Assessment of long term results of Chemonucleolysis vs. surgery for soft disc herniation From 1982 to 1985, 100 patients with symptomatic disc herniation were randomly allocated to receive either Chemonucleolysis(48) or surgery(52) after a three months trial of conservative treatment. Ten of the chemonucleolysis had surgery. At 10–13 year follow up, Sixty one of the original 100 patients responded, (32 chemonucleolysis; 29 surgery). At 25–27 year Forty four patients responded (24 chemonucleolysis; 20 surgery). Clinical outcome at one year was according to a self-assessment questionnaire: Completely, better improved, the same, or worse, and at the later follow up periods, according to the Macnab criteria. The results of two groups of patients were compared using Chi square and T test for independent samples. The disc height of the affected disc was measured from the lateral lumbar spine radiograph taken pre-operatively, and at the later two time points, and compared to a normal adjacent disc expressed as a percentage.Purpose of the Study
Material and Methods
To compare the efficacy and safety of balloon kyphoplasty (BKP) to non-surgical management (NSM) over 24 months in patients with acute painful fractures by clinical outcomes and vertebral body kyphosis correction and surgical parameters. Three hundred Adult patients with one to three VCF's were randomised within 3 months of the acute fracture; 149 to Balloon Kyphoplasty and 151 to Non-surgical management. Subjective QOL assessments and objective functional (Timed up and go [TUG]) and vertebral body kyphotic angulation (KA), were assessed over 24 months; we also report surgical parameters and adverse events temporally related to surgery (within 30-days).Purpose
Material and Methods
Lumbar paraspinal muscle dysfunction and low back pain are strongly correlated. Muscle atrophy is common in LBP and is recognised by MRI scan. Corticosteroid injections and physical rehabilitation programs are advocated for treatment of LBP. The purpose is to evaluate efficacy of specific lumbar multifidus muscle retraining exercises and perifacet multifidus injections in treatment of Low Back Pain (LBP) and referred leg pain. 63 patients with non-specific LBP, with or without leg pain, were randomised to three treatment groups. MR images of paraspinal muscle and the atrophy classified. A-Control group, standard physiotherapy for 10 weeks. B-Multifidus rehabilitation program for 10 weeks. C-Perifacet injection (multifidus injection) with methylprednisolone. ODI was primary outcome measure and the SF-36, modified Zung Depression Index and others were secondary outcome measures.Purpose
Method
To identify any difference in clinical outcome between Intra-Capsular facet (IF) and Peri-facet (PF) injections in patients with low back pain (LBP). IF and PF joint steroid injections have been used for treatment of LBP with varied reports of pain relief for many years. Patients randomised into IF and PF groups. Bilateral L4/5 and L5/S1 levels injected. 40mg of Depo-Medrone with Lignocaine (total 1ml) in IF group. 80mg of Depo-Medrone with 1ml of 0.5% Chirocaine (total 3ml) in PF group. Pain visual analogue score (VAS) and analgesic chart – completed till six months.Objective
Methods
Balloon kyphoplasty (BKP) is a minimally invasive treatment for vertebral fractures (VCF) aiming to correct deformity using balloon tamps and bone cement to stabilize the body. Patients with 1 - 3 non-traumatic acute VCF were enrolled within three months of diagnosis and randomly assigned to receive either BKP (N=149) or nonsurgical care (N=151). Follow-up was 2 years. The mean SF-36 physical component summary (PCS) score improved 5.1 points (95%CI, 2.8-7.4; p<0.0001) more in the kyphoplasty than the nonsurgical group at one month, the primary endpoint of the study. Kyphoplasty improved the PCS score by an average of 3.0 points (95%CI, 1.6-5.4; p=0.002) during the two-year follow-up. There was a significant interaction between treatment and follow-up time (p=0.003), indicating that the treatment effect over the year is not uniform across follow-up; a result from early improvement that persists in the kyphoplasty group whereas the nonsurgical group shows more incremental improvement over time. Overall, patients assigned to kyphoplasty also had statistically significant improvements over the two years compared to the control group in global quality of life (EQ-5D), pain relief (VAS), back disability (RMDQ) and days of limited activity (within a two-week period). There was no statistical significant difference between groups in the number of patients with adverse events or new VCF's over 24 months. Compared to the control, BKP improved quality of life and reduced back pain and disability and did not increase adverse events including the risk of new vertebral fractures over 2 years.
