This study evaluates the long-term survival of spinal implants after surgical site infection (SSI) and the risk factors associated with treatment failure.

A Kaplan-Meier survival analysis was carried out on 43 patients who had undergone a posterior spinal fusion with instrumentation between January 2006 and December 2008, and who consecutively developed an acute deep surgical site infection. All were appropriately treated by surgical debridement with a tailored antibiotic program based on culture results for a minimum of eight weeks.

A ‘terminal event’ or failure of treatment was defined as implant removal or death related to the SSI. The mean follow-up was 26 months (1.03 to 50.9). A total of ten patients (23.3%) had a terminal event. The rate of survival after the first debridement was 90.7% (95% confidence interval (CI) 82.95 to 98.24) at six months, 85.4% (95% CI 74.64 to 96.18) at one year, and 73.2% (95% CI 58.70 to 87.78) at two, three and four years. Four of nine patients required re-instrumentation after implant removal, and two of the four had a recurrent infection at the surgical site. There was one recurrence after implant removal without re-instrumentation.

Multivariate analysis revealed a significant risk of treatment failure in patients who developed sepsis (hazard ratio (HR) 12.5 (95% confidence interval (CI) 2.6 to 59.9); p < 0.001) or who had > three fused segments (HR 4.5 (95% CI 1.25 to 24.05); p = 0.03). Implant survival is seriously compromised even after properly treated surgical site infection, but progressively decreases over the first 24 months.

Cite this article: Bone Joint J 2013;95-B:1121–6.

We report the incidence of and risk factors for complications after scoliosis surgery in patients with Duchenne muscular dystrophy (DMD) and compare them with those of other neuromuscular conditions. We identified 110 (64 males, 46 females) consecutive patients with a neuromuscular disorder who underwent correction of the scoliosis at a mean age of 14 years (7 to 19) and had a minimum two-year follow-up. We recorded demographic and peri-operative data, including complications and re-operations. There were 60 patients with cerebral palsy (54.5%) and 26 with DMD (23.6%). The overall complication rate was 22% (24 patients), the most common of which were deep wound infection (9, 8.1%), gastrointestinal complications (5, 4.5%) and hepatotoxicity (4, 3.6%). The complication rate was higher in patients with DMD (10/26, 38.5%) than in those with other neuromuscular conditions (14/84, 16.7% (p = 0.019). All hepatotoxicity occurred in patients with DMD (p = 0.003), who also had an increased rate of deep wound infection (19% vs 5%) (p = 0.033). In the DMD group, no peri-operative factors were significantly associated with the rate of overall complications or deep wound infection. Increased intra-operative blood loss was associated with hepatotoxicity (p = 0.036). In our series, correction of a neuromuscular scoliosis had an acceptable rate of complications: patients with DMD had an increased overall rate compared with those with other neuromuscular conditions. These included deep wound infection and hepatotoxicity. Hepatotoxicity was unique to DMD patients, and we recommend peri-operative vigilance after correction of a scoliosis in this group. Cite this article: Bone Joint J 2014; 96-B:943–9

Aims

Postoperative complication rates remain relatively high after adult spinal deformity (ASD) surgery. The extent to which modifiable patient-related factors influence complication rates in patients with ASD has not been effectively evaluated. The aim of this retrospective cohort study was to evaluate the association between modifiable patient-related factors and complications after corrective surgery for ASD.

Aims

Lumbar disc prolapse is a frequent indication for surgery. The few available long-term follow-up studies focus mainly on repeated surgery for recurrent disease. The aim of this study was to analyze all reasons for additional surgery for patients operated on for a primary lumbar disc prolapse.

Aims

To identify the incidence and risk factors for five-year same-site recurrent disc herniation (sRDH) after primary single-level lumbar discectomy. Secondary outcome was the incidence and risk factors for five-year sRDH reoperation.

Aims

The aim of this study was to compare the clinical and radiological outcomes of patients with early-onset scoliosis (EOS), who had undergone spinal fusion after distraction-based spinal growth modulation using either traditional growing rods (TGRs) or magnetically controlled growing rods (MCGRs).

Aims

To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set.

Aims

To describe the clinical, radiological, and functional outcomes in patients with isolated congenital thoracolumbar kyphosis who were treated with three-column osteotomy by posterior-only approach.

Aims

The aim of this study was to investigate the efficacy of coccygectomy in patients with persistent coccydynia and coccygeal instability.

