Stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis.

OBJECTIVE: To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis. METHODS: Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months. RESULTS: Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs. 52%), leg pain (70% vs. 62%), ODI (51% vs. 47%) and ZCQ symptom severity (37% vs. 29%) and physical function (36% vs. 32%). CONCLUSION: Both treatments provide effective and durable symptom relief of claudicant symptoms. This stand-alone interspinous spacer offers the patient a minimally invasive option with less surgical risk.

Immunogenicity and safety of re-exposure to recombinant human thrombin in surgical hemostasis.

BACKGROUND: This Phase 4, open-label study evaluated the immunogenicity and safety of a second exposure to recombinant human thrombin (rThrombin) in adult patients with previous exposure to rThrombin. STUDY DESIGN: Topical rThrombin was applied as a hemostatic aid during a surgical procedure (day 1). Adverse events and clinical laboratory abnormalities were monitored to day 29 (study end). Immunogenicity samples were collected on days 1 and 29. Thirty-one patients were treated at 9 study sites; 30 patients completed the study. RESULTS: Mean age was 59.5 years; 61.3% of patients were male. Study operations types included spinal (n = 23 of 31; 74.2%), arterial reconstruction or peripheral arterial bypass (n = 4; 12.9%), arteriovenous vascular access procedure (n = 3; 9.7%), and other (n = 1; 3.2%). A median of 10 mL rThrombin (1,000 IU/mL; range 5 to 60 mL) was prepared per patient. Median elapsed time since previous rThrombin exposure was 1.3 years (range 19 days to 3.3 years). Recombinant human thrombin was not observed to be immunogenic; no patients (n = 0 of 30, 0%; 95% CI 0.0%, 11.6%) became positive for anti-rThrombin product antibodies at day 29, approximately 1 month after the second exposure to rThrombin. The most commonly reported adverse events were procedural pain (n = 23 of 31, 74.2%), constipation (n = 8, 25.8%), and nausea (n = 8, 25.8%) All adverse events and clinical laboratory abnormalities were considered unrelated to treatment. For the majority of patients, maximal severity of any adverse event was mild or moderate. CONCLUSIONS: The immunogenicity and safety results of this Phase 4 rThrombin trial suggest that patients with known previous exposure may be safely re-exposed to topical rThrombin.

Atraumatic odontoid fractures in patients with rheumatoid arthritis.

BACKGROUND CONTEXT: Instability of the cervical spine is a common problem in patients with rheumatoid arthritis. The natural course of rheumatoid arthritis in the cervical spine is well documented. However, the true prevalence of occult fractures of the odontoid process in patients with rheumatoid arthritis is not known. PURPOSE: To draw attention to the possibility of occult, atraumatic fractures of the odontoid process in patients with rheumatoid arthritis. STUDY DESIGN: We report on two cases with previously unrecognized fractures of the odontoid process. METHODS: In this case series, we review the individual radiographic findings and clinical observations in two rheumatoid patients in whom a fracture of the odontoid process was diagnosed. RESULTS: Each one of these two rheumatoid patients had an unrecognized fracture of the odontoid process without any prior history of trauma. Their fracture was identified serendipitously during workup for neck pain. CONCLUSIONS: Occult, atraumatic fractures of the odontoid process may be found in patients with long-standing rheumatoid arthritis. This injury should be suspected if previously asymptomatic patients complain about new onset of neck pain without significant trauma.

Three-level bilateral pediculolysis following osteoporotic lumbar compression fracture.

BACKGROUND CONTEXT: Osteoporotic compression fractures frequently occur at the thoracolumbar junction as a result of anterior column failure. Fractures of the pedicles are much less common and are not known to be associated with a prior compression fracture. Bilateral pedicle fractures over several consecutive lumbar levels in an osteoporotic elderly patient have not been previously reported. PURPOSE: To draw attention to this unusual case and to review the relevant literature. STUDY DESIGN: A clinical case report of bilateral fractures of the pedicles from L3 through L5 in an 83-year-old male 2 years after an osteoporotic L3 compression fracture presenting with low back pain. METHODS: An 83-year-old male presented with low back pain two years after sustaining osteoporotic compression fracture at L3 due to a fall. He had another minor fall and his radiographic workup revealed bilateral fractures of the pedicles of the L3, L4, and L5 vertebrae. The patient was treated nonoperatively. RESULTS: The patient's symptoms improved without surgical intervention. Subsequent radiographic evaluation with plain films, computed tomography, and bone scan demonstrated union of the fractured pedicles. CONCLUSIONS: In this uncommon case of bilateral lumbar pedicle fractures over three consecutive levels, isolated failure of the posterior rather than the anterior column occurred. This unusual fracture pattern may have been precipitated by the previous vertebral compression fracture. Nonsurgical management may result in acceptable clinical outcome.