Assessment of long term results of Chemonucleolysis vs. surgical enucleation in soft disc herniation From 1982 to 1985, 100 patients with symptomatic disc herniation were randomly allocated to receive either Chemonucleolysis or disc enucleation after all these patients had a trial of conservative treatment for three months. The outcome of result was measured using MacNab Criteria with the help of Questionnaire Assessing the patients in clinic 44 patients out of original 100 patients were followed up in the clinic 25 years later. 24 were from chemonucleolysis group and 20 from the surgical group. According to MacNab criteria 62.5% had excellent or good results and 25% poor results in chemonucleolysis group and in surgery group 70% had excellent or good results and 10% poor results. Patients with poor result in Chemonucleolysis group consisted of: a) 1 had poor result post TKR, b) 4 were offered surgical enucleation subsequent to failed Chemonucleolysis though they did not seem to benefit from surgery and 1 out of these 4 also had fibromyalgia. c) 1 had poor result after sustaining fracture neck of femur. Poor results in surgical group were due to persistent back pain. The results at 25 year follow-up have shown no statistically significant difference between the patients treated by either chemonucleolysis or surgery. The added benefit of using the chymopapain injection is that it is of lower cost. Chemonucleolysis should have a wider role in treatment of intervertebral disc herniation.
Vertebral body compression fractures (VCFs) impair quality of life (QOL) and increase patient morbidity and mortality. The international, multicentre, randomised, controlled Fracture Reduction Evaluation (FREE) trial was initiated to compare effectiveness and safety of Balloon kyphoplasty (BKP) to non-surgical management (NSM) for the treatment of acute painful VCFs. We describe the primary endpoint of the ongoing 2-year study. Patients with 1-3 non-traumatic VCFs (< 3 months old) were randomised to either BKP or NSM. The primary endpoint was the change in QOL as measured by the SF-36 Health Survey Physical Component Summary (PCS) at one month, and device/procedure-related safety. Secondary endpoints included SF-36 subscales, the EQ-5D, self-reported back pain and function using the Roland Morris Disability Questionnaire (RMDQ). All patients were given osteoporosis medical therapy.Background
Methods
Thirty-six patients had MRI at 2 years. Using paired t test we noted statistically significant increase in mean dural sac area in all four positions mentioned above. There was clinical improvement in 26 and some or no improvement in 10 patients. Number with increase in canal cross sectional area was 28 and that with reduced area was 8. Clinical and canal area improvement was seen in 20 (56%) patients and clinical improvement with reduced canal area was seen in 5 (14%). Some or no clinical improvement with canal area improvement occurred in 8 (22%) patients and no significant clinical or canal area improvement in 3 (8%).
Majority of patients (56%) showed clinical and cross sectional area improvement at 2 years. One patient with no clinical improvement had subsequent decompression surgery (this patient had dural cross sectional area improvement). 64% patients had similar clinical and dural cross sectional area changes but there is not a clear-cut correlation between clinical outcome and change in canal cross-sectional area.
Surgery was done with the patient in the kneeling, seated prone position which leaves the abdomen free and avoids venous kinking in the legs.
Clinical outcome was assessed by Zurich claudication questionnaire (ZCQ), visual analogue score (VAS), Oswestery disability index (ODI) and SF36 questionnaires preoperatively and at 2 years. ZCQ has three components- symptom severity, physical function and patient satisfaction. ZCQ is considered the most precise, reliable and condition specific questionnaire for lumbar canal stenosis. Out of 57 patients, 2 died due to unrelated causes, 3 withdrew from study and 3 had the device removed within 2 years. Forty-five, 44, 42 and 48 completed ZCQ, ODI, SF-36 and VAS respectively at 24 months.
The mean ODI improved by 6.5 in single level and 10.8 in double level cases. The SF-36 showed improvement in physical function, role physical, bodily pain and vitality social domain. Average hospital stay for the procedure was 1.6 days. One patient stayed for 10 days for investigation unrelated to the procedure. There were no major complications.
The patients were divided into two groups, A and B. The first, Group A, in which only Dynesys was used and the second, Group B, in which Dynesys was used adjacent to one or more fused segments.
