Objective

To determine if there is a differing effect between two spinal implant systems on sagittal balance and thoracic kyphosis in adolescent idiopathic scoliosis.

Introduction The aim of this study was to assess the safety and effectiveness of the Wallis Stabilization System through a prospective international multi-center study.

Methods 262 consecutive patients (39% female, 61% male; mean age of 44 years), treated with the Wallis system, were enrolled into the study, which was undertaken in 8 centers in 6 countries. The two principal indications for surgery were massive disc herniation (37% patients) and degenerative disc disease with Modic type 1 change (27% patients).

Clinical outcomes variables, assessed preoperatively and at 3, 6, 12 and 24 months, included the Japanese Orthopaedic Association score (JOA) for low back pain, SF-36, lumbar and leg pain visual analog scale (VAS), and Odom score. At these assessments flexion/extension radiographs were performed and yearly MRIs have been obtained.

Results Mean time of surgery overall was 74 minutes, with an average of 19 minutes required for implantation. Average blood loss was 180 cc.

Pre-operatively, the mean VAS was 70.3/100. At three months, VAS was significantly reduced (P< 0.01) to a mean 18.3 with further reductions to 17.0 at 6 months and 14.6 at 24 months. At 3 months post-operation, all categories of the SF-36 scores (except general health) had shown significant improvement compared with preoperative values. At 1 year, and sustained at 2 years, the SF-36 scores were comparable with an aged and sex matched normal population form France. The JOA score (15 point scale) significantly improved (P< 0.01) from 6.0 preoperatively to 12.9 at 24 months after reaching a plateau at 3 months (12.5).

From Odom’s assessment at 3 months 85% of subjects were categorized as ‘good’ or ‘excellent’, this being sustained over the period of the study, with results at 6 months and 24 months 90% and 88%, respectively.

Of the total cohort of 262 cases, only four implant-related failures have been observed to date.

Discussion The objective of the study was to determine the safety and efficacy of the Wallis stabilization system in treating symptomatic degenerative lumbar motion segments. The medium term results at 2 years have been very encouraging, with the significant clinical improvement seen at 1 year being sustained through to 2 years. This, coupled with the survivorship analysis for the first generation implant, give grounds for optimism for the future.

The few implant related failures all occurred in the first year, after which some minor implant modifications were made. There have been no subsequent implant related failures.

Introduction: Peridural fibrosis is a reaction that occurs outside the dura and occurs in the healing process following lumber surgery¹.The fibrosis is recognised as one of the possible causes of the failed back syndrome following lumbar spinal surgery. ADCON-L Anti-Adhesion Barrier Gel has been shown to be of Benefit in patients undergoing discectomy in reducing symptomatic fibrosis. The aim of this prospective study is to elicit the advantages and potential risks of using ADCON-L in more extensive decompression procedures and in instrumented spinal fusions.

Method: ADCON-L anti-adhesion barrier gel, has been used in 288 patients undergoing the following surgeries: posterior lumbar interbody fusion (PLIF) (49), decompression and instrumented fusion posterior interbody supplementary fixation (PISF) (96), decompression and Graf ligament stabilisation (31), decompression of stenosis (54), discectomy (41), and revision discectomy or decompression (17). Any adverse clinical events, including pseudarthrosis, new, recurrent or deteriorating leg pain, paraesthesia or neurological deficit, were documented. Patients with neurological symptoms suggestive of fibrosis including deteriorating leg pain were evaluated with an MRI scan with gadolinium enhancement. Fusion rates were evaluated where appropriate.

Results: Two patients developed significant early (< 4 weeks) recurrent sciatica. MRI demonstrated a recurrent disc prolapse at the same level in one patient, who required re-operation, but no fibrosis was noted at the surgery. Late developing leg pain occurred in 16 patients. All these patients were evaluated with MRI with gadolinium enhancement. Independent radiological assessment indicated the principal cause of the leg pain to be peridural fibrosis in 9 patients (3.1%). Other causes included recurrent disc prolapse or lateral recess stenosis. Early post-operative wound seepage or superficial wound infections occurred in 5 (1.7%). There were no late infections. Two patients developed a postoperative pseudomeningocoele. One required re-exploration and repair, the other settled with conservative treatment. At review 1 to 4 years (mean 2.7 years) after undergoing PISF and PLIF fusion had achieved in 93.1% of cases.

Discussion: Previous prospective randomised multi-centre studies have shown the effectiveness of ADCON-L gel in reducing peridural fibrosis in patients following discectomy. Our study shows that there is low incidence of peridural fibrosis and associated leg pain when ADCON-L is used in all forms of degenerative lumbar spine surgery. There is a low complication rate and good fusion rate.

Introduction: The Wallis implant was developed as a minimally invasive and anatomically conserving method of addressing the various biomechanical derangements associated with lumbar degenerative changes without recourse to rigid fixation.¹ The Wallis implant evolved from successful clinical experience in over 300 patients with a first generation implant, supported by detailed biomechanical and finite element studies. These demonstrated that the implant improves the stability of the degenerate motion segment, reduces loads transmitted through the intervertebral disc and facet joints and improves the dimensions of the spinal canal, lateral recesses and root foramina. The purpose of the present ongoing study is to demonstrate the tolerance of this implant and its efficacy against low back pain and functional disability in patients with degenerative disc disease.

