Journal of neurosurgery. Spine
-
Randomized Controlled Trial Multicenter Study Comparative Study
Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.
OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. ⋯ CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).
-
Randomized Controlled Trial
Percutaneous transforaminal endoscopic discectomy compared with microendoscopic discectomy for lumbar disc herniation: 1-year results of an ongoing randomized controlled trial.
OBJECTIVE A prospective randomized controlled study was conducted to clarify whether percutaneous transforaminal endoscopic discectomy (PTED) results in better clinical outcomes and less surgical trauma than microendoscopic discectomy (MED). METHODS In this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed lumbar disc herniation. Patients were randomly allocated to the PTED or the MED group by computer-generated randomization codes. ⋯ CONCLUSIONS Over the 1-year follow-up period, PTED did not show superior clinical outcomes and did not seem to be a safer procedure for patients with lumbar disc herniation compared with MED. PTED had inferior results for median disc herniation, whereas MED did not seem to be the best treatment option for far-lateral disc herniation. Clinical trial registration no.: NCT01997086 (clinicaltrials.gov).
-
OBJECTIVE This study aimed to evaluate the clinical outcomes of percutaneous endoscopic transforaminal discectomy (PETD), microendoscopic discectomy (MED), and microdiscectomy (MD) for treatment of symptomatic lumbar disc herniation (LDH). METHODS One hundred ninety-two patients with symptomatic LDH at L3-4 and L4-5 were included in this study. The mean (± SD) age of patients was 34.2 ± 2.6 years (range 18-62 years). ⋯ Three cases (5.5%) in the PETD group had recurrent LDH, and 2 recurrent cases (3.4%) were confirmed in the MED group. CONCLUSIONS PETD, MED, and MD were all reliable techniques for the treatment of symptomatic LDH. With a restricted indication, PETD can result in rapid recovery and better clinical results after at least 2 years of follow-up.
-
OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS), which is funded by the National Institutes of Health, is a set of adaptive, responsive assessment tools that measures patient-reported health status. PROMIS measures have not been validated for surgical patients with cervical spine disorders. The objective of this project is to evaluate the validity (e.g., convergent validity, known-groups validity, responsiveness to change) of PROMIS computer adaptive tests (CATs) for pain behavior, pain interference, and physical function in patients undergoing cervical spine surgery. ⋯ CONCLUSIONS This study verifies that PROMIS CATs demonstrate convergent and known-groups validity and comparable responsiveness to change as existing legacy measures. The PROMIS measures required less time for completion than legacy measures. The validity and efficiency of the PROMIS measures in surgical patients with cervical spine disorders suggest an improvement over legacy measures and an opportunity for incorporation into clinical practice.
-
OBJECTIVE The aim of this study was to characterize the association between percentage change in hemoglobin (ΔHb)-i.e., the difference between preoperative Hb and in-hospital nadir Hb concentration-and perioperative adverse events among spine surgery patients. METHODS Patients who underwent spine surgery at the authors' institution between December 4, 2008, and June 26, 2015, were eligible for this retrospective study. Patients who underwent the following procedures were included: atlantoaxial fusion, subaxial anterior cervical fusion, subaxial posterior cervical fusion, anterior lumbar fusion, posterior lumbar fusion, lateral lumbar fusion, excision of intervertebral disc, and excision of spinal cord lesion. ⋯ Hospital-related infection, which occurred in 60 patients (1.5%), was also more common in patients with greater percentage ΔHb (p = 0.001). CONCLUSIONS Percentage ΔHb is independently associated with a higher risk of developing any perioperative complication and hospital-related infection. The authors' results suggest that percentage ΔHb may be a useful measure for identifying patients at risk for adverse perioperative events.