Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial.

BACKGROUND: The optimal configuration for spinopelvic fixation during multilevel spine fusion surgery for adult spine deformity remains unclear. Postoperative sacroiliac (SI) joint pain, S2AI screw loosening and implant breakage could be related to continued motion of the SI joint with use of only a single point of fixation across the SI joint. METHODS: Prospective, international, multicenter randomized controlled trial of 222 patients with adult spine deformity scheduled for multilevel (4 or more levels) spine fusion surgery with pelvic fixation. Subjects were randomized to sacroalar (S2) iliac (S2AI) screws alone for pelvic fixation or S2AI + triangular titanium implants placed cephalad to S2AI screws. Quad rod techniques were not allowed or used. Baseline spinal deformity measures were read by an independent radiologist. Site-reported perioperative adverse events were reviewed by a clinical events committee. Quality of life questionnaires and other clinical outcomes are in process with planned 2-year follow-up. RESULTS: One hundred thirteen participants were assigned to S2AI and 109 to S2AI + titanium triangular implants (TTI). 35/222 (16%) of all subjects had a history of SI joint pain or were diagnosed with SI joint pain during preoperative workup. Three-month follow-up was available in all but 4 subjects. TTI placement was successful in 106 of 109 (98%) subjects assigned to TTI. In 2 cases, TTI could not be placed due to anatomical considerations. Three TTI ventral iliac breaches were observed, all of which were managed non-surgically. One TTI subject had a transverse sacral fracture and 1 TTI subject had malposition of the implant requiring removal. CONCLUSIONS: SI joint pain is common in patients with adult spinal deformity who are candidates for multilevel spine fusion surgery. Concurrent placement of TTI parallel to S2AI screws during multilevel spine fusion surgery is feasible and safe. Further follow-up will help to determine the clinical value of this approach to augment pelvic fixation.

Evaluation of DIAM™ Spinal Stabilization System for lower lumbar disc degenerative disease: A randomized, prospective, single-site study.

OBJECTIVE: To determine the efficacy of DIAM Spinal Stabilization System compared with nonoperative treatment for patients with low back pain and lower lumbar disc degenerative disease. METHODS: A single center collected prospective outcomes data on 38 patients randomized to an interspinous device or non-operative treatment for symptomatic lumbar degenerative disc disease with treatment crossover allowed at 6 months. RESULTS: At all postoperative timepoints out to 2-years, statistically significant improvements in ODI and back pain scores were observed with the interspinous device. Clinically significant improvements (ODI >15-point improvement) were seen in 87.5% of DIAM patients at 2-years postoperatively. A high cross-over rate was noted from the non-operative cohort to the operative group (12 of 15) due to continued pain with nonoperative care. Additionally, 80% of patients receiving the DIAM implant reported a >15-point ODI reduction from pre-surgical scores at 2-year follow-up. CONCLUSION: The DIAM device demonstrates improvement in ODI and Back Pain scores maintained out to a 2-year follow-up timepoint and performed superior to conventional nonoperative treatment regimens commonly used in low back pain.

Early outcomes and safety of outpatient (surgery center) vs inpatient based L5-S1 Anterior Lumbar Interbody Fusion.

We seek to determine the outcomes of patients undergoing outpatient-based ALIF compared to a consecutive series of inpatient based ALIF performed during the same time period. 58 consecutive patients at a single outpatient surgery center underwent ALIF from June 2015 - August 2017 and 79 ALIF's were performed at 2 Inpatient hospitals. Electronic medical records were reviewed for perioperative and postoperative complications as well as secondary interventions. 62 patients met inclusion criteria (29 Outpatient, 33 Inpatient). The inpatient group was significantly older (44 vs 51; p = 0.01). There were 8 postoperative complications. There was no difference in secondary interventions; 28 patients underwent a total of 36 interventions postoperatively for pain. Secondary interventions were performed at an average of 128(outpatient) and 158(inpatient) days (p = 0.55). There was no difference in outcome scores between the inpatient/outpatient groups at any time. Patients receiving a secondary intervention showed no significant improvement in Back VAS scores but, demonstrated a strong trend (p = 0.06) towards leg pain improvement. Patients who did not undergo secondary intervention had significant improvement in both Back and Leg VAS scores at all time points (p < 0.05). Outpatient ALIF is a safe and reproducible procedure with complication rates consistent with or lower than published rates. Patients outcome scores were no different in the inpatient versus outpatient group. Interestingly, there was a high number of secondary interventions performed in both groups. Patients undergoing a secondary procedure did not get statistically significant improvement in Back VAS but, demonstrated a strong trend in Leg VAS patient reported outcome scores.

