A functional brace for treating Colles fractures; volunteer trial of a new design.

BACKGROUND: Presently used Colles' fracture treatments have similar outcomes with significant complications. Previous studies of a dynamic functional fracture brace, achieving similar or better results had no significant complications. A novel brace design is described to achieve optimal patient outcomes. METHODS: Patient forearm measurements combined with data from a previously tested brace provided parameters for a brace formed using computer assisted design. Fracture swelling was simulated using a 40 ml (ml) plastic water filled bag placed over the dorsum of the lower radius. The interface pressure between the brace, skin and bag were measured on twelve human volunteers, four with forearm measurements to fit each of small, medium and large brace sizes. Measurements were taken at intervals reducing volume of fluid in the bag by 10 ml until empty, first wearing a brace, and then with a Colles plaster of Paris cast. FINDINGS: The brace produced interface pressures over the lower radius in the range of 62.5-90 (mm Hg) and when the bag was completely empty the pressure range was 43-83 mmHg. The initial interface pressures in the Colles casts were in the range of 15-18 mm of Mercury (mm Hg) and when 10 mls were removed from the plastic bag the interface pressure dropped immediately to almost zero. INTERPRETATION: The brace measurements show pressures higher than a Colles cast which compensate for reduction of simulated swelling. It is safe and is potentially the optimal design to achieve significantly improved patient outcomes.

Sciatica caused by disc herniation: Why is Chymopapain Chemonucleolysis denied to our patients?

BACKGROUND: This study was undertaken to assess the long term outcome on the quality of life of patients with sciatica following treatment with chemonucleolysis, and to assess the complications. METHODS: This is a retrospective review carried out in a consecutive group of patients suffering from sciatica treated by chemonucleolysis. Patients were followed up by questionnaires to obtain Macnab score; satisfaction, SF 36, and case note review for complications and repeat spinal surgery. RESULTS: Six hundred and five patients (56% males, 44% females) treated over a ten year period from 1991 to 2000 were followed up. Average age was 47 years (range 17 - 88 years). The duration of symptoms prior to treatment averaged 10 months (range 1 - 20 months) and the herniation was confirmed by Myelogram (7%), CT Scan (34%), or MRI (59%). There were 578 single level and 27 double levels treated. Eighty five percent of herniations were typical single level, and 15% were atypical that is: patients with dominant back pain with sciatica, recurrent herniations following surgery at the same level, recurrent herniations at another level following chemonucleolysis, double levels treated patients with mainly neurological deficits and one cauda equina syndrome. Average follow up was 62 months (range 12 - 123) with a 78% satisfaction rate, with a 14% surgical intervention rate made up of 9% decompression, 1% repeat chemonucleolysis at another level and 4% fusion rate. SF-36 scores generally correlated with age and sex on scores for the normal local population. CONCLUSIONS: This is a retrospective study and showed that chemonucleolysis was effective with a high satisfaction rate. It restores quality of life close to that expected in the population, and is safe with no complications related to the procedure. It is a cost effective daycase procedure with a lasting result.

Measurement of lumbar spine intervertebral motion in the sagittal plane using videofluoroscopy.

BACKGROUND: Static radiographic techniques are unable to capture the wealth of kinematic information available from lumbar spine sagittal plane motion. OBJECTIVE: Demonstration of a viable non-invasive technique for acquiring and quantifying intervertebral motion of the lumbar spine in the sagittal plane. METHODS: Videofluoroscopic footage of sagittal plane lumbar spine flexion-extension in seven symptomatic volunteers (mean age = 48 yrs) and one asymptomatic volunteer (age = 54 yrs) was recorded. Vertebral bodies were digitised using customised software employing a novel vertebral digitisation scheme that was minimally affected by out-of-plane motion. RESULTS: Measurement errors in intervertebral rotation (± 1°) and intervertebral displacement (± 0.5 mm) compare favourably with the work of others. Some subjects presenting with an identical condition (disc prolapse) exhibited a similar column vertebral flexion-extension relative to S1 (L3: max. 5.9°, min. 5.6°), while in others (degenerative disc disease) there was paradoxically a significant variation in this measurement (L3: max. 28.1°, min. 0.7°). CONCLUSIONS: By means of a novel vertebral digitisation scheme and customised digitisation/analysis software, sagittal plane intervertebral motion data of the lumbar spine data has been successfully extracted from videofluoroscopic image sequences. Whilst the intervertebral motion signatures of subjects in this study differed significantly, the available sample size precluded the inference of any clinical trends.