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To report the surgical outcome of patients with severe Scheuermann’s kyphosis treated using a consistent technique and perioperative management.

Aims

Magnetically controlled growing rods (MCGR) have been gaining popularity in the management of early-onset scoliosis (EOS) over the past decade. We present our experience with the first 44 MCGR consecutive cases treated at our institution.

Aims. We present the results of correcting a double or triple curve adolescent idiopathic scoliosis using a convex segmental pedicle screw technique. Patients and Methods. We reviewed 191 patients with a mean age at surgery of 15 years (11 to 23.3). Pedicle screws were placed at the convexity of each curve. Concave screws were inserted at one or two cephalad levels and two caudal levels. The mean operating time was 183 minutes (132 to 276) and the mean blood loss 0.22% of the total blood volume (0.08% to 0.4%). Multimodal monitoring remained stable throughout the operation. The mean hospital stay was 6.8 days (5 to 15). Results. The mean post-operative follow-up was 5.8 years (2.5 to 9.5). There were no neurological complications, deep wound infection, obvious nonunion or need for revision surgery. Upper thoracic scoliosis was corrected by a mean 68.2% (38% to 48%, p < 0.001). Main thoracic scoliosis was corrected by a mean 71% (43.5% to 8.9%, p < 0.001). Lumbar scoliosis was corrected by a mean 72.3% (41% to 90%, p < 0.001). No patient lost more than 3° of correction at follow-up. The thoracic kyphosis improved by 13.1° (-21° to 49°, p < 0.001); the lumbar lordosis remained unchanged (p = 0.58). Coronal imbalance was corrected by a mean 98% (0% to 100%, p < 0.001). Sagittal imbalance was corrected by a mean 96% (20% to 100%, p < 0.001). The Scoliosis Research Society Outcomes Questionnaire score improved from a mean 3.6 to 4.6 (2.4 to 4, p < 0.001); patient satisfaction was a mean 4.9 (4.8 to 5). . Conclusions. This technique carries low neurological and vascular risks because the screws are placed in the pedicles of the convex side of the curve, away from the spinal cord, cauda equina and the aorta. A low implant density (pedicle screw density 1.2, when a density of 2 represents placement of pedicle screws bilaterally at every instrumented segment) achieved satisfactory correction of the scoliosis, an improved thoracic kyphosis and normal global sagittal balance. Both patient satisfaction and functional outcomes were excellent. Cite this article: Bone Joint J 2017;99-B:1080–7

Aims. The aim of this study is to introduce and investigate the efficacy and feasibility of a new vertebral osteotomy technique, vertebral column decancellation (VCD), for rigid thoracolumbar kyphotic deformity (TLKD) secondary to ankylosing spondylitis (AS). . Patients and Methods. We took 39 patients from between January 2009 and January 2013 (26 male, 13 female, mean age 37.4 years, 28 to 54) with AS and a TLKD who underwent VCD (VCD group) and compared their outcome with 45 patients (31 male, 14 female, mean age 34.8 years, 23 to 47) with AS and TLKD, who underwent pedicle subtraction osteotomy (PSO group), according to the same selection criteria. The technique of VCD was performed at single vertebral level in the thoracolumbar region of AS patients according to classification of AS kyphotic deformity. Pre- and post-operative chin-brow vertical angle (CBVA), sagittal vertical axis (SVA) and sagittal Cobb angle in the thoracolumbar region were reviewed in the VCD and PSO groups. Intra- , post-operative and general complications were analysed in both group. Results. lf patients could lie on their backs and walk with horizontal vision and sagittal profile, radiographic parameters improved significantly post-operatively in both groups. No major acute complications such as death or complete paralysis occurred in either group. In the VCD group, five patients (12.8%) experienced complications such as severe CSF leak (n = 4), deep wound infection (n = 1) and in one patient a transient neurological deficit occurred. In the PSO group, eight patients (17.8%) suffered conditions such as severe CSF leak (n = 5), infections (n = 2) and sagittal translation at osteotomy site (n = 1). Scoliosis Research Society outcomes instrument (SRS-22) improved significantly in both groups. All patients achieved solid fusion at latest follow-up and no implant failures were noted in either group. Take home message: The VCD technique is a new, safe and effective strategy for correction of rigid TLKD in AS patients. The main advantage of the new correction mechanism is that it achieved a satisfactory correction by controlled anterior column opening and posterior column closing, avoiding the occurrence of sagittal translation. Cite this article: Bone Joint J 2016;98-B:672–8

Aims

The direct posterior approach with subperiosteal dissection of the paraspinal muscles from the vertebrae is considered to be the standard approach for the surgical treatment of adolescent idiopathic scoliosis (AIS). We investigated whether or not a minimally-invasive surgery (MIS) technique could offer improved results.