No S.C.A.R.E. Protocol: A Streamlined Safety Protocol.

INTRODUCTION: Despite the proven success of anterior cervical surgery (ACS) postoperative issues can arise, with retropharyngeal hematoma (RH) being one of the most feared. A recent USA Today article highlighted the failed management and subsequent death of patients developing RH after ACS. The article calls into question the safety of performing ACS in an outpatient setting. METHODS: We tested the knowledge of 20 healthcare professionals (4 surgeons, 16 ancillary providers) regarding ways to minimize the post-ACS complications. We used a multiple-choice and fill-in-the-blank test. We then developed a No S.C.A.R.E. safety protocol and after teaching the same professionals, re-administered the examination to assess improvement. RESULTS: We identified large gaps in knowledge between spine surgeons and other providers (92.3% versus 31.2%) on preintervention testing. Postintervention testing showed significant improvement in nonsurgeon scores (31.2% to 86.1%, P < 0.01). Improvement was also seen in provider confidence after completion of the education module. CONCLUSION: Previous studies demonstrate that the incidence of RH necessitating evacuation after ACS is extremely small (<1%). For rare complications, healthcare teams may benefit from educational modules and standardized protocols. After implementation of our No S.C.A.R.E. protocol, provider knowledge and confidence markedly improved. We recommend similar education modules and protocols be used at other institutions performing ACS.

Does index level sagittal alignment determine adjacent level disc height loss?

OBJECTIVE: The authors sought to compare the effect of index level sagittal alignment on cephalad radiographic adjacent segment pathology (RASP) in patients undergoing cervical total disc arthroplasty (TDA) or anterior cervical discectomy and fusion (ACDF). METHODS: This was a retrospective study of prospectively collected radiographic data from 79 patients who underwent TDA or ACDF and were enrolled and followed prospectively at two centers in a multicenter FDA investigational device exemption trial of the Bryan cervical disc prosthesis used for arthroplasty. Neutral lateral radiographs were obtained pre- and postoperatively and at 1, 2, 4, and up to 7 years following surgery. The index level Cobb angle was measured both pre- and postoperatively. Cephalad disc degeneration was determined by a previously described measurement of the disc height/anteroposterior (AP) distance ratio. RESULTS: Sixty-eight patients (n = 33 ACDF; n = 35 TDA) had complete radiographs and were included for analysis. Preoperatively, there was no difference in the index level Cobb angle between the ACDF and TDA patients. Postoperatively, the ACDF patients had a larger segment lordosis compared to the TDA patients (p = 0.002). Patients who had a postoperative kyphotic Cobb angle were more likely to have undergone TDA (p = 0.01). A significant decrease in the disc height/AP distance ratio occurred over time (p = 0.035), by an average of 0.01818 at 84 months. However, this decrease was not influenced by preoperative alignment, postoperative alignment, or type of surgery. CONCLUSIONS: In this cohort of patients undergoing TDA and ACDF, the authors found that preoperative and postoperative sagittal alignment have no effect on RASP at follow-up of at least 7 years. They identified time as the only significant factor affecting RASP.

Increased acute postoperative wound problems following spinal fusion in overweight patients with adolescent idiopathic scoliosis.

This study assessed the rate of adverse wound events in individuals with adolescent idiopathic scoliosis who underwent a posterior spinal fusion and sought to determine if obesity was related to the rate of adverse wound events. A retrospective review of patients with adolescent idiopathic scoliosis that underwent posterior spinal fusion between 2001 and 2013 was performed. Preoperative, perioperative, and postoperative data, including wound adverse events, were obtained through medical record review. Using the Center for Disease Control BMI criteria, participants were grouped into overweight/obese (BMI%≥85 percentile) or healthy/underweight (BMI%<85 percentile) groups. Obesity and prolonged hospital stay were independent risk factors for increased risk of wound problems.