Prospective randomized trial of chemonucleolysis compared with surgery for soft disc herniation with 1-year, intermediate, and long-term outcome: part II: the radiological outcome.

STUDY DESIGN: A prospective consecutive series of 100 patients computer randomized into 2 groups to have treatment by either chemonucleolysis or surgery. OBJECTIVE: To compare the radiological findings preoperatively with the clinical outcome between the groups at 1 year, 10 to 13, and 24 to 27 years of follow-up. SUMMARY OF BACKGROUND DATA: Chemonucleolysis was introduced in 1964 and became widely used. Its efficacy was proven by several randomized studies when compared with a placebo and surgery. However, it ceased to be manufactured in 2001. METHODS: One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. Preoperatively, their anteroposterior, lateral lumbar spine, and lateral lumbosacral angle radiographs were obtained, and a myelogram was performed. At 10 to 13 years, 32 of the original patients (18 chemonucleolysis and 14 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were assessed by lateral lumbosacral angle radiographs. RESULTS: Using the myelographical findings, small, medium, and large herniations were digested by chymopapain with more of the failures being the larger ones. There was an equal degree of degenerative change as measured by disc height loss in the young and older age groups and the degree of degenerative change did not relate to outcome. The size of the defect did not relate to the degree of disc height loss. There was a slight loss of disc height over time in both groups. There was no difference in the loss of disc height between the treatments at any of the follow-up time points. CONCLUSION: Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis. The loss of disc height over time is the same in both groups. The authors think that restoration of its availability would be beneficial to patients. LEVEL OF EVIDENCE: 1.

Prospective randomized trial of chemonucleolysis compared with surgery for soft disc herniation with 1-year, intermediate, and long-term outcome: part I: the clinical outcome.

STUDY DESIGN: A prospective consecutive series of 100 patients computer randomized into 2 groups to have treatment by either chemonucleolysis or surgery. OBJECTIVE: To compare the complications and clinical outcome between the groups at 1 year, and at 10 to 13 and 24 to 27 years. SUMMARY OF BACKGROUND DATA: Chemonucleolysis was introduced in 1964 and became widely used. Its efficacy was proven by several randomized studies when compared with a placebo and surgery. The manufacturing of Chemonucleolysis was ceased in 2001. METHODS: One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. They were followed up at 1 year with self-assessment questionnaires to establish if they were completely better, improved, the same or worse. At 10 to 13 years, 61 patients (32 chemonuceolysis and 29 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were self-assessed by questionnaire according to the Macnab criteria. RESULTS: Forty-eight patients were treated by chemonucleolysis and 52 by surgery. Ten patients treated by chemonucleolysis underwent surgery within 8 weeks. At 1 year, 10 to 13 years, and 24 to 27 years, 94%, 72%, and 63% of patients treated by chemonucleolysis had good or excellent results compared with 96%, 72%, and 67% of patients who underwent surgery, respectively. There was no difference in the clinical outcome between the treatments at any of the follow-up time points. There were 2 serious complications, 1in each treatment group. CONCLUSION: Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis, with reduced complications, and age has no bearing on the outcome. The authors think that restoration of its availability would be beneficial to patients. LEVEL OF EVIDENCE: 1.

A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters.

STUDY DESIGN: Multicenter randomized controlled trial. OBJECTIVE: To compare the efficacy and safety of balloon kyphoplasty (BKP) with nonsurgical management (NSM) during 24 months in patients with painful vertebral compression fractures (VCFs). SUMMARY OF BACKGROUND DATA: Recently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographical vertebral deformity results. METHODS: Adults with 1 to 3 VCFs were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life assessments and objective functional (timed up and go) and radiographical assessments were collected. RESULTS: Compared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at 1 month (5.35 points; 95% CI, 3.41-7.30; P < 0.0001) and when averaged across the 24 months (overall treatment effect 2.71 points; 95% CI, 1.34-4.09; P = 0.0001). The kyphoplasty group also had greater functionality by assessing timed up and go (overall treatment effect -2.49 s; 95% CI, -0.82 to -4.15; P = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.13° of correction for kyphoplasty compared with 0.82° in the control, P = 0.003). Number of baseline prevalent fractures (P = 0.0003) and treatment assignment (P = 0.004) are the most predictive variables for PCS improvement; however, in patients who underwent BKP, there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) than the quart having lowest correction of angulation (7.40 points, P = 0.0146 for difference). The most common adverse events temporally related to surgery (i.e., within 30 d) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM), and urinary tract infection (10 BKP, 3 NSM). Several other adverse events were possibly related to patient positioning in the operating room. CONCLUSION: Compared with NSM, BKP improves patient quality of life and pain averaged during 24 months and results in better improvement of index vertebral body kyphotic angulation. Perioperative complications may be reduced with more care in patient positioning. LEVEL OF EVIDENCE: 2.