There are few reports of the treatment of lumbar tuberculous spondylitis using the posterior approach. Between January 1999 and February 2004, 16 patients underwent posterior lumbar interbody fusion with autogenous iliac-bone grafting and pedicle screw instrumentation. Their mean age at surgery was 51 years (28 to 66). The mean follow-up period was 33 months (24 to 48). The clinical outcome was assessed using the Frankel neurological classification and the Kirkaldy-Willis criteria. On the Frankel classification, one patient improved by two grades (C to E), seven by one grade, and eight showed no change. The Kirkaldy-Willis functional outcome was classified as excellent in eight patients, good in five, fair in two and poor in one. Bony union was achieved within one year in 15 patients. The mean pre-operative lordotic angle was 27.8° (9° to 45°) which improved by the final follow-up to 35.8° (28° to 48°). Post-operative complications occurred in four patients, transient root injury in two, a superficial wound infection in one and a deep wound infection in one, in whom the implant was removed. Our results show that a posterior lumbar interbody fusion with autogenous iliac-bone grafting and pedicle screw instrumentation for tuberculous spondylitis through the posterior approach can give satisfactory results

Aims

The aim of this study was to compare the outcomes of surgery using growing rods in patients with severe versus moderate early-onset scoliosis (EOS).

Aims

The purpose of this retrospective study was to investigate the clinical relevance of increased facet joint distraction as a result of anterior cervical decompression and fusion (ACDF) for trauma.

Aims

The aim of this study was to report a retrospective, consecutive series of patients with adolescent idiopathic scoliosis (AIS) who were treated with posterior minimally invasive surgery (MIS) with a mean follow-up of two years (sd 1.4; 0.9 to 0 3.7). Our objectives were to measure the correction of the deformity and record the peri-operative morbidity. Special attention was paid to the operating time (ORT), estimated blood loss (EBL), length of stay (LOS) and further complications.

Aims

The primary aim of this study was to evaluate the performance and safety of magnetically controlled growth rods in the treatment of early onset scoliosis. Secondary aims were to evaluate the clinical outcome, the rate of further surgery, the rate of complications, and the durability of correction.

Aims

Magnetically controlled growing rods (MCGRs) allow non-invasive correction of the spinal deformity in the treatment of early-onset scoliosis. Conventional growing rod systems (CGRS) need repeated surgical distractions: these are associated with the effect of the ‘law of diminishing returns’.

The primary aim of this study was to quantify this effect in MCGRs over sequential distractions.

Aims

To evaluate the incidence of primary venous thromboembolism (VTE), epidural haematoma, surgical site infection (SSI), and 90-day mortality after elective spinal surgery, and the effect of two protocols for prophylaxis.

Aims

The aims of this study were to evaluate the clinical and radiological outcomes of instrumented posterolateral fusion (PLF) performed in patients with rheumatoid arthritis (RA).

Aims

Clinical and radiological data were reviewed for all patients with mucopolysaccharidoses (MPS) with thoracolumbar kyphosis managed non-operatively or operatively in our institution.

Aims

This study aimed to determine the relationship between pedicle-lengthening distance and bulge-canal volume ratio in cases of lumbar spinal stenosis, to provide a theoretical basis for the extent of lengthening in pedicle-lengthening osteotomies.