The ROM of the end plate angle at the instrumented segments in Group A reduced from 5.72o to 1.44o{difference 4.28o(p=0.005)} and in Group B reduced from 6.00o to 2.17o,{difference 3.83o(p=0.001)}. The ROM of the end plate angle at the level above instrumentation in Group A reduced from 8.2o to 5.1o {reduction 3.1o(p=0.085)}, while in group-B increased from 7.3o to 7.5o, a difference of 0.2o (p=0.877). The mean anterior disc height in Group A reduced by 2.1mm (p<
0.001) from 9.59mm to 7.44mm. The posterior disc height also reduced from 6.56mm to 6.26mm, a difference of 0.3mm, (p=0.434). In Group B, the anterior disc height reduced by 1.98mm (pre-op=9.04mm, post-op= 7.06mm, p=0.001) and the posterior height by 0.35mm (pre-op 6.14mm to post op 5.79mm, p=0.443)
At 6 months, there was a significant increase in the spinal canal and foraminal dimension. However at 2 years there was a reduction in these dimensions such that there was no significant difference from the preop-erative measurements.
Mean IL-6 levels were higher in groups of patients with more distress measured by the DRAM and HADS depression component but were lower in patients with more anxiety. IL-6 receptor levels were higher in patients with raised DRAM and HADS anxiety scores. No significant correlation between questionnaire responses and cytokine levels was found. A correlation exists between IL-6 and CRP levels even at normal levels of CRP.
The patients were divided into two groups, A and B. The first, Group A, in which only Dynesys was used and the second, Group B, in which Dynesys was used adjacent to one or more fused segments.
The ROM of the end plate angle at the instrumented segments in Group A reduced from 5.72o to 1.44o{difference 4.28o(p=0.005)} and in Group B reduced from 6.00o to 2.17o,{difference 3.83o(p=0.001)}. The ROM of the end plate angle at the level above instrumentation in Group A reduced from 8.2o to 5.1o {reduction 3.1o(p=0.085)}, while in group-B increased from 7.3o to 7.5o, a difference of 0.2o (p=0.877). The mean anterior disc height in Group A reduced by 2.1mm (p<
0.001) from 9.59mm to 7.44mm. The posterior disc height also reduced from 6.56mm to 6.26mm, a difference of 0.3mm, (p=0.434). In Group B, the anterior disc height reduced by 1.98mm (pre-op=9.04mm, post-op= 7.06mm, p=0.001) and the posterior height by 0.35mm (pre-op 6.14mm to post op 5.79mm, p=0.443)
The ZCQ, ODI, SF-36 and VAS were completed preoperatively and at 12 months by 54, 50, 52, 52 respectively. Thirty-nine patients completed all questionnaires at all time points and the maximal clinical efficacy was evident 3 months post-operatively. Clinical significant improvement was maintained at the 6- and 12 month post-operative follow-ups despite a minimal loss of clinical efficacy in absolute mean values. Overall, clinically significant response was achieved in 65%. Seventy-one per cent of double level patients and 61% of single level patients as determined by the ZCQ, had a clinically significant response. Corresponding changes were seen in VAS and ODI and SF-36. Ten patients (18%) required caudal epidural for recurrence of symptoms and 1 patient required perifacet injections for back pain.
The patients were assessed pre-operatively and post-operatively at 6 weeks, 3, and 6 months using Visual Analogue pain scale (VAS), Oswestry Disability index (ODI), SF-36 Health Survey (SF-36) and positional MRI scan in sitting (flexion, extension and neutral), erect and supine positions. To date, seven patients have a six-month follow up.
Thirty patients with were treated with Dynesys system. All had discography and positional MRI preoperatively and nine months post-operatively. The patients were divided in to two groups. The first in which only Dynesys was used and the second in which Dynesys was used with fusion.
