Rationale, study design, and descriptive data of the Lucky Bone™ Fracture Liaison Service.

The study design of a multidisciplinary Fracture Liaison Service (2-year follow-up) aiming to optimize fragility fracture management in an outpatient setting is presented. Patient characteristics, investigation, and treatment initiation data at baseline were recorded. Results corroborate the care gap in osteoporosis management, reinforcing the need for secondary fracture prevention programs. PURPOSE: This paper describes the study design, implementation, and baseline characteristics of a multidisciplinary Fracture Liaison Service (FLS) in Quebec (Canada). METHODS: A FLS was implemented as a prospective cohort study. After identification, fracture risk was assessed and patients were started on treatment or referred, according to guidelines and risk assessment. Thereafter, patients were systematically followed over 2 years. Clinical data (fractures, bone density, blood testing (bone turnover markers), quality of life, physical disability) as well as administrative data (pharmacological, health services, hospitalization) was collected. Baseline descriptive data was analyzed and presented. RESULTS: Of 542 recruited participants, 532 underwent baseline assessment (85.7% female, mean age 63.4 years). Overall, 29.7% of participants either withdrew from the study or were lost to follow-up. Almost 27% were referred to a specialist, while > 70% received anti-osteoporosis medication prescriptions through the FLS at baseline. Mean femoral T-score was - 1.6 ± 1.0 and vertebral T-score was - 1.7 ± 1.4. Nearly 19% of subjects reported being under anti-osteoporosis medication at the time of incident fracture. Thirty-three percent of participants reported a prior fracture history, of which 29.7% reported being given anti-osteoporosis therapy. Most fracture sites were to the wrist and ankle, while < 19% were hip/femur or vertebral fractures. CONCLUSIONS: These results highlight the important care gap in fragility fracture management and reinforce the need for secondary fracture prevention programs. This prospective study will allow the evaluation of key performance indicators for outpatient clinic-based FLS, such as medication usage, by combining prospective clinical and administrative data.

Early Impact of Postoperative Bracing on Pain and Quality of Life After Posterior Instrumented Fusion for Lumbar Degenerative Conditions: A Randomized Trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVE: To investigate whether bracing after posterior spinal instrumented fusion (PSIF) can improve pain relief and quality of life (QoL) 6 weeks and 3 months postoperatively. SUMMARY OF BACKGROUND DATA: Braces are commonly prescribed after PSIF in patients with lumbar degenerative conditions with the aim of improving pain relief and QoL. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons use braces mainly based on their experience and training. METHODS: A randomized blinded and controlled trial of 43 patients with PSIF for lumbar degenerative conditions were recruited. The caregivers were blinded but not the orthotist in the present study. There were 25 patients in the brace group and 18 patients in the control group with similar baseline characteristics. All patients completed the Oswestry Disability Index (ODI), the short form (SF)-12v2 General Health Survey and Visual Analog Scale (VAS) for back pain preoperatively, at 6 weeks and 3 months follow-up. Wilcoxon-Mann-Whitney test and a level of significance of 0.05 were used for statistical analyses. RESULTS: Both groups had comparable demographic characteristics, and preoperative SF-12v2, ODI, and VAS scores. The ODI, SF-12v2, and VAS for back pain were improved in comparison to preoperative scores. The improvement was significant at 3 months follow-up regarding ODI and VAS for both groups and significant only for the control group regarding SF-12v2 scores. The improvement in ODI, SF-12v2, and VAS was significantly greater for control group at 3 months postoperatively. Moreover, larger proportion of patients in the control group reached minimum clinically important difference as compared to brace group at 6 weeks and 3 months. CONCLUSION: Postoperative bracing did not result in better improvement in QoL or pain relief up to 3 months after PSIF in patients with lumbar degenerative conditions. LEVEL OF EVIDENCE: 1.

rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

STUDY DESIGN: Multicenter randomized controlled trial. OBJECTIVE: To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. SUMMARY OF BACKGROUND DATA: In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. METHODS: Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. RESULTS: One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). CONCLUSION: The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

Treatment of thoracolumbar burst fractures by means of anterior fusion and cage.