We compared the clinical, radiological and quality-of-life outcomes between hybrid and total pedicle screw instrumentation in patients undergoing surgery for neuromuscular scoliosis. A matched comparison using prospectively collected data was undertaken. A total of 66 patients underwent posterior or anteroposterior correction and fusion with hybrid (n = 33, mean age at surgery 15.8 years (9.10 to 19.6)) or total pedicle screw instrumentation (n = 33, mean age 14.7 years (7.0 to 20.7)) with a minimum follow-up of two years. The major curve pre-operatively was a mean of 87° (sd 29, 25° to 141°) and 81° (sd 18, 47° to 116°) in the hybrid and total pedicle screw groups, respectively (p = 0.29) and at a minimum of two years it was 33° (sd 20; 2° to 87°) and 20° (sd 12; 1° to 55°), respectively (p = 0.0016). The mean correction of the major curve was 59% (41% to 88%) in the hybrid and 75% (43% to 99%) in the total pedicle screw groups at two-year follow-up (p = 0.0011). The mean operating time was 7.45 hours (sd 2.18) and 6.04 hours (sd 1.71) in the hybrid and total pedicle screw groups, respectively (p = 0.001), and the mean intra-operative blood loss was 3760 ml (sd 2790) and 1785 ml (sd 1110), respectively (p = 0.001).

Total pedicle screw instrumentation provided shorter operating times, less blood loss and better correction of the major curve compared with hybrid constructs in patients undergoing surgery for neuromuscular scoliosis.

We reviewed 212 consecutive patients with adolescent idiopathic scoliosis who underwent posterior spinal arthrodesis using all pedicle screw instrumentation in terms of clinical, radiological and Scoliosis Research Society (SRS)-22 outcomes. In Group 1 (51 patients), the correction was performed over two rods using bilateral segmental pedicle screws. In Group 2 (161 patients), the correction was performed over one rod using unilateral segmental pedicle screws with the second ^{rod providing stability of the construct through two-level screw fixation at proximal and distal ends. The mean age at surgery was 14.8 years in both groups. Comparison between groups showed no significant differences with regard to age and Risser grade at surgery, pre- and post-operative scoliosis angle, coronal Cobb correction, length of hospital stay and SRS scores. Correction of upper thoracic curves was significantly better in Group 1 (p = 0.02). Increased surgical time and intra-operative blood loss was recorded in Group 1 (p < 0.001 and p = 0.04, respectively). The implant cost was reduced by mean 35% in Group 2 due to the lesser number of pedicle screws.}

Unilateral and bilateral pedicle screw techniques have both achieved excellent deformity correction in adolescent patients with idiopathic scoliosis, which was maintained at two-year follow-up. This has been associated with high patient satisfaction and low complication rates.

Posterior lumbar interbody fusion (PLIF) is indicated for many patients with pain and/or instability of the lumbar spine. We performed 36 PLIF procedures using the patient’s lumbar spinous process and laminae, which were inserted as a bone graft between two vertebral bodies without using a cage. The mean lumbar lordosis and mean disc height to vertebral body ratio were restored and preserved after surgery. There were no serious complications.

These results suggest that this procedure is safe and effective.

Transarticular screw fixation with autograft is an established procedure for the surgical treatment of atlantoaxial instability. Removal of the posterior arch of C1 may affect the rate of fusion. This study assessed the rate of atlantoaxial fusion using transarticular screws with or without removal of the posterior arch of C1. We reviewed 30 consecutive patients who underwent atlantoaxial fusion with a minimum follow-up of two years. In 25 patients (group A) the posterior arch of C1 was not excised (group A) and in five it was (group B). Fusion was assessed on static and dynamic radiographs. In selected patients CT imaging was also used to assess fusion and the position of the screws. There were 15 men and 15 women with a mean age of 51.2 years (23 to 77) and a mean follow-up of 7.7 years (2 to 11.6). Stable union with a solid fusion or a stable fibrous union was achieved in 29 patients (97%). In Group A, 20 patients (80%) achieved a solid fusion, four (16%) a stable fibrous union and one (4%) a nonunion. In Group B, stable union was achieved in all patients, three having a solid fusion and two a stable fibrous union. There was no statistically significant difference between the status of fusion in the two groups. Complications were noted in 12 patients (40%); these were mainly related to the screws, and included malpositioning and breakage. The presence of an intact or removed posterior arch of C1 did not affect the rate of fusion in patients with atlantoaxial instability undergoing C1/C2 fusion using transarticular screws and autograft.

Cite this article: Bone Joint J 2013;95-B:972–6.

Between March 2000 and February 2006, we carried out a prospective study of 100 patients with a low-grade isthmic spondylolisthesis (Meyerding grade II or below), who were randomised to receive a single-level and instrumented posterior lumbar interbody fusion with either one or two cages. The minimum follow-up was for two years. At this stage 91 patients were available for review. A total of 47 patients received one cage (group 1) and 44 two cages (group 2). The clinical and radiological outcomes of the two groups were compared.

