Dalteparin versus enoxaparin for venous thromboembolism prophylaxis in acute spinal cord injury and major orthopedic trauma patients: 'DETECT' trial.

BACKGROUND: To compare the impact of switching from enoxaparin 30 mg subcutaneously (SC) twice daily to dalteparin 5,000 units SC once daily for venous thromboembolism (VTE) prophylaxis in critically-ill major orthopedic trauma and/or acute spinal cord injury (SCI) patients. METHODS: DETECT was a retrospective, cohort study at a tertiary care referral teaching center-phase 1 from December 1, 2002 to November 30, 2003 (enoxaparin); and phase 2 from January 1, 2004 to December 31, 2004 (dalteparin). Major orthopedic trauma patients with pelvic, femoral shaft, or complex lower extremity fractures, and/or acute SCI patients admitted to the intensive care unit and who received a low-molecular-weight heparin (LMWH) for VTE prophylaxis were included. RESULTS: DETECT reviewed 135 patients (63 enoxaparin, 72 dalteparin), with similar baseline demographics, clinical characteristics, injuries, severity of illness, and risk factors for VTE. Clinically symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) rates were 1.6% with enoxaparin and 9.7% with dalteparin (p=0.103, absolute risk increase [ARI] of 8.1% [-0.6% to 15.6%]), with no differences in major bleeding (6.4% versus 6.9%) or minor bleeding (64% versus 69%), or mortality (4.8% versus 6.9%). Switching from enoxaparin to dalteparin was associated with $12,485 (CAD) in LMWH acquisition cost savings. CONCLUSIONS: DETECT raises the hypothesis that dalteparin 5,000 units SC daily may not be clinically noninferior to enoxaparin 30 mg SC twice daily for VTE prophylaxis in this high-risk population. Until an adequately-powered, prospective noninferiority trial is performed, enoxaparin is supported by level 1 evidence and should be the prophylactic agent of choice.

Impact of surgical intervention on quality of life in patients with spinal metastases.

STUDY DESIGN: Prospective clinical study. OBJECTIVE: To assess Health-Related Quality of Life outcomes in patients undergoing surgery for spinal metastases. SUMMARY OF BACKGROUND DATA: Increasing life expectancy of patients with spinal metastases has resulted in greater interest in overall quality of life, including pain and neurologic impairment. To assess the overall risks and benefits of surgical intervention, the overall impact of each on the overall health status must be assessed. METHODS: All patients who presented to a single institution with bony spinal metastases requiring surgical intervention were eligible. EXCLUSION CRITERIA: previous surgery for spinal metastases, primary tumors of the spine, and inability to fill out the questionnaires. Patients completed an EORTC QLQ-C30, the HUI-3, the EQ-5D, visual analog pain, and an ECOG functional assessment. at five points: before surgery and at 6 weeks, 3 months, 6 months, and 1 year post surgery. RESULTS: Of 96 patients who presented to the hospital, 85 were enrolled in the study. Average age was 58.6 years (range, 20.3-80.7 years) with 47 male patients; 50% survival as 39.1 weeks. Maximal and average VAS pain levels showed a statistically significant (P < 0.00001) improvement from preoperative to all postoperative time points. Only the QLQ-C30 global health status showed a statistically significant improvement from preoperative to the 6-week (P = 0.017), 3-month (P = 0.039), and 6-month (P = 0.013) time points. There was a statistically significant correlation between baseline global health status and survival time (P = 0.041). Overall distribution of HUI-3 utility calculated Quality of Life Adjusted Years (QALY) during the 1-year postoperative period showed a bimodal distribution with peaks at 0.1 and 0.7 years. CONCLUSIONS: Surgery for patients with spinal metastases offers decreased pain and improved quality of life with low rates of surgical complications.

Knowledge transfer in family physicians managing patients with acute low back pain: a prospective randomized control trial.