Two-year results of X-stop interspinous implant for the treatment of lumbar spinal stenosis: a prospective study.

STUDY DESIGN: Prospective Observational Study. OBJECTIVE: To prospectively assess the clinical outcome of patients treated for symptomatic spinal stenosis with the X-stop device. SUMMARY OF BACKGROUND DATA: The X-stop device is used in the treatment of symptomatic lumbar spinal stenosis. The preliminary results of this study of 40 patients at 1 year were published in 2007. The 2-year results of 57 patients are reported in this paper. Zucherman et al report 60% significant improvement at 1 year and 48.4% at 2 years. METHODS: Fifty-seven consecutive patients with radiologically confirmed lumbar spinal stenosis were enrolled and treated with the X-stop device. The device was implanted at a maximum of 2 affected levels. Clinical response was evaluated with the Zurich Claudication Questionnaire (ZCQ), Oswestry Disability Index, and Short Form-36 questionnaires preoperatively and 6, 12, and 24 months postoperatively. RESULTS: Of the 57 patients enrolled, 54 completed the ZCQ questionnaire at 1 year and 46 patients at 2 years. Clinically significant improvement was attained by 65% at 1 year and 57% at 2 years and 70% were satisfied with the outcome of the surgery. Single level and double level insertions did not have significant difference in clinical outcome. CONCLUSION: This study demonstrates with the use of ZCQ scores as primary outcome measures that improved clinical outcomes are maintained at 2 years after X-stop implantation.

Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures.

Balloon kyphoplasty (BKP) is a minimally invasive surgical procedure indicated for treatment of painful vertebral compression fractures. During BKP, cannulae are placed percutaneously into the vertebral body, allowing insertion of inflatable balloons. Inflating the balloons partially restores vertebral body height, compacts the bone and creates a cavity for placement of bone cement after balloon removal. Placement of the cement reduces and stabilizes the fracture. BKP differs from vertebroplasty in that it aims to restore vertebral height and reduce kyphotic deformity. Case reports and observational studies have consistently shown that BKP significantly reduces pain, increases mobility and functional capacity and improves quality of life for up to 3 years. Clinically significant adverse events have been rarely reported. These findings were confirmed in randomized and nonrandomized prospective controlled studies. The objective of this review is to describe the surgical procedures involved in BKP and to review the evidence supporting its use.

Evaluation of perifacet injections and paraspinal muscle rehabilitation in treatment of low back pain. A randomised controlled trial.

BACKGROUND: Lumbar paraspinal muscle dysfunction and Low Back Pain are strongly correlated. The best treatment for non-specific Low Back Pain is still controversial. OBJECTIVE: To evaluate the efficacy of lumbar multifidus muscle retraining exercises and perifacet multifidus injections in the treatment of Low Back Pain. MATERIAL AND METHODS: 63 patients with non-specific LBP, with or without leg pain, and magnetic resonance images of paraspinal muscle degeneration only, were randomised to one of three treatment groups: A- Back education and standard physiotherapy for 10 weeks, B- Back education and gym ball exercise for 10 weeks or C- Perifacet injection into the lumbar multifidus muscle with methylprednisolone. The Oswestry Disability Index was used as the primary outcome measure and the SF-36, modified Zung depression index, modified somatic perception and McGill pain questionnaires were used as secondary outcome measures. RESULTS: 56 patients completed the trial. The Oswestry Disability Index improved in general from a mean of 29.9 to 25.9, but there were no statistically significant differences between the groups. Low back pain improved most in group C (P<0.02), while physical activities and social functioning were improved the most in group B (P<0.03). CONCLUSION: Perifacet injection and back education including a gym ball exercise program may be more effective than back education alone in relieving pain and improving physical capacity respectively. Back education including gym ball exercise could be used for non-specific Low Back Pain, as the ultimate goal should be to restore function.

Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE).

BACKGROUND: Clinical trial participants may be temporarily absent or withdraw from trials, leading to missing data. In intention-to-treat (ITT) analyses, several approaches are used for handling the missing information - complete case (CC) analysis, mixed-effects model (MM) analysis, last observation carried forward (LOCF) and multiple imputation (MI). This report discusses the consequences of applying the CC, LOCF and MI for the ITT analysis of published data (analysed using the MM method) from the Fracture Reduction Evaluation (FREE) trial. METHODS: The FREE trial was a randomised, non-blinded study comparing balloon kyphoplasty with non-surgical care for the treatment of patients with acute painful vertebral fractures. Patients were randomised to treatment (1:1 ratio), and stratified for gender, fracture aetiology, use of bisphosphonates and use of systemic steroids at the time of enrolment. Six outcome measures - Short-form 36 physical component summary (SF-36 PCS) scale, EuroQol 5-Dimension Questionnaire (EQ-5D), Roland-Morris Disability (RMD) score, back pain, number of days with restricted activity in last 2 weeks, and number of days in bed in last 2 weeks - were analysed using four methods for dealing with missing data: CC, LOCF, MM and MI analyses. RESULTS: There were no missing data in baseline covariates values, and only a few missing baseline values in outcome variables. The overall missing-response level increased during follow-up (1 month: 14.5%; 24 months: 28%), corresponding to a mean of 19% missing data during the entire period. Overall patterns of missing response across time were similar for each treatment group. Almost half of all randomised patients were not available for a CC analysis, a maximum of 4% were not included in the LOCF analysis, and all randomised patients were included in the MM and MI analyses. Improved estimates of treatment effect were observed with LOCF, MM and MI compared with CC; only MM provided improved estimates across all six outcomes considered. CONCLUSIONS: The FREE trial results are robust as the alternative methods used for substituting missing data produced similar results. The MM method showed the highest statistical precision suggesting it is the most appropriate method to use for analysing the FREE trial data. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov (number NCT00211211).

Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial.

Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p < .0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (~18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points.

The increase in dural sac area is maintained at 2 years after X-stop implantation for the treatment of spinal stenosis with no significant alteration in lumbar spine range of movement.

BACKGROUND CONTEXT: The X-stop interspinous process decompression (IPD) device has been used effectively in the management of symptomatic spinal stenosis. This study examines the radiological outcomes at 2 years postoperatively after X-stop implantation. PURPOSE: To measure the effect of X-stop IPD device on the dural sac and foraminal areas at 24 months postoperatively at instrumented level in symptomatic lumbar canal stenosis. We also aimed to assess its effect on change in lumbar spine movement. STUDY DESIGN: Prospective observational study. PATIENT SAMPLE: Forty-eight patients treated with X-stop had preoperative positional magnetic resonance imaging (MRI) scans, 40 of whom had 2 years postoperative positional MRI scans. Complete scans were available for 39 of these patients. OUTCOME MEASURES: Positional MRI scans were performed pre- and postoperatively. Measurements were done on these scans and are presented as the outcome measures. METHODS: All patients had a multipositional MRI scan preoperatively and at 6 and 24 months postoperatively. Foraminal area was measured in flexion and extension. Dural cross-sectional area was measured in standing erect and in sitting neutral, flexion, and extension (sitting) positions. The total range of movement (ROM) of the lumbar spine and individual segments was also measured. RESULTS: Complete scan data for 39 patients' scans were available. An increase in mean dural sac area was found in all positions. At 24 months after surgery, the mean dural sac area increased significantly in all four postures mentioned above. A small increase in mean foraminal area was noted, but this was not statistically significant. Mean anterior disc height reduced from 5.9 to 4.1 mm (p=.006) at 24 months at the instrumented level in single-level cases, from 7.7 to 6.1 mm (p=.032) in double-level cases caudally, and from 8.54 to 7.91 (p=.106) mm cranially. We hypothesize that the reduction in anterior disc heights could be a result of the natural progression of spinal stenosis with aging. There was no significant change in posterior disc heights at instrumented level or adjacent levels. The mean lumbar spine motion was 21.7 degrees preoperatively and 23 degrees at 24 months (p=.584) in single-level cases. This was 32.1 degrees to 31.1 degrees (p=.637) in double-level cases. There was no significant change in the individual segmental range of motion at instrumented and adjacent levels. CONCLUSION: X-stop interspinous device remains effective in decompressing the stenosed spinal segment by increasing the anatomic dural cross-sectional area and foraminal area of spinal canal. It does not significantly alter the ROM of lumbar spine at instrumented and adjacent levels at 24 months postoperatively.