There were no significant differences between the two groups in terms of post-operative pain, Oswestry Disability Score, clinical results, complication rate, percentage of post-operative slip, anterior fusion rate or posterior fusion rate. On the other hand, the mean operating time was 144 minutes (100 to 240) for patients in group 1 and 167 minutes (110 to 270) for those in group 2 (p = 0.0002). The mean blood loss up to the end of the first post-operative day was 756 ml (510 to 1440) in group 1 and 817 ml (620 to 1730) in group 2 (p < 0.0001).

Our results suggest that an instrumented posterior lumbar interbody fusion performed with either one or two cages in addition to a bone graft around the cage has a low rate of complications and a high fusion rate. The clinical outcomes were good in most cases, regardless of whether one or two cages had been used.

Inflammatory markers such as the C-reactive protein (CRP), white blood cell count and body temperature are easy to measure and are used as indicators of infection. The way in which they change in the early post-operative period after instrumented spinal surgery has not been reported in any depth.

We measured these markers pre-operatively and at one, four, seven and 14 days postoperatively in 143 patients who had undergone an instrumented posterior lumbar interbody fusion.

The CRP proved to be the only sensitive marker and had returned to its normal level in 48% of patients after 14 days. The CRP on day 7 was never higher than that on day 4. Age, gender, body temperature, operating time and blood loss were not related to the CRP level. A high CRP does not in itself suggest infection, but any increase after four days may presage infection.

We report the results of vertebral column resection (VCR) for paediatric patients with spinal deformity. A total of 49 VCRs in paediatric patients from four university hospitals between 2005 and 2009 with a minimum two-year follow-up were retrospectively identified. After excluding single hemivertebral resections (n = 25) and VCRs performed for patients with myelomeningocele (n = 6), as well as spondylectomies performed for tumour (n = 4), there were 14 patients who had undergone full VCR at a mean age of 12.3 years (6.5 to 17.9). The aetiology was congenital scoliosis in five, neuromuscular scoliosis in three, congenital kyphosis in two, global kyphosis in two, adolescent idiopathic scoliosis in one and secondary scoliosis in one. A total of seven anteroposterior and seven posterolateral approaches were used.

The mean major curve deformity was 86° (67° to 120°) pre-operatively and 37° (17° to 80°) at the two-year follow-up; correction was a mean of 54% (18% to 86%) in the anteroposterior and 60% (41% to 70%) in the posterolateral group at the two-year follow-up (p = 0.53). The mean Scoliosis Research Society-24 total scores were 100 (92 to 108) for the anteroposterior and 102 (95 to 105) for the posterolateral group. There was one paraparesis in the anteroposterior group necessitating urgent re-decompression, with a full recovery.

Patients undergoing VCR are highly satisfied after a successful procedure.

Between 1993 and 2008, 41 patients underwent total coccygectomy for coccydynia which had failed to respond to six months of conservative management. Of these, 40 patients were available for clinical review and 39 completed a questionnaire giving their evaluation of the effect of the operation. Excellent or good results were obtained in 33 of the 41 patients, comprising 18 of the 21 patients with coccydynia due to trauma, five of the eight patients with symptoms following childbirth and ten of 12 idiopathic onset. In eight patients the results were moderate or poor, although none described worse pain after the operation. The only post-operative complication was superficial wound infection which occurred in five patients and which settled fully with antibiotic treatment. One patient required re-operation for excision of the distal cornua of the sacrum.

Total coccygectomy offered satisfactory relief of pain in the majority of patients regardless of the cause of their symptoms.

We studied 15 patients with healed tuberculosis of the spine and a resultant kyphosis. We selected only those with no neurological deficit and performed a wedge resection of the vertebra using a transpedicular approach. The wedge was removed from the apex of the deformity. For those with a neurological deficit, we chose the conventional anterior debridement and decompression with 360° circumferential fusion. At a mean follow-up of 26.8 months (8 to 46) the outcome was good with an increase in the mean Oswestry Disability Index from 56.26 (48 to 62) pre-operatively to 11.2 (6 to 16) at the latest follow-up.

We reviewed 15 consecutive patients, 11 women and four men, with a mean age of 48.7 years (37.3 to 62.6), who between July 2004 and August 2007 had undergone percutaneous sacroiliac fusion using hollow modular anchorage screws filled with demineralised bone matrix.

