Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome.
China ; Clinical Trials as Topic ; standards ; Cohort Studies ; Endpoint Determination ; Humans ; Research Design ; standards ; Spinal Fusion ; instrumentation

BACKGROUNDThe purpose of this retrospective study was to compare the surgical outcomes of simple discectomy and instrumented posterior lumbar interbody fusion (iPLIF) in patients with lumbar disc herniation and Modic endplate changes. Our hypothesis was that iPLIF could provide better outcome for patients with refractory lumbar disc herniation and Modic changes (LDH-MC).

METHODSNinety-one patients with single-segment LDH-MC were recruited. All patients experienced low back pain as well as radicular leg pain, and low back pain was more severe than leg pain. Forty-seven patients were treated with discectomy and 44 were treated with iPLIF. The outcomes of both low back pain and radicular leg pain using visual analogue scale (VAS) as well as the clinical outcome related to low back pain using Japanese Orthopaedic Association (JOA) score were assessed before and 18 months after surgery, respectively.

RESULTSBoth low back and leg pain were significantly improved 18 months after simple discectomy and iPLIF. Compared to patients undergoing simple discectomy, low back pain was significantly reduced in patients undergoing iPLIF, but there was no significant difference in leg pain between two groups. Solid fusion was achieved in all patients who underwent iPLIF.

CONCLUSIONSIn patients with LDH-MC, iPLIF can yield significantly superior outcome on the relief of low back pain compared to simple discectomy. Simple discectomy can relieve radicular leg pain as efficient as iPLIF. Accordingly, iPLIF seems to be a reliable treatment for patients with LDH-MC and predominant low back pain.

Adult ; Diskectomy ; standards ; Female ; Humans ; Intervertebral Disc Displacement ; surgery ; Low Back Pain ; surgery ; Lumbar Vertebrae ; surgery ; Middle Aged ; Retrospective Studies ; Spinal Fusion ; standards

OBJECTIVETo probe the accuracy and safety of using an aiming device in the transpedicular fixation of cervical spine.

METHODSEight cervical specimens were obtained. We used the computed tomography (CT) to scan C3 to C7, measured the medial angle of the pedicle, and determined the location of the pedicle projecting on the articular process. Then we took the oblique X-ray film, measured the cephalic/caudal angle of the pedicle, and determined the location of the pedicle projecting on the articular process. All the specimens were equally divided into two groups. Screws of 2.8 mm x 30 mm, were used. Specimens in one group were inserted with the transpedicular screw manually, while specimens in the other one inserted with the transpedicular screw using a self-designed aiming device that can be modulate at the three dimensions according to the angles of the pedicles.

RESULTSThe first group totally had 40 screws from C3 to C7. There were 13 screws in the pedicle, 9 violated the walls of the pedicle but not involved the adjunct structure, and 18 injured the important structure such as spinal cord, verteberal artery, or nerve root. In the other group, only 4 screws violated the walls of the pedicle but not involved the adjunct structure, and the others all in the pedicles. The difference was of statistical significance (P < 0.01).

CONCLUSIONIn the cervical spine, transpedicular fixation using an aiming device can improve the accuracy and safety during operation.

Adult ; Bone Screws ; Cervical Vertebrae ; diagnostic imaging ; surgery ; Female ; Humans ; Internal Fixators ; Male ; Orthopedic Fixation Devices ; Spinal Fusion ; instrumentation ; methods ; standards ; Stereotaxic Techniques ; Therapy, Computer-Assisted ; Tomography, X-Ray Computed

Lumbar spinal fusions have been performed for spinal stability, pain relief and improved function in spinal stenosis, scoliosis, spinal fractures, infectious conditions and other lumbar spinal problems. The success of lumbar spinal fusion depends on multifactors, such as types of bone graft materials, levels and numbers of fusion, spinal instrumentation, electrical stimulation, smoking and some drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs). From January 2000 to December 2001, 88 consecutive patients, who were diagnosed with spinal stenosis or spondylolisthesis, were retrospectively enrolled in this study. One surgeon performed all 88 posterolateral spinal fusions with instrumentation and autoiliac bone graft. The patients were divided into two groups. The first group (n=30) was infused with ketorolac and fentanyl intravenously via patient controlled analgesia (PCA) postoperatively and the second group (n=58) was infused only with fentanyl. The spinal fusion rates and clinical outcomes of the two groups were compared. The incidence of incomplete union or nonunion was much higher in the ketorolac group, and the relative risk was approximately 6 times higher than control group (odds ratio: 5.64). The clinical outcomes, which were checked at least 1 year after surgery, showed strong correlations with the spinal fusion status. The control group (93.1%) showed significantly better clinical results than the ketorolac group (77.6%). Smoking had no effect on the spinal fusion outcome in this study. Even though the use of ketorolac after spinal fusion can reduce the need for morphine, thereby decreasing morphine related complications, ketorolac used via PCA at the immediate postoperative state inhibits spinal fusion resulting in a poorer clinical outcome. Therefore, NSAIDs such as ketorolac, should be avoided after posterolateral spinal fusion.
Adult ; Aged ; *Analgesia, Patient-Controlled ; Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/*adverse ; Case-Control Studies ; Drug Therapy, Combination ; Female ; Fentanyl/administration & dosage/therapeutic use ; Humans ; Injections, Intravenous ; Ketorolac/*administration & dosage/*adverse effects/therapeutic use ; Male ; Middle Aged ; Postoperative Care/*adverse effects ; Research Support, Non-U.S. Gov't ; Retrospective Studies ; *Spinal Fusion/standards ; Treatment Outcome