BACKGROUND CONTEXT: The process through which new scientific developments are incorporated into clinical practice is referred to as "knowledge transfer" and is currently the subject of great interest in many areas of clinical medicine. Family physicians managing patients with acute low back pain have been shown to have a poor overall rate of concordance with clinical practice guideline-recommended treatments. New methods need to be developed to help physicians bridge the guideline implementation gap. PURPOSE: To determine the efficacy of a knowledge transfer method that communicates clinical practice guidelines to family physicians and their patients using patient-specific, physician-to-physician communications. STUDY DESIGN: A prospective randomized controlled study. PATIENT SAMPLE: 428 patients with acute mechanical low back pain and accepted Workers' Compensation Board claims were studied. OUTCOME MEASURES: Concordance with specific clinical practice guideline-derived history taking items, physical examination procedures and treatment recommendations was determined. METHODS: Patients with acute mechanical back pain of less than 4 weeks duration and accepted Workers' Compensation Board claims were randomly assigned to one of three groups. In Group 1 (control group) neither the patients nor their family physicians received any information concerning the guidelines. In Group 2, family physicians alone or as well as their patients (Group 3) received a summary of clinical practice guidelines at approximately 2 weeks postinjury. In addition, both Groups 2 and 3 received reminders summarizing the recommended guidelines for patients at three specific stages of their clinical course. All guideline correspondence was addressed to a specific family physician or patient, signed by the study physician-investigators, and specified the patient by name. RESULTS: Family physicians in the control and intervention groups demonstrated a high degree of concordance with the guideline-recommended history taking and physical examination procedures, but were generally highly discordant with guideline-recommended treatments. Significant improvement in guideline-concordant treatments was seen only with diminished recommendations of prolonged bed rest and passive therapies and an increase in recommended aerobic exercise. Concordance with guideline recommendations relating to the use of spinal manipulative therapy was poor in all study groups. CONCLUSIONS: A knowledge transfer method that involved patient-specific, physician-to-physician communication to family physicians or their patients at three stages of the patient's clinical course was largely unsuccessful in improving concordance with guideline treatment recommendations.

Motor recovery, functional status, and health-related quality of life in patients with complete spinal cord injuries.

STUDY DESIGN: A retrospective cohort with cross- sectional follow-up. OBJECTIVES: The primary objective was to determine motor recovery in patients with complete traumatic spinal cord injury (SCI). Secondary objectives included: 1) determining which factors predict local recovery, 2) assessing functional status using the Functional Independence Measure (FIM), and 3) assessing generic health-related quality of life using the Short Form-36 (SF-36). SUMMARY OF BACKGROUND DATA: Motor recovery following complete SCI has been documented in the literature; however, it has been difficult to interpret: 1) spinal shock is often not addressed; 2) the definition of complete SCI has changed over the last 10 years; and 3) few studies differentiate between local neurologic recovery in the zone of partial preservation and neurologic recovery caudal to the lesion. METHODS: All patients admitted to Vancouver Hospital with a complete SCI between 1994 and 2001 were identified and included in the study if they remained complete following the resolution of spinal shock. Minimum 2-year follow-up consisted of an ASIA motor score, an FIM, and the SF-36. RESULTS: Of 133 patients identified, 94 were eligible and 70 completed follow-up. For the tetraplegic patients, the average ASIA motor score was 11.9 +/- 10.7 on admission and 20.1 +/- 10.8 at follow-up, a change reflecting local recovery only. For the paraplegic patients, the average ASIA motor score was 49.3 +/- 2.4 on admission and 50.6 +/- 1.7 at follow-up. CONCLUSIONS: Motor recovery does not occur below the zone of injury for patients with complete SCI. Varying degrees of local recovery can be expected in tetraplegic individuals.

Factors predicting motor recovery and functional outcome after traumatic central cord syndrome: a long-term follow-up.

STUDY DESIGN: A prospectively maintained database-generated retrospective review and cross-sectional outcome analysis was performed at a single academic center. OBJECTIVES: To assess the improvement in ASIA motor score (AMS) and secondarily to assess generic health related quality of life (HRQoL) and functional status; correlating these with variables that may predict outcome. SUMMARY OF BACKGROUND DATA: Many variables are potential contributors to motor recovery, patient function, and outcome following cervical trauma. Studies often suffer from low power, short follow-up, heterogeneous cohorts, and use of outcome instruments that are neither valid nor psychometrically sound. METHODS: AMS were collected within 72 hours of the time of injury and again at follow-up by trained examiners. The SF-36 and FIM were administered to all patients at follow-up. RESULTS: AMS improved from a mean of 58.7 at injury to a mean of 92.3 at follow-up. Bowel and bladder continence was reported by 81% while independent ambulation was reported by 86%. Final AMS was positively correlated with the AMS at injury, formal education, and presence of spasticity at follow-up. Functional status (FIM) was positively correlated with higher AMS at injury, formal education, absence of comorbidities, absence of spasticity, and younger age. Generic HRQoL outcomes (SF-36) were improved in individuals with more formal education, fewer comorbidities, absence of spasticity, and anterior column fractures. CONCLUSIONS: Although the majority of patients improve to an AMS between 90 and 100, many have significant disability and are less functional than the general population. Significant predictive variables include the initial motor score, formal education, comorbidities, age at injury, and development of spasticity. An assessment of more than just the motor score is required to obtain an appreciation of the function and outcomes in this population.

Early versus late enteral feeding in patients with acute cervical spinal cord injury: a pilot study.