Qualitative grading of severity of lumbar spinal stenosis based on the morphology of the dural sac on magnetic resonance images.

STUDY DESIGN: Retrospective radiologic study on a prospective patient cohort. OBJECTIVE: To devise a qualitative grading of lumbar spinal stenosis (LSS), study its reliability and clinical relevance. SUMMARY OF BACKGROUND DATA: Radiologic stenosis is assessed commonly by measuring dural sac cross-sectional area (DSCA). Great variation is observed though in surfaces recorded between symptomatic and asymptomatic individuals. METHODS: We describe a 7-grade classification based on the morphology of the dural sac as observed on T2 axial magnetic resonance images based on the rootlet/cerebrospinal fluid ratio. Grades A and B show cerebrospinal fluid presence while grades C and D show none at all. The grading was applied to magnetic resonance images of 95 subjects divided in 3 groups as follows: 37 symptomatic LSS surgically treated patients; 31 symptomatic LSS conservatively treated patients (average follow-up, 2.5 and 3.1 years); and 27 low back pain (LBP) sufferers. DSCA was also digitally measured. We studied intra- and interobserver reliability, distribution of grades, relation between morphologic grading and DSCA, as well relation between grades, DSCA, and Oswestry Disability Index. RESULTS: Average intra- and interobserver agreement was substantial and moderate, respectively (k = 0.65 and 0.44), whereas they were substantial for physicians working in the study originating unit. Surgical patients had the smallest DSCA. A larger proportion of C and D grades was observed in the surgical group. Surface measurements resulted in overdiagnosis of stenosis in 35 patients and under diagnosis in 12. No relation could be found between stenosis grade or DSCA and baseline Oswestry Disability Index or surgical result. C and D grade patients were more likely to fail conservative treatment, whereas grades A and B were less likely to warrant surgery. CONCLUSION: The grading defines stenosis in different subjects than surface measurements alone. Since it mainly considers impingement of neural tissue it might be a more appropriate clinical and research tool as well as carrying a prognostic value.

Incidence of thromboembolic complications in lumbar spinal surgery in 1,111 patients.

Deep venous thrombosis (DVT) and pulmonary embolism (PE) cause significant morbidity and mortality in orthopaedic surgical practice, although the incidence following surgery to the lumbosacral spine is less than following lower limb surgery. Our objective was to compare our rate of thromboembolic complications with those published elsewhere and investigate whether the adoption of additional pharmacological measures reduced the incidence of clinically evident DVT and PE. This retrospective study was undertaken to investigate the incidence of DVT/PE during the 10 years from 1 January 1985 to 31 December 1994, and then to assess the effectiveness of an anticoagulant policy introduced during 1995 using low dose aspirin or LMH in high risk cases. All records for spinal operations were reviewed for thrombo-embolic complications by reference to the Scottish Morbidity Record form SMR1. To ensure that all patients were compliant with the policy, data for the whole of 1995 was omitted and the period 1 January 1996 to 31 December 2003 was taken to assess its effectiveness. Surgery was done with the patient in the kneeling, seated prone position which leaves the abdomen free and avoids venous kinking in the legs. Records of a total of 1,111 lumbar spine operations were performed from 1 January 1985 to 31 December 2004 were reviewed. The overall incidence of thrombo-embolic complications was 0.29%. A total of 697 operations were performed from 1 January 1985 to 31 December 1994 with two cases of DVT and no cases of PE giving thromboembolic complication rate of 0.29%. During the period 1 January 1996 to 31 December 2003, 414 operations resulted in one case of DVT and no cases of PE, a rate of 0.24%. The incidence of symptomatic thrombo-embolic complications in lumbar spinal surgery is low in the kneeling, seated prone operating position, whether or not anticoagulation is used.