The ROM of the end plate angle at the instrumented segments in group-A reduced from 5.24o to 2.18o{difference 3.06o(p<
0.005)} and in group-B reduced from 6.69o to 2.46o,{difference 4.23o(p=0.008)}. The ROM of the end plate angle at adjacent level in group-A changed from 8.26o to 7.0o {reduction 1.26o(p=0.388)},while in group-B increased from 6.91o to 8.64o, {difference 1.73o(p=0.149)} The mean anterior disc height in-group A reduced by 1.43mm (p<
0.005) from 9.75mm to 8.32mm, and the posterior one was increased from 6.27mm to 6.77mm {difference of 0.5mm,(p=0.008)}. In group-B the anterior disc height reduced by 1.11mm (pre-op=10.44mm,post-op= 9.33mm,p=0.049) and the posterior one by 0.16mm (pre-op 6.98mm to post-op 6.82mm,p=0.714).
Images were taken in sitting flexed, extended, neutral, and standing. The total range of motion of the lumbar spine and of the individual segments were measured, along with changes in disc height, areas of the exit foramina, and dural sac. The mean area of the dural sac at the operated levels increased from 62.46mm2 to 77.69mm2 (p=0.004) in the standing posture and from 70.85mm2 to 94.62mm2 (p=0.019) in extension postoperatively. The area of the exit foramina in extension increased from 83.57mm2 to 107.88mm2 (p=0.002) on the left side and from 83.77mm2 to 108.69mm2 (p=0.012) on the right. The overall changes in the range of movement of the individual segments or of the lumbar spine were statistically insignificant.
The patients were divided into two groups. The Group-A with 14 patients in which only Dynesys was used and Group-B with 11 patients in which Dynesys was combined with fused levels. The operated levels were 51, 13 of which were fused. The results showed that the mean range of movement of the lumbosacral angle reduced by 10.28° (Preop=39.21°, Postop=28.93°) (p=0.016) in group-A. In group-B it reduced by 13.73° (Preop=36.18°, Postop=22.45°) (p=0.02). The range of movement of the end plate angle at the instrumented segments in group-A reduced by 2.96° (Preop=5.56°, Postop=2.60°) (p=0.016) while in group-Bit reduced by 4.23° (Preop=6.69°, Postop=2.46°)(p=0.008). The mean range of movement of the end plate angle at adjacent level in group-A reduced by 1.58° (Preop=8.7°, Postop=7.21°)(p=0.427) while in group-B it increased by 1.73° (Preop=6.91°, Postop=8.64°) (p=0.149) The mean anterior disc height in group-A reduced by 1.18mm (Preop=10.05mm, Postop=8.87mm) (p<
0.005), and the posterior one was increased by 0.6mm (Preop=6.51mm, Postop=8.87mm) (p=0.013). In group-B, the anterior disc height was reduced by 1.11mm (Preop= 10.44mm, Postop=9.33mm) (p=0.049) and the posterior one by 0.16mm (Preop=6.98mm Postop=6.82mm) (p=0.714)
This study measures the changes in the lumbar spine in different postures, pre- and after insertion of the device.
All had a positional MRI preoperatively and nine months post-operatively in flexion-extension-lateral bending. The patients were divided in to two groups: Group(A) with 8 patients in which Dynesys was used with fusion (disc-height<
40 %) Group(B) with 12 patients was the Dynesys-only group (disc-height=40–90%).
The changes in the anterior disc height was (mean= −1.18)(p<
0.05) and to the posterior (mean=0.37)(p=0.134). In bending were (mean=−0.87°)(p=0.18) for left and (mean=−0.24°)(p=0.75) for the right
21 patients (11 males; 10 females) were included in the study. Age ranged from 57 – 88 years. All had symptomatic lumbar spinal stenosis- single level- 13 (L2/3-1; L3/4-3; L4/5-9); double level 8(L3/4, L4/5 – 7; L4/5, L5/ S1 – 1).
This study measures the changes in the lumbar spine in different postures, pre- and after insertion of the device. Methods In our study 25 patients with dominant low back pain, with or without leg pain, were treated with Dynesys system, 14 females and 11 males with mean age 43.5 yrs. Discography was done to evaluate the symptomatic painful level. All patients had a positional magnetic resonance imaging (pMRI) scans preoperatively and nine months post-operatively in standing; sitting flexion and extension, and left and right bending postures. The patients were initially divided into two groups. The first (Group A) with 14 patients in which only Dynesys was used (disc height 40–90%) and the second (group B) with 11 patients in which Dynesys was used with fusion (disc height <
40 %).
