Soon, UK surgeons will need to undergo regular revalidation and relicensing. As a part of this process they will need to collect accurate outcomes data. However, a lack of standardisation has led to numerous generic and disease specific outcome tools being available with increasing complexity in their administration and interpretation. In research and university settings these tools are easily administered, but in a busy general spinal practice with limited human and time resources, it may not be possible to use them reliably and consistently. Web-based systems remove some of these problems, but data-input can be time consuming.

This study evaluates the utility of a subjective Patient Satisfaction Evaluation Questionnaire (PSE) by comparing it to well-known outcome tools, the Oswestry disability Index (ODI) and the Low Back Outcome Score (LBOS).

The PSE (modified Odom’s Criteria) evaluates pain, the willingness to undergo surgery again in similar circumstances, the likelihood of recommending the operation undergone to a friend or family member and satisfaction with the process of care. Pain relief is ranked as “complete”, “good but not complete”, “little” or “no pain relief/pain worse than before surgery”. The responses are scored with three points allocated to complete relief of pain, down to none for no relief. The other questions score one for a positive and zero for a negative response. The maximum score is six. Four, five or six points count as success as long as the pain component is two or three. Nought to three, counts as failure, as does a score of four when pain is rated as “poor”.

The ODI, LBOS and PSE are not directly numerically comparable, but the results of them all can be grouped into “Success” and “Failure” which gives a basis for comparison of the tools.

150 consecutive patients who underwent lumbar spine surgery completed the three questionnaires independently of the treating surgeon. The scores were subjected to regression analysis (R square) and a Pearson’s correlation. Feedback was sought from the patients regarding the “user friendliness” of the questionnaires.

Results showed a good correlation between the ODI and LBOS with a Pearson’s value and R Square (RSQ) value of 0.86 and 0.75 respectively. The PSE compared to the ODI showed a Pearson’s value of 0.86 and RSQ of 0.74. The LBOS and PSE comparison had a Pearson’s value of 0.78 and RSQ of 0.61. The results show that the PSE in the form used correlates well with results from the ODI and LBOS. However, the patient feedback data indicated that the PSE was the most user friendly of the three tools.

The PSE was found to be a useful and user friendly tool, correlating well with recognised outcome measures, being easy to administer, document and interpret. If surgeons with limited resources cannot reliably use a more rigorous outcome tool, using the PSE should provide enough data to meet the standards that are likely to be required for revalidation and relicensing.

Introduction: Europe has no equivalent of the US Food and Drug Administration (FDA). As a result, spinal implants can be adopted into clinical use in Europe earlier than in the US with a lesser regulatory burden. This may benefit patients, but if a device fails due to design changes that are not fully evaluated, outcomes can be compromised. The classic example in the past was the Capital Hip. If Europe had an equivalent to the FDA, oversight of implant design and design changes might prevent such occurrences.

The Prosthetic Disc Nucleus (PDN) is an implant designed to replace the nucleus of the lumbar disc in early stage symptomatic disc degeneration. The PDN originally was a paired device. Due to technical difficulties encountered by surgeons these were converted to a single implant (PDN Solo range). Mechanical testing suggested the new device would function as well as the original paired device. However, the implant was introduced into clinical practice, outside of the US, without any clinical evaluation.

Study Design: Prospective cohort study with 3 to 5 year clinical and radiological follow-up.

Objective of Study: To review the outcome of PDN Solo implanted anteriorly in the lumbar spine, define the mode of failure and describe revision strategies.

Patients and Methods: PDN Solo was used in 35 patients from September 2002 to January 2005 with a median follow-up of 49 months. Patients with discogenic back pain causing significant disability were offered nucleus replacement after an extensive process of consent. The approach was anterior retroperitoneal with the exception of L5/S1 which was transperitoneal. 17 patients were treated with PDN alone and 18 with a PDN to treat a degenerate level adjacent to an interbody fusion. Outcome measures were the Low Back Outcome Score and a Patient Satisfaction Evaluation.

Results: 14 patients have needed PDN revision. The mean time to failure was 16.5 months. There were three early extrusions, two replaced with PDNs and one converted to a fusion. Revision procedures included seven conversions to STALIF, two circumferential fusions and five posterolateral fusions.

Four more unrevised patients were identified as clinical failures. The total failure rate was therefore 51.4%. In patients with a successful outcome there was a 33 point improvement in the mean LBOS score.

In all cases of failure the PDN jacket became disrupted with concomitant fragmentation of the hydrogel core

Conclusions: Modification of the paired PDN to a single device was introduced outside the US without any clinical evaluation. In the US, the original PDN and the Solo version failed to gain regulatory approval and following the failure of the Solo it has been redesigned again. This study raises questions regarding implant design, testing and approval considering that more than 4500 PDN replacements have been carried out worldwide since 1996. Do these events call for a European equivalent to the FDA?

Objective: To evaluate the outcome of treatment for adolescent disc disease (ADD) in individuals regularly involved in high class sport compared to relatively more sedentary adolescents.

Design: Retrospective observational study.

Setting: Private Spinal Orthopaedic Practice.

Patients: 52 individuals with confirmed ADD. 25 competing at county or national level in various sports (Group A). 27 moderately active individuals (Group B), but not elite sports players.

Interventions: History and clinical examination followed by radiological investigations were performed. Both groups were treated with oral medication including simple analgesia, muscle relaxants and NSAIDs as well as physiotherapy. Those with persistent pain were referred for pain management. Surgery was considered for refractory cases.

Main outcome measurements: The clinical and radiological evidence of disease progression, need for minimally invasive and invasive treatments as well as return to previous level of sport.

Results: 11 patients (44%) in group A had a non-invasive programme of treatment based on intensive physiotherapy. 11 (44%) needed minimally-invasive treatments in addition to physiotherapy. Three patients (12%) required surgery. One patient had to give up elite sport because of recurrent pain on significant exercise, but the others resumed their previous level of activity.

Nine patients (33%) in Group B were treated by physiotherapy alone while 13 (48%) had minimally-invasive treatment in addition to physiotherapy. Five patients (18.5%) required surgery. Two patients required revision surgery. All patients returned to their normal level of sporting activity.

Conclusion: Adolescents who play sport at a high level should not be discouraged by a diagnosis of ADD, as the outcomes of treatment are at least no worse than in their less active counterparts.