Maintenance of Segmental Lordosis and Disk Height in Stand-alone and Instrumented Extreme Lateral Interbody Fusion (XLIF).

STUDY DESIGN: A prospective single-surgeon nonrandomized clinical study. OBJECTIVE: To evaluate the radiographic and clinical outcomes, by fixation type, in extreme lateral interbody fusion (XLIF) patients and provide an algorithm for determining patients suitable for stand-alone XLIF. SUMMARY OF BACKGROUND DATA: XLIF may be supplemented with pedicle screw fixation, however, since stabilizing structures remain intact, it is suggested that stand-alone XLIF can be used for certain indications. This eliminates the associated morbidity, though subsidence rates may be elevated, potentially minimizing the clinical benefits. MATERIALS AND METHODS: A fixation algorithm was developed after evaluation of patient outcomes from the surgeon's first 30 cases. This algorithm was used prospectively for 40 subsequent patients to determine the requirement for supplemental fixation. Preoperative, postoperative, and 12-month follow-up computed tomography scans were measured for segmental and global lumbar lordosis and posterior disk height. Clinical outcome measures included back and leg pain (visual analogue scale), Oswestry Disability Index (ODI), and SF-36 physical and mental component scores (PCS and MCS). RESULTS: Preoperatively to 12-month follow-up there were increases in segmental lordosis (7.9-9.4 degrees, P=0.0497), lumbar lordosis (48.8-55.2 degrees, P=0.0328), and disk height (3.7-5.5 mm, P=0.0018); there were also improvements in back (58.6%) and leg pain (60.0%), ODI (44.4%), PCS (56.7%), and MCS (16.1%) for stand-alone XLIF. For instrumented XLIF, segmental lordosis (7.6-10.5 degrees, P=0.0120) and disk height (3.5-5.6 mm, P<0.001) increased, while lumbar lordosis decreased (51.1-45.8 degrees, P=0.2560). Back (49.8%) and leg pain (30.8%), ODI (32.3%), PCS (37.4%), and MCS (2.0%) were all improved. Subsidence occurred in 3 (7.5%) stand-alone patients. CONCLUSIONS: The XLIF treatment fixation algorithm provided a clinical pathway to select suitable patients for stand-alone XLIF. These patients achieved positive clinical outcomes, satisfactory fusion rates, with sustained correction of lordosis and restoration of disk height.

Anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2: a prospective study of complications.

OBJECT: The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in anterior lumbar interbody fusion (ALIF) is controversial regarding the reported complication rates and cost. The authors aimed to assess the complication rates of performing ALIF using rhBMP-2. METHODS: This is a prospective study of consecutive patients who underwent ALIF performed by a single spine surgeon and a single vascular surgeon between 2009 and 2012. All patients underwent placement of a polyetheretherketone (PEEK) cage filled with rhBMP-2 and a separate anterior titanium plate. Preoperative clinical data, operative details, postoperative complications, and clinical and radiographic outcomes were recorded for all patients. Clinical outcome measures included back and leg pain visual analog scale scores, Oswestry Disability Index (ODI), and SF-36 Physical and Mental Component Summary (PCS and MCS) scores. Radiographic assessment of fusion was performed using high-definition CT scanning. Male patients were screened pre- and postoperatively regarding sexual dysfunction, specifically retrograde ejaculation (RE). RESULTS: The study comprised 131 patients with a mean age of 45.3 years. There were 67 men (51.1%) and 64 women (48.9%). Of the 131 patients, 117 (89.3%) underwent ALIF at L5-S1, 9 (6.9%) at L4-5, and 5 (3.8%) at both L4-5 and L5-S1. The overall complication rate was 19.1% (25 of 131), with 17 patients (13.0%) experiencing minor complications and 8 (6.1%) experiencing major complications. The mean estimated blood loss per ALIF level was 115 ml. There was 1 incidence (1.5%) of RE. No significant vascular injuries occurred. No prosthesis failure occurred with the PEEK cage and separate anterior screw-plate. Back and leg pain improved 57.2% and 61.8%, respectively. The ODI improved 54.3%, with PCS and MCS scores improving 41.7% and 21.3%, respectively. Solid interbody fusion was observed in 96.9% of patients at 12 months. CONCLUSIONS: Anterior lumbar interbody fusion with a vascular access surgeon and spine surgeon, using a separate cage and anterior screw-plate, provides a very robust and reliable construct with low complication rates, high fusion rates, and positive clinical outcomes, and it is cost-effective. The authors did not experience the high rates of RE reported by other authors using rhBMP-2.

Cervical artificial disc replacement with ProDisc-C: clinical and radiographic outcomes with long-term follow-up.

Cervical artificial disc replacement (ADR) is indicated for the treatment of severe radiculopathy permitting neural decompression and maintenance of motion. We evaluated the clinical and radiographic outcomes in cervical ADR patients using the ProDisc-C device (DePuy Synthes, West Chester, PA, USA) with a 5-9 year follow-up. Data were collected through a prospective registry, with retrospective analysis performed on 24 consecutive patients treated with cervical ADR by a single surgeon. All patients underwent single- or two-level ADR with the ProDisc-C device. Outcome measures included neck and arm pain (visual analogue scale), disability (neck disability index [NDI]), complications and secondary surgery rates. Flexion-extension cervical radiographs were performed to assess range of motion (ROM) of the device and adjacent segment disease (ASD). Average follow-up was 7.7 years. Neck and arm pain improved 60% and 79%, respectively, and NDI had an improvement of 58%. There were no episodes of device migration or subsidence. Mean ROM of the device was 6.4°. Heterotopic ossification was present in seven patients (37%). Radiographic ASD below the device developed in four patients (21%) (one single-level and three two-level ADR). No patient required secondary surgery (repeat operations at the index level or adjacent levels). Fourteen out of 19 patients (74%) were able to return to employment, with a median return to work time of 1.3 months. The ProDisc-C device for cervical ADR is a safe option for patients providing excellent clinical outcomes, satisfactory return to work rates and maintenance of segmental motion despite radiographic evidence of heterotopic ossification and ASD on long-term follow-up.

Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions.

INTRODUCTION: The lateral transpsoas approach for lumbar interbody fusion (XLIF) is gaining popularity. Studies examining a surgeon's early experience are rare. We aim to report treatment, complication, clinical, and radiographic outcomes in an early series of patients. METHODS: Prospective data from the first thirty patients treated with XLIF by a single surgeon was reviewed. Outcome measures included pain, disability, and quality of life assessment. Radiographic assessment of fusion was performed by computed tomography. RESULTS: Average follow-up was 11.5 months, operative time was 60 minutes per level and blood loss was 50 mL. Complications were observed: clinical subsidence, cage breakage upon insertion, new postoperative motor deficit and bowel injury. Approach side-effects were radiographic subsidence and anterior thigh sensory changes. Two patients required reoperation; microforaminotomy and pedicle screw fixation respectively. VAS back and leg pain decreased 63% and 56%, respectively. ODI improved 41.2% with 51.3% and 8.1% improvements in PCS and MCS. Complete fusion (last follow-up) was observed in 85%. CONCLUSION: The XLIF approach provides superior treatment, clinical outcomes and fusion rates compared to conventional surgical approaches with lowered complication rates. Mentor supervision for early cases and strict adherence to the surgical technique including neuromonitoring is essential.