STUDY DESIGN: A prospective randomized clinical pilot study to compare early versus late enteral feeding in patients with acute cervical spinal cord injury. OBJECTIVES: To compare the incidence of infections in patients with acute cervical spinal cord injury who received early versus late enteral feeding. Secondary objectives included assessing nutritional status, feeding tolerance, the number of ventilator hours, and acute-care hospital length of stay. SUMMARY OF BACKGROUND DATA: Early nutritional support has been found to be beneficial in critically ill patients. However, the same benefits may not be realized in patients with acute cervical spinal cord injury because of their unique nutritional challenges. METHODS: Eligible patients were randomized to early feeding (initiated before 72 hours after injury) and late (initiated more than 120 hours after injury). Patients were stratified on the basis of their neurologic level. Patients were assessed daily for the first 15 days. After that time, infections (according to Center for Disease Control criteria), ventilator hours, and length of acute-care hospital stay were tracked. RESULTS: Twenty-three patients met the eligibility criteria, and 17 patients were included in the analysis. There were 7 patients in the early group and 10 in the late group. The early group had a mean of 2.4 +/- 1.5 infections compared with the late group, which had a mean of 1.7 +/- 1.1 infections. Secondary outcomes were not substantially different between the two groups. CONCLUSIONS: This pilot study failed to detect any differences in the incidence of infection, nutritional status, feeding complications, number of ventilator hours, or length of stay between patients receiving early versus late initiation of enteral feeding. These data will assist in the determination of an adequate sample size for future studies.

Compliance with clinical practice guidelines in family physicians managing worker's compensation board patients with acute lower back pain.

BACKGROUND CONTEXT: Family physician compliance with acute lower back pain clinical practice guidelines remains uncertain. PURPOSE: To determine the degree of guideline compliance of family physicians managing patients with workers' compensation claims and acute mechanical lower back pain. STUDY DESIGN: Observational study. PATIENT SAMPLE: One hundred thirty-nine family physicians in British Columbia. OUTCOME MEASURES: Compliance with guideline recommendations for history, examination procedures, diagnostic testing and treatments. METHODS: Physician workers' compensation board patient reports for acute lower back pain without leg symptoms and not greater than 2 to 3 weeks duration were scored for guideline adherence up until 12 weeks after onset. RESULTS: Physicians demonstrated a high degree of compliance with the guideline-recommended history, examination procedures and medications, but low compliance with recommended imaging and many treatment recommendations. CONCLUSIONS: Recently published clinical practice guidelines regarding the management of patients with acute mechanical lower back pain have not been fully implemented into the patterns of practice of the family physicians.

Effectiveness of titanium mesh cylindrical cages in anterior column reconstruction after thoracic and lumbar vertebral body resection.

STUDY DESIGN: A retrospective cohort study with cross-sectional outcome analysis of patients who underwent anterior column reconstruction with a titanium mesh cage after single-level or multilevel thoracic or lumbar vertebrectomy. OBJECTIVES: To radiographically evaluate the ability of titanium mesh cages to maintain alignment and facilitate osseous fusion after thoracolumbar vertebrectomy. Secondary objectives assessed complications and patient outcome. SUMMARY OF BACKGROUND DATA: Titanium mesh cages with cancellous autograft bone for postvertebrectomy reconstruction of the thoracolumbar spine avoid some of the potential problems associated with the acquisition or use of structural autograft or allograft. There is little in the literature that describes the efficacy or outcomes of using cylindrical mesh titanium cages for postvertebrectomy reconstruction. METHODS: The degree of kyphosis and the subsidence of the cage in relation to the vertebral endplates were measured in 43 of 57 (75%) patients available at a minimum of 2 years following titanium mesh cage reconstruction. Health-related quality of life and disability were assessed with various cross-sectional outcome measures. RESULTS: The average kyphosis of 25.4 degrees before surgery was reduced to 7.5 degrees immediately after surgery, and at final follow-up was measured to be 10.4 degrees. Cage subsidence averaged 0.28 and 0.20 cage fenestrations at the cephalad and caudal endplates, respectively. Osseous union (Grade 1 or 2) was identified in 93% of radiographs at the final follow-up. Thoracic reconstructions were significantly more likely to require surgical revision because of mechanical failure than thoracolumbar or lumbar reconstructions. CONCLUSION: The cylindrical mesh titanium cage is a successful adjunct in restoring and maintaining sagittal plane alignment after thoracolumbar vertebrectomy and, in this context, provides an effective method for anterior column reconstruction.

Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion.