Early catastrophic acetabular failure in Furlong total hip replacements.

The use of uncemented hip arthroplasty prostheses with ceramic articulations are popular, especially in the young, because of a perceived reduction in wear. We highlight a complication of ceramic on polyethylene articulating couples not previously described in the Furlong replacement. Despite widespread metalosis and particulate debris, osteolysis was not initially seen. The contamination compromised subsequent revision.

Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial.

BACKGROUND: Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. METHODS: Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. FINDINGS: 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7.2 points (95% CI 5.7-8.8), from 26.0 at baseline to 33.4 at 1 month, in the kyphoplasty group, and by 2.0 points (0.4-3.6), from 25.5 to 27.4, in the non-surgical group (difference between groups 5.2 points, 2.9-7.4; p<0.0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. INTERPRETATION: Our findings suggest that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option.

Disc changes in the bridged and adjacent segments after Dynesys dynamic stabilization system after two years.

STUDY DESIGN: Prospective case series. OBJECTIVE: To study the radiologic changes in the intervertebral disc after Dynesys dynamic stabilization. SUMMARY OF BACKGROUND DATA: Adjacent segment disc degeneration is one of the potential complications of fusion surgery. It has been proposed that nonfusion motion preservation surgery may prevent accelerated adjacent segment degeneration because of the protective effect of persisting segmental motion. METHODS: Thirty-two patients who underwent Dynesys procedure between November 2002 and June 2004 and have completed 2-year follow-up MRI scans were included in this study. Preoperative and 2 year postoperative lumbar MRI scans were evaluated by 2 independent observers. T2-weighted mid-sagittal images were used and disc degeneration classified according to the Woodend classification of disc degeneration. Anterior and posterior intervertebral disc heights were also measured. RESULTS: Of the 32 patients, 20 patients underwent Dynesys procedure alone and 12 underwent additional fusion at 1 or more levels. A total of 70 levels were operated on, of which 13 levels were fused.There was a statistically significant increase in the mean Woodend score at the operated levels in the Dynesys alone group, a change from 1.95 before surgery to 2.52 after surgery (P < 0.001). The mean Woodend scores changed from 1.27 preoperative to 1.55 postoperative (P = 0.066) at the proximal adjacent levels, and from 1.37 to 1.62 at the distal levels (P = 0.157). There was good interobserver agreement (weighted kappa score of 0.819). The anterior intervertebral disc height reduced by 2 mm from 9.25 to 7.17 (P < 0.001). The posterior disc height increased by 0.14 mm but this change was not significant. CONCLUSION: Disc degeneration at the bridged and adjacent segment seems to continue despite Dynesys dynamic stabilization. This continuing degeneration could be due to natural disease progression.

Painful disc lesion: can modern biplanar magnetic resonance imaging replace discography?

STUDY DESIGN: A new magnetic resonance imaging (MRI) classification of disc degeneration was correlated with discography. It was also studied for intraobserver and interobserver variability in interpreting disc abnormality and for the capability in predicting symptomatic disc. OBJECTIVE: To correlate the results of discography with a new MRI classification for disc degeneration and the presence of the vertebral endplate changes and the high intensity zone (HIZ). SUMMARY OF BACKGROUND DATA: MRI and discography have been compared in numerous studies as methods for detecting disc degeneration. The results were conflicting and the role of MRI in assessing discogenic pain remains ambiguous. METHODS: One hundred thirty-one discs in 55 patients were studied with pain provocation discography and MRI. A new MRI classification was correlated to discography and assessed together with the presence of end plate changes and HIZ, by the sensitivity and specificity in predicting a painful disc. RESULTS: MRI classification had a good intra and interobserver agreement and a significant correlation with discographic findings. The sensitivity and specificity of MRI in predicting painful disc was 94% and 77%. The sensitivities and specificity of HIZs was 27% and 87% and for end plate changes was 32% and 98%, respectively. CONCLUSIONS: Although MRI is an excellent investigation for assessing disc morphology it should be interpreted along with discography findings before planning fusion surgery. The proposed MRI classification is a useful aid in predicting painful degenerative disc. The utility of HIZs and end plate changes is limited due to low sensitivity.