STUDY DESIGN: Retrospective case series. OBJECTIVE: To evaluate the outcome of treating acute thoracolumbar burst fractures using anterior corpectomy and reconstruction with a mesh cage and instrumentation. SUMMARY OF BACKGROUND DATA: There is increasing interest in using an anterior mesh cage with instrumentation after corpectomy for burst fractures. However, there is only limited information on this technique in the literature. METHODS: Twenty-two patients (mean age 37.6 y old) that had sustained a thoracolumbar burst fracture were included in this study. On admission, 20 patients (90.9%) had an incomplete neurological deficit. An anterior thoracolumbar approach was used to perform anterior corpectomy and reconstruction with a mesh cage and lateral fixation with screws and dual rods. We studied the operation date and delayed the blood loss, and we used the American Spinal Injury Association grade to evaluate the neurological status before surgery and in the follow-up period. Local kyphosis measured by the Cobb method was compared before and after the surgery using Wilcoxon signed-rank test/2-tailed test for analysis. RESULTS: Ninety percent of patients were operated within 2 days after admission and all were followed for a minimum of 25 months. The mean follow-up period was 47.4 months (range, 25 to 71 mo). Blood loss averaged 1445 mL. Of the 20 patients with incomplete neurological lesions, there were 6 (30%) patients with an improvement of at least 1 American Spinal Injury Association grade. No neurological deterioration was observed in any case. The local kyphosis measured by the Cobb method was improved from a mean of 15 degrees preoperative to a mean of 9.6 degrees in early postoperative period (P=0.002). The mean after 2 years was 11.5 degrees (P=0.011). There was no instrumentation failure. CONCLUSIONS: Anterior thoracolumbar decompression and fusion secured with an anterior mesh cage and instrumentation in thoracolumbar burst fractures provided excellent immediate reduction of post-traumatic local kyphosis.

Posterior pedicle screw fixation with supplemental laminar hook fixation for the treatment of thoracolumbar burst fractures.

Surgical treatment of thoracolumbar burst fractures with posterior short-segment pedicle fixation usually provides excellent initial correction of kyphotic deformity, but a significant amount of correction can be lost afterwards. This study evaluates the clinical relevance of the short-segment pedicle fixation supplemented by laminar hooks (2HS-1SH) construct in the surgical treatment of thoracolumbar burst fractures. Twenty-five patients with a single-level thoracolumbar burst fracture were assessed in this retrospective study. All patients were followed for a minimum of 1 year (mean 2.9 [standard deviation {SD}] 1.5 y). Preoperative vertebral height loss and local kyphosis were 35% (SD 14%) and 19 degrees (SD 9 degrees ), respectively. Mean corrections of vertebral height and kyphosis were 10% (SD 16%) and 12 degrees (SD 9 degrees ), respectively. Mean loss of correction at last follow-up was 2% (SD 6%) and 4 degrees (SD 3 degrees ) for vertebral height and kyphosis, respectively. Loss of correction was significant for local kyphosis (p 0.001) but not for vertebral height (p = 0.20). Despite the significant loss of correction for local kyphosis, it remained improved at latest follow-up when compared with the preoperative value (p 0.001). For patients with more than 2 years of follow-up, most of the loss of correction in local kyphosis occurred during the first postoperative year. There was no evidence of instrumentation failure or pseudarthrosis in any patient. The 2HS-1SH construct provides significant correction of vertebral body height and local kyphosis. It also preserves the initial correction and minimizes the risk of instrumentation failure.

Assessment of sacral doming in lumbosacral spondylolisthesis.

STUDY DESIGN: Quantitative versus subjective evaluation of sacral doming in lumbosacral spondylolisthesis. OBJECTIVES: To evaluate the relevance of the Spinal Deformity Study Group (SDSG) index in the assessment of sacral doming and to propose a quantitative criterion to differentiate between significant and nonsignificant doming. SUMMARY OF BACKGROUND DATA: There is no consensus on the optimal technique to assess sacral doming, although it is an important feature in spondylolisthesis. METHODS: Five spinal surgeons subjectively assessed the sacral endplate of 100 subjects (34 high-grade spondylolisthesis, 50 low-grade spondylolisthesis, 16 controls) from lateral radiographs. Subjects were classified by each surgeon as having significant or nonsignificant sacral doming. An independent observer quantitatively evaluated sacral doming for all subjects using the SDSG index. A criterion to differentiate significant from nonsignificant sacral doming was sought, based on the comparison between the subjective assessment of surgeons and the quantitative evaluation by the independent observer. Intrarater and interrater reliability of the SDSG index was evaluated using intraclass correlation coefficient (ICC). RESULTS: Intrarater and interrater ICCs for the SDSG index were excellent at 0.91 and 0.88, respectively. Sacral doming evaluated with the SDSG index was 11.6% +/- 5.0% (range, 1.5%-18.9%), 16.4% +/- 6.3% (range, 3.7%-35.6%), and 27.9% +/- 10.9% (range, 5.7%-56.9%) for controls, low-grade, and high-grade cases, respectively. Overall intersurgeon agreement on the significance of sacral doming was substantial at 88% (kappa = 0.72). With a threshold value of 25% for the SDSG index, 93% of concordance was found between the quantitative evaluation using the SDSG index and the multisurgeons subjective assessment. CONCLUSION: This study confirms the relevance of the SDSG index to assess sacral doming in lumbosacral spondylolisthesis. The authors propose a criterion of 25% to differentiate significant from nonsignificant sacral doming using the SDSG index. Such a criterion will allow more accurate assessment of sacral remodeling, especially for borderline cases, and facilitate comparisons between studies.