgical corridor can dictate access to the pathologic tissue. Two general strategies exist: the intradiscal “inside-out” technique and the extradiscal, intracanal (IC) technique. The IC technique utilizes a more lateral transforaminal approach than the intradiscal technique, which allows for a more direct decompression of the spinal canal. Objective This study is an assessment of IC patient outcome data obtained through analysis of a previously validated MIS Prospective Registry. Methods Post-hoc analysis was performed on the MIS Prospective Registry database containing 1032 patients. A subgroup of patients treated with the endoscopic IC technique was identified. Patient outcome measures after treatment of symptomatic disk herniation and neuroforaminal stenosis were evaluated. Results A total of 86 IC patients were analyzed. Overall, there was significant improvement in employment and walking tolerance as soon as 6 weeks post-op as well as significant one year VAS and ODI score improvement. Subanalysis of IC patients with two distinct primary diagnoses was performed. Group IC-1 (disc herniation) showed improvement in ODI and VAS back and leg outcomes at 1 year post-op. Group IC-2 (foraminal stenosis) showed VAS back and leg score improvement at one year post-op but did not demonstrate significant improvement in overall ODI outcome at any time point. The one year re-operation rate was 2% (1/40) for group IC-1 and 28% (5/18) for group IC-2. Conclusions The initial results of the MIS Registry IC subgroup show a significant clinical improvement when the technique is employed to treat patients with lumbar disc herniation. The treatment of foraminal stenosis can lead to improved short-term clinical outcome but is associated with a high re-operation rate at 1 year post-op.