Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.

BACKGROUND: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. METHODS: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. RESULTS: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. CONCLUSIONS: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up.

STUDY DESIGN: Randomized, controlled, prospective (AAOS therapeutic level I) trial conducted under Food and Drug Administration Investigational Device Exemption hypothesized noninferiority of a novel bioactive composite material to polymethylmethacrylate (PMMA). OBJECTIVE: To determine the safety and efficacy of a new, nonresorbable bioactive composite (Cortoss) compared with PMMA, the standard treatment of vertebral compression fractures (VCFs). SUMMARY OF BACKGROUND DATA: Vertebroplasty with PMMA, the widely adopted treatment for VCFs nonresponsive to conservative care, provides effective, immediate pain relief, but the material has received criticism for its properties. A new bioactive composite material designed specifically for vertebroplasty showed promising results in animals and nonrandomized clinical studies and was subsequently compared with PMMA in a randomized study. This study represents the first prospective study evaluating vertebroplasty comparing PMMA with another material with 24-month follow-up. METHODS: Using 2:1 randomization, vertebroplasty was performed with Cortoss on 162 patients and PMMA on 94 patients. Inclusion criteria were painful osteoporotic VCFs with a visual analogue scale pain score of at least 50 mm on a 100-mm scale and at least 30% disability as measured by the Oswestry Disability Index. Evaluations at pretreatment, treatment day, and 7 posttreatment intervals out to 24 months included pain, disability, neurological status, adverse events, quality of life, patient satisfaction, analgesic use, and independently reviewed radiographs. RESULTS: Noninferiority of Cortoss relative to PMMA was observed, with Cortoss-treated patients experiencing significant pain relief at 3 months (P = 0.0395) and better maintenance or improvement in function at 24 months (P = 0.0299). Incidence of serious device-related adverse events was 4.3% in both groups; none were life threatening. CONCLUSION: Vertebroplasty using either Cortoss or PMMA provides effective, immediate, and lasting pain relief and prevents further loss of function. Both materials performed comparably at most time points; Cortoss demonstrated better results for pain reduction at 3 months and for function at 24 months.

Unilateral transforaminal posterior lumbar interbody fusion (TLIF): indications, technique, and 2-year results.

A prospective analysis of consecutive cases of lumbar fusion using the unilateral transforaminal posterior lumbar interbody fusion (TLIF) technique with pedicle screw fixation. The objective of the study was to assess the clinical and radiographic outcome of TLIF and describe the technique and indications in the treatment of degenerative disease of the lumbar spine. Forty patients treated with TLIF for degenerative diseases of the lumbar spine were followed up for a minimum of 2.5 years (mean: 36 months; range: 30-42 months). Twenty-three patients had degenerative disc disease alone, 13 had associated isthmic or degenerative spondylolisthesis, and 4 had recurrent disc herniations at the L4-L5 level. Thirty-six (90%) had solid fusions radiographically at latest follow-up. Seventy-nine percent had excellent or good clinical outcomes. Our patients demonstrated high fusion rates and patient satisfaction.

Unilateral transforaminal posterior lumbar interbody fusion.

A prospective analysis of consecutive patients who had lumbar fusion using the unilateral transforaminal posterior lumbar interbody fusion with pedicle screw fixation is presented to assess the clinical and radiographic outcomes of the transforaminal posterior lumbar interbody fusion procedure and describe the technique and indication in the treatment of degenerative disease of the lumbar spine. Forty patients treated with transforaminal posterior lumbar interbody fusion for degenerative diseases of the lumbar spine (with anterior column deficiency) were followed up for a minimum of 3 years (mean, 3.4 years; range, 3-3.9 years). Radiographic assessment included plain and flexion and extension radiographs. Clinical outcome was based on pain relief, ability to do activities of daily living, and return to work. Thirty-six patients (90%) had solid fusions and at latest followup, segmental lordosis has increased in all patients. Eighty-five percent of patients had excellent or good clinical outcome(s). The unilateral transforaminal posterior lumbar interbody fusion provides bilateral anterior column support through a unilateral approach. The patients had high fusion rates and patient satisfaction as reported with similar complications found in other methods commonly used for spinal decompression and stabilization.