The range of movement of the end plate angle at the instrumented segments in group A reduced from 5.6° preoperatively to 2.6° with a difference of 3.0° (p=0.016) while in group B it reduced from 6.7° to 2.5° postoperatively with a difference of 4.2°(p=0.008). The range of movement of the end plate angle at adjacent level in group A changed from 8.8° preop. to 7.2° with a reduction of 1.6° (p=0.427) while in group B it increased from 6.9° to 8.6°, difference of 1.7° (p=0.149) The mean anterior disc height in group A reduced by 1.2mm (p<
0.005) from 10.1mm to 8.9mm postoperatively, and the posterior one was increased from 6.5mm to 8.9mm with a difference of 0.6mm (p= 0.013). In group B the anterior disc height was reduced by 1.1mm (pre-op 10.4mm to post-op 9.3mm; p=0.049) and the posterior one by 0.16mm (pre-op 6.98mm to post-op 6.82mm; p=0.714)
Here we discuss the evaluation of two spinal devices: Dynesys, a spinal stabilisation system for back pain, and X STOP, an interspinous process distraction device for spinal stenosis.
For Dynesys, 30 patients with lower back pain were recruited. The first 20 patients have completed their 9 month scan, and the results show that the device reduces the range of movement at the operated segments, with a small increase in movement at adjacent segments and an overall reduction in the range of movement of the lumbar spine. For X STOP, the first 10 of 45 have reached their second scan at 6 months post surgery. The scans demonstrate a net increase in the cross-section of the spinal canal of 21% when flexed to 35% whilst standing, and an increase in the surface area of the exit foramen of 23% flexed and 51% standing at operated levels.
To assess the radiological outcome of instrumented posterolateral lumbar fusion in a prospective randomised study comparing the use of allograft (fresh frozen human femoral head) to autologous bone (from the posterior iliac crest), using a validated method. One hundred and twenty four radiographs of patients who had undergone instrumented posterolateral spinal fusion were assessed for fusion or non-fusion by three independent observers using the same criteria, and a second time by one of the observers. The Kappa scores for the inter-observer and intra-observer agreement were calculated. Thirty-three of these patients had fusion status verified by the gold randomised to one of two groups, to receive either allograft bone or autologous bone. The same surgeon using the same surgical technique performed or supervised all cases. The radiological results of the two groups were assessed as well as the quality of fusion. Both the inter-observer and intra-observer kappa scores (k) were 100%. The sensitivity of the method was 87.9% and the specificity was 100%. Thirty-seven patients received allograft and 32 patients received autograft. There was no significant difference in the fusion rate, or the quality and quantity of the graft between the groups. There is no difference in the fusion rates comparing the use of autograft and allograft for posterolateral instrumented lumbar fusion.
This prospective study was carried out to correlate findings of magnetic resonance imaging (MRI) and discography. Fifty-five consecutive patients with degenerative disc disease not responding to non-operative treatment were included in the study. There were 19 men and 36 women and the mean age was 45 years. Discography was carried out on 131 disc levels. The discograms were classified using modified Adams’s classification and pain recorded into three grades. MRI scans were graded using a new classification system based on parasagittal and axial images by two independent observers blinded to discography findings. There was good intraobserver (kappa 0. 74) and interobserver (kappa 0. 70) agreement for the classification system. There was a significant correlation in the morphology of discs as determined by discograms and MRI classification (p<
0. 001). Each disc was graded on MRI scan as painful or painless on basis of defined criteria. Concordant discography pain was considered as the gold standard. The sensitivity and specificity of MRI in predicting symptomatic disc using defined criteria was 94% and 77%. The sensitivities and specificity of high intensity zones was 27% and 87% and for end plate changes was 32% and 98% respectively. In 14 patients (25%) the findings of MRI and discography did not correlate. In conclusion though 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 high intensity zones and end plate changes is limited due to low sensitivity.