Each patient was carefully assessed to exclude other conditions and underwent pre-operative CT and MR scans. The diagnosis of symptomatic sacroiliac disease was confirmed by an injection of local anaesthetic and steroid under image intensifier control.

The short form-36 questionnaire and Majeed’s scoring system were used for pre- and post-operative functional evaluation. Post-operative radiological evaluation was performed using plain radiographs.

Intra-operative blood loss was minimal and there were no post-operative clinical or radiological complications. The mean follow-up was for 17 months (9 to 39). The mean short form-36 scores improved from 37 (23 to 51) to 80 (67 to 92) for physical function and from 53 (34 to 73) to 86 (70 to 98) for general health (p = 0.037). The mean Majeed’s score improved from 37 (18 to 54) pre-operatively to 79 (63 to 96) post-operatively (p = 0.014). There were 13 good to excellent results. The remaining two patients improved in short form-36 from a mean of 29 (26 to 35) to 48 (44 to 52). Their persistent pain was probably due to concurrent lumbar pathology.

We conclude that percutaneous hollow modular anchorage screws are a satisfactory method of achieving sacroiliac fusion.

This review of the literature presents the current understanding of Scheuermann’s kyphosis and investigates the controversies concerning conservative and surgical treatment. There is considerable debate regarding the pathogenesis, natural history and treatment of this condition. A benign prognosis with settling of symptoms and stabilisation of the deformity at skeletal maturity is expected in most patients. Observation and programmes of exercise are appropriate for mild, flexible, non-progressive deformities. Bracing is indicated for a moderate deformity which spans several levels and retains flexibility in motivated patients who have significant remaining spinal growth.

The loss of some correction after the completion of bracing with recurrent anterior vertebral wedging has been reported in approximately one-third of patients. Surgical correction with instrumented spinal fusion is indicated for a severe kyphosis which carries a risk of progression beyond the end of growth causing cosmetic deformity, back pain and neurological complications. There is no consensus on the effectiveness of different techniques and types of instrumentation. Techniques include posterior-only and combined anteroposterior spinal fusion with or without posterior osteotomies across the apex of the deformity. Current instrumented techniques include hybrid and all-pedicle screw constructs.

Anterior debridement, grafting of the defect and posterior instrumentation as a single-stage procedure is a controversial method of managing pyogenic vertebral osteomyelitis. Between 1994 and 2005, 37 patients underwent this procedure at our hospital, of which two died and three had inadequate follow-up. The remaining 32 were reviewed for a mean of 36 months (12 to 66). Their mean age was 48 years (17 to 68). A significant pre-operative neurological deficit was present in 13 patients (41%). The mean duration of surgery was 285 minutes (240 to 360) and the mean blood loss was 900 ml (300 to 1600). Pyogenic organisms were isolated in 21 patients (66%). All patients began to mobilise on the second post-operative day. The mean hospital stay was 13.6 days (10 to 20). Appropriate antibiotics were administered for 10 to 12 weeks. Early wound infection occurred in four patients (12.5%), and late infection in two (6.3%).

At final follow-up, the infection had resolved in all patients, neurological recovery was seen in ten of 13 (76.9%) and interbody fusion had occurred in 30 (94%). The clinical outcome was excellent or good in 30 patients according to Macnab’s criteria.

This surgical protocol can be used to good effect in patients with pyogenic vertebral osteomyelitis when combined with appropriate antibiotic therapy.

Between January 1990 and December 2000 we carried out 226 SB Charité III disc replacements for lumbar disc degeneration in 160 patients. They were reviewed at a mean follow-up of 79 months (31 to 161) to determine the clinical and radiological outcome. The clinical results were collected by an independent observer, who was not involved in patient selection, treatment or follow-up, using a combination of outcome measures, including the Oswestry Disability Index. Pain was recorded using a visual analogue score, and the most recent radiographs were reviewed.

Survival of the device was analysed by the Kaplan-Meier method and showed a cumulative survival of 35% at 156 months when radiological failure was taken as the endpoint. The mean improvement in the Oswestry disability index scores after disc replacement was 14% (6% to 21%) and the mean improvement in the pain score was 1.6 (0.46 to 2.73), both falling below the clinically significant threshold. Removal of the implant was required in 12 patients, four because of implant failure.

These poor results indicate that further use of this implant is not justified.