STUDY DESIGN: A prospective, randomized, double-blind clinical trial was conducted. OBJECTIVE: To compare the efficacy of patient-controlled analgesia (PCA) with that of patient-controlled epidural analgesia (PCEA) in terms of overall patient satisfaction with postoperative pain management after lumbar spine fusion. SUMMARY OF BACKGROUND DATA: In numerous surgical disciplines, PCEA and PCA have proved to be effective methods of postoperative pain control. The literature states that with PCEA, less opioid use is required during the immediate postoperative period to maintain equivalent pain control compared to PCA. Continuous epidural infusion has been assessed in spine fusion patients, but PCEA has not been evaluated. Furthermore, this is the first prospective randomized clinical trial to assess overall patient satisfaction while stratifying patients for both anxiety level and preoperative opioid use. METHODS: For this study, 74 patients were assigned randomly to one of two treatment groups, with PCA and PCEA administered in a double-blind manner for a 3-day postoperative course. All the patients received both PCA and PCEA delivery systems. Assessment was by a blinded, independent observer. Overall patient satisfaction with pain management was assessed by a visual analog scale at the end of postoperative day 3. Secondary measures included: three scales from the Functional Independence Measure instrument; opioid quantity; side effects; and length of hospital stay. RESULTS: Thirty-eight patients were randomized to PCA, and 36 were randomized to PCEA. No baseline variable differences between the groups were observed. The results showed no difference between the groups on the following measures: overall patient satisfaction with pain management, ambulation, and length of stay. The PCA patients used significantly more opioid than the PCEA patients. CONCLUSIONS: Both postoperative analgesic regimens provided good overall patient satisfaction. The only clinical advantage of PCEA over PCA for spine fusion patients was the lower amount of opioid consumed, although the PCEA group experienced significantly more side effects than the PCA group. There were no other significant differences. Therefore, patient or physician preference could select either postoperative pain management delivery system.

Comparison of outcomes for unstable lower cervical flexion teardrop fractures managed with halo thoracic vest versus anterior corpectomy and plating.

STUDY DESIGN: A retrospective cohort study with cross-sectional outcome analysis was conducted. OBJECTIVES: To compare the outcome for two groups of patients with unstable cervical flexion teardrop fractures: those treated with halo thoracic vests and those treated with anterior corpectomy and plating. SUMMARY OF BACKGROUND DATA: With the evolution of safe and effective anterior cervical plates, the treatment of unstable cervical flexion teardrop fractures has shifted from halo immobilization to surgical stabilization. Although outcomes for these treatment alternatives have been reported, the literature reflects the inherent bias of retrospective studies without standardized health-related quality-of-life outcomes and without a control or comparative group. Furthermore, study populations have lacked homogeneity with respect to fracture patterns. METHODS: For this study, 45 patients with cervical flexion teardrop fractures and at least 2 years of follow-up evaluation were identified. Of these patients, 24 were treated with a halo thoracic vest and 21 with anterior corpectomy and plating. Unstable cervical flexion teardrop fractures were defined as those exhibiting failure of the anterior spine under compression and the posterior spine in tension. The primary outcome was radiographic kyphosis at follow-up assessment. Secondary outcomes included the MOS 36-Item Short-Form Health Survey and the Cervical Spine Research Society Long-Term Follow-Up questionnaire. RESULTS: The halo thoracic vest group and the anterior corpectomy and plating group were comparable for baseline demographic and clinical data, except for neurologic deficit (67% of the halo thoracic vest group and 96% of the anterior corpectomy and plating group had neurologic deficit). Most of the injuries occurred at C5. All 45 patients had radiographic follow-up evaluation, but only 17 of the 24 patients in the halo thoracic vest group and 13 of the 21 patients in the anterior corpectomy and plating group (30 of 45 in all) completed the health-related quality-of-life outcome instruments. The mean kyphosis was 11.4 degrees in the halo thoracic vest group and 3.5 degrees in the anterior corpectomy and plating group (P < 0.001). The difference remained significant, with control used for the baseline variables. The halo thoracic vest group had five failures, four of which were subsequently managed operatively. No major intra- or postoperative complications occurred in the anterior corpectomy and plating group. There were no significant differences in the MOS 36-Item Short-Form Health Survey mental component score and the Cervical Spine Research Society subscales even after adjustment for neurologic deficit. CONCLUSIONS: The results of this study indicate that anterior cervical plating is a safe and effective treatment for cervical teardrop fractures, and that it is superior to the halo thoracic vest for restoring and maintaining sagittal alignment and for minimizing treatment failures. There does not appear to be a relation between residual kyphosis and health-related quality-of-life outcomes. Although this raises questions about the relevance of restoring sagittal alignment in the treatment and outcome of cervical flexion teardrop fractures, the study was underpowered for secondary outcomes. Therefore, the secondary outcome results must be interpreted with caution.