The role of MRI or CT in the management of patients with LBP, for whom there is no clear clinical indication for the use of sophisticated imaging, is uncertain. The aim of The Scottish Back Trial was to determine whether early use of MRI or CT influences clinical management and outcome of patients with LBP and whether it is cost-effective. Elective patients were new referrals to orthopaedic or neurosurgeons with symptomatic lumbar spine disorders (without ‘red flags’). After obtaining informed consent, patients were randomised to ‘early imaging’ (imaging as soon as practicable) or ‘delayed, selective imaging’ (imaging only if an imperative clinical indication developed). Principal outcomes measures were the SF-36, questionnaire, the Aberdeen LBP Scale and the EQ-5D. Patients completed questionnaires at trial entry and after 8 and 24 months. From 15 hospitals, 2657 patients were assessed and 783 were recruited and randomised. Eight months and twenty-four months after trial entry, comparison of data abstracted from case notes indicated that, apart from the use of imaging, both groups had received similar clinical management. At follow-up, an improvement in health status, as measured by the SF-36 and Aberdeen LBP Scale, was reported by both groups. At 24 months, there was a statistically significant but small difference in favour of the ‘early imaging’ group (p=0. 002) as measured by the Aberdeen LBP Scale but no difference in the SF-36 except a marginal improvement in the bodily pain subscale. The use of MRI or CT imaging for this group of LBP patients did not significantly affect their management. The clinical significance of the marginal improvement in health status in the ‘early imaging’ group is uncertain. The results of the cost-effectiveness analysis may clarify whether a policy of ‘early imaging’ would be a cost effective use of resources.
We carried out a randomised, prospective, multicentre clinical trial of the treatment of Colles’ fractures. A total of 339 patients was placed into two groups, those with minimally displaced fractures not requiring manipulation (151 patients) and those with displaced fractures which needed manipulation (188 patients). Treatment was by either a conventional Colles’ plaster cast (a control group) or with a prefabricated functional brace (the Aberdeen Colles’ fracture brace). Similar results were obtained in both groups with regard to the reduction and to pain scores but the brace provided better grip strength in the early stages of treatment. This was statistically significant after five weeks for both manipulated and non-manipulated fractures. At the tenth day the results were statistically significant only in manipulated fractures. There was no significant difference in the functional outcome between the two treatment groups. However, younger patients and those with less initial displacement had better functional results.
We have assessed the current range of synthetic splinting bandages, using physical and mechanical tests and the subjective opinions of patients, volunteers and orthopaedic staff. Modern bandages have some better properties than standard plaster bandage but do not conform as well, are more expensive, and potentially more hazardous.
A series of 29 patients with fractures of the tibial plateau were treated by means of a cast-brace. There were seven wedge fractures of the lateral tibial condyle, two dicondylar fractures and 20 compression fractures involving the lateral tibial plateau. The seven patients with wedge fractures were treated by skin or skeletal traction, followed as soon as possible by flexion exercises for the knee. Cast-braces were applied to all fractures as soon as possible after injury, and the patients allowed to bear weight freely. Early restoration of function of the injured limb was thereby achieved. The results of our study over a period of two and a half years indicate that cast-bracing is a very satisfactory method of treating fractures of the tibial plateau. All the fractures united, the movements and control of the knee were excellent, and valgus or varus deformity was unchanged before application and after removal of the brace.
The off-loading characteristics of the cast-braces of 30 patients with fractures of the shaft of the femur have been investigated, during axial loading, using strain-gauge transducers. These were applied at the level of the fracture, where the cast was circumferentially split, and to the hinges of the brace at the knee. They measured the load transferred between the two portions of the thigh cast, and between the thigh cast as a whole and the below-knee cast; by subtraction from the total load on the limb, the skeletal force at the fracture level and at the knee could be calculated. In all patients there was an increase in the fracture load as union progressed which was thought to be due to physiological feedback mechanism from the fracture site. The load carried by the two portions of the thigh cast and by the thigh cast as a whole was proportionately high at first and stabilised at an average of 35 per cent of body weight.
Ninety-eight fractures of the shaft of the femur were seen in one unit over the two years 1974 and 1975, and the results have been assessed in sixty-nine. Of these, thirty-eight were treated by skeletal traction in a Thomas's splint followed by skin traction, and thirty-one by skeletal traction followed by a cast-brace. The technique of application is described in some detail. The average time for application of the cast-brace was six weeks after the injury, the time in hospital eight weeks and the time till removal fifteen weeks. The patients selected for a cast-brace were in hospital for just over half the time of the others and their fractures on average united more quickly, though with some trouble from angulation of fractures of the uppermost third of the shaft. It is concluded that when used with all the judgment and skill it demands, the cast-brace method is a great advance in conservative treatment.