Methods: A prospective multi-centre international observational study was commenced 2 years ago. The inclusion criteria were degenerative disc disease without disc herniation, recurrence of herniated disc, voluminous herniated disc (corresponding to a complete loss of the nucleus) and herniated disc accompanying the transitional anomaly, sacralisation of L5. Assessment includes SF-36, JOA, VAS and Oswestry Disability Index, and all patients undergo pre-operative radiographs and MRI scans with interval radiographs and scans post-operatively. The study will be continued for a minimum of five years.

Results: Thus far 210 patients have been recruited and 1-year review is available for 51. Preliminary 1-year results confirm the clinical efficacy of this procedure in the management of low back pain and as an adjunct in the treatment of radicular and stenotic symptoms. Furthermore, in some instances MRI evaluation has shown re-hydration of the disc nucleus.

Discussion: The procedure involves no additional exposure or muscle dissection compared with simple flavectomy decompression. The supraspinous ligament and facet joints are preserved and no bony fixation is required. As such the procedure can potentially be reversed and all options for future procedures, if required, are preserved. There is no adverse effect on adjacent segments.

Objective: To assess the cardiology of continuous ECG of Spinal Surgeons performing complex spinal deformity surgery.

Design: Spinal surgeons were attached to 24 hour tape ECG monitors while performing spinal deformity surgery. Pre op, intra-op and immediate post op assessment were performed.

Subjects: 4 Consultants 1 Spinal Fellow

Outcome measures: ECG changes, Heart Rate variance and Heart Rate

Results: Variability in Heart rate was related to the experience of the surgeon and the case performed.

Heart rate variance was highest in the Consultant with the most recent appointment. Heart rate variance in the Trainee was the lowest. The highest heart rate was achieved when scrubbed supervising the surgical trainee. The surgeons with the highest deformity work load had the lowest intra-operative heart rate

Conclusions: Spinal deformity surgery is stressful to the Consultant performing the case. Experience and case mix affect these findings. The highest stress rate occurs with supervising trainees.

To compare the effectiveness of ALIF, using the Hartshill Horseshoe cage, and Graf ligamentoplasty for stabilisation of comparable severity of degenerative disc disease.

Between 1995 and 1997, 27 patients who had single level ALIF with Hartshill Horseshoe cage [group A], and 28 patients who had single level Graf ligamentoplasty [group B] were assessed by Oswestry disability index, a subjective score, Zung Depression Scale [ZDS], and Modified Somatic Perception Questionnaire [MSPQ]. The two groups were similar in age and sex distribution. The patients were randomized, and procedures were all undertaken primarily for symptoms of back pain, although some patients in each group reported some leg pain. No patients with the ALIF group had any MRI evidence of neurological compromise. Where there was any degeneration at more than 1 level, discography was undertaken (8 patients in each group) confirming an isolated pain source at a single level. The duration of back symptoms and leg symptoms in the two groups was similar. There was some difference in the distribution of the MRI grade of disc degeneration between the 2 groups, but this did not reach statistical significance. Following is the characteristic of the 2 groups:

In this group, Graf ligamentoplasty procedure had a statistically significant better outcome than ALIF with the Hartshill horseshoe cage.

This may be due to the retention of some degree of normal mobility of the affected segments after stabilisation with Graf ligaments. However, at a minimum follow-up of 2 years, these represent only medium term results. There is a potential for a change in the outcome in the long term.

We report the preliminary results of a continuing prospective evaluation of a screening programme for congenital dislocation of the hip (CDH) which uses ultrasound imaging to provide delayed selective screening to complement neonatal clinical screening. Of 26,952 births in the Southampton district, 1894 infants were referred for secondary screening because of a clinical abnormality or the presence of a predetermined risk category for CDH. Pavlik harness treatment was required for only 118 infants, giving a treatment rate of 4.4 per 1000 births. Of those referred with clinical instability, 35% did not require treatment. Dislocation or subluxation was detected in 17 of 643 infants referred only because they fell within one of three risk categories: breech presentation, foot deformity and family history. All 17 had normal clinical examinations and cases were discovered in each category. Six children presented with CDH after 12 weeks of age, giving a late presentation rate of 0.22 per 1000 births. All had normal clinical examinations within 24 hours of birth and none was in a risk category. Surgery has been required in ten children, giving a surgical treatment rate of 0.37 per 1000 births. We conclude that, in Southampton, delayed selective secondary screening with ultrasound is more effective than clinical screening alone. It targets treatment to those infants who need it, and reveals a number of dislocated and subluxed hips that would otherwise be missed.

We investigated 133 knees with suspected meniscal or cruciate injuries by magnetic resonance imaging, and compared the findings with those at arthroscopy. MRI was found to be highly sensitive, specific and accurate in the evaluation of the menisci and the anterior cruciate ligament.