Background

Depression, anxiety, catastrophising, and fear-avoidance beliefs are some of the so-called “yellow flags” that predict a poor outcome in back patients. Many surgeons have difficulty assessing yellow flags, perhaps due to the complexity of existing instruments and time constraints during consultations. We developed a brief tool to allow the systematic evaluation of core flags.

Background

Patient-rated measures are the gold standard for assessing spine surgery outcomes, but there is no consensus on the appropriate timing of follow-up. Journals often demand a minimum 2-year follow-up, but the indiscriminate application of this principle may not be warranted. We examined the course of change in patient outcomes up to 5 years postoperatively.

Purpose

A new approach to the reporting of health outcomes involves assessing the proportion of patients achieving a level of symptoms that they feel they could live with. We evaluated the acceptable level of pain in patients after surgery for lumbar disc herniation (LDH).

Background/Purpose of study

The increasing aging of the population will see a growing number of patients presenting for spine surgery with appropriate indications but numerous medical comorbidities. This complicates decision-making, requiring that the likely benefit of surgery (outcome) be carefully weighed up against the potential risk (complications). We assessed the influence of comorbidity on the risks and benefits of spine surgery.

Background

Recent years have witnessed a paradigm shift in the assessment of outcome in spine surgery, with patient-centred questionnaires replacing traditional surgeon-based assessments. The assessment of “complications” — loosely defined as new/unexpected problems arising as a result of surgery — has not enjoyed this same enlightened approach.

Introduction: Recent years have witnessed something of a paradigm shift in relation to the assessment of outcome in spine surgery: multidimensional patient-centred questionnaires have superseded the traditional surgeon-based rating of global outcome, and surgical registries have been developed to capitalise on the principle of “strength in numbers”. Interestingly, although recognised as a potential determinant of the patient’s view of the success of the surgery, the assessment of complications — in this context defined as new or unexpected problems arising as a result of surgery — has not enjoyed the same enlightened approach in relation to the patient’s perspective. The present study sought to fill this gap in the current array of outcome measures.

Methods: All German-speaking patients undergoing spinal surgery within our Spine Unit in the two years from Jan 2005 to Dec 2006 were asked to complete the patient-orientated Core-Measures-Index of the SSE Spine Tango Spine Surgery Registry 12 mo after surgery; the surgeon completed a Spine Tango surgery form and follow-up forms at various intervals up to 12 mo postop. In the patient questionnaire, the patient was asked “did any complications arise as a consequence of your operation 1 year ago (e.g. problems with wound healing, paralysis, sensory disturbances, etc.)? If so, give details.” Patients were also asked about their satisfaction with the operation and the global outcome of surgery.

Results: 2080/2259 (92%) patients returned a 12-month questionnaire. 28% patients answered “yes” to the complications question. This compares with complication rates of 3–10% recorded during the various Spine Tango Surgical follow-ups up to 12 months post-op. Patients sometimes listed “complications” that would rarely classify as such in the traditional sense; however, the incidence of their reported complications was significantly associated with outcome/satisfaction, suggesting they were not trivial to the patient. The more recent addition of a question concerning the “bothersomeness” of the reported complications revealed that 6% patients thought the complications were not at all bothersome; 21%, slightly bothersome; 30%, moderately bothersome; 27%, very bothersome and 16%, extremely bothersome.

Discussion: The results indicate that, just like outcome, “complications” should be assessed from both the patient’s and the surgeon’s perspectives, not least to better understand the reasons accounting for dissatisfaction and a poor patient-rated outcome.

Introduction A prospective, randomised, controlled study has been conducted to compare the clinical outcomes of patients treated with a Presige® artificial cervical disc (Medtronic Sofamor Danek, Memphis, TN) to patients who receive fusion after cervical discectomy for the treatment of primary cervical disc disease. It is hypothesized that maintenance of motion after anterior cervical discectomy will prevent the high rate of adjacent level premature degeneration. The primary purposes of the study are to (1) prove equivalence (non inferiority) of outcome of the disc prosthesis in the short term compared with fusion; and (2) to asses the ability of the prosthesis to maintain motion. Enrolment has closed and this is a report of the data with 50 cases with 6 month follow-up and 9 cases having reached 24 month final follow-up.

Methods In four centres, 52 patients with primary, single level cervical disc disease producing radiculopathy and/or myelopathy were randomised prospectively to receive anterior cervical discectomy with either fusion or artificial cervical disc replacement. The patients were evaluated with pre and postoperative serial flexion-extension cervical x-rays at 6 weeks, 3, 6, 12, and 24 months. At the same intervals, the patients had pre and postoperative neck disability indexes, visual pain analogue scales, European myelopathy scores, SF-36 general health scores, and neurological status examinations assessing the patient’s reflex, motor and sensory function.

Results At 6 weeks the neck disability index reduced by 34.1 for the investigational group compared to 35.2 for the fusion group. The improvement seen in the treatment groups was statistically equivalent (p < 0.05, non-inferiority margin = 10) up to the 24-month follow-up interval. The pain score had reduced by 7.7 for the investigational group and by 9.7 for the control group. Both groups improved statistically from preoperatively though statistical equivalence could not be shown. This improvement appeared to be maintained until the 12 month follow-up. Mean arm pain scores improved in both groups with statistical equivalence being demonstrated (p < 0.05, non-inferiority margin = 10). The adverse events in both groups were similar. Analysis of range motion showed a mean preoperative range of motion in the arthroplasty group of 5.9 degrees and 6.3 degrees in the fusion group. At twelve months the arthroplasty group had a mean range of motion of 5.9 degrees and the fusion group had a mean range of motion of 1.1 degrees

Discussion Anterior cervical discectomy and fusion has a good short term outcome though there is a high incidence of failure at adjacent levels over time. It is hypothesised that the maintenance of motion of a segment will prevent adjacent premature degeneration. It will take long term follow-up studies however to prove this. In the mean time, the justification to insert artificial cervical prostheses rests on being able to prove equivalence of outcome between fusion and prosthesis in the short term. This paper shows that, in the short to medium term, the clinical outcomes appear to be equivalent to fusion. And that range of motion is maintained.

Introduction: A prospective, randomized, controlled study has been conducted to compare the clinical outcomes of patients treated with an artificial cervical disc to patients who receive fusion after cervical discectomy for the treatment of primary cervical disc disease. It is hypothesized that maintenance of motion after anterior cervical discectomy will prevent the high rate of adjacent level premature degeneration. The primary purpose of the study is to prove equivalence (non inferiority) of outcome of the disc prosthesis in the short term compared with fusion. Enrolment has closed and this is a report of the data with 50 cases with 6 month follow-up and 9 cases having reached 24 month final follow-up.

Methods: In four centres, 52 patients with primary, single level cervical disc disease producing radiculopathy and/or myelopathy were randomised prospectively to receive anterior cervical discectomy with either fusion or artificial cervical disc replacement. The patients were evaluated with pre- and post-operative serial flexion-extension cervical x-rays at 6 weeks, 3, 6, 12, and 24 months. At the same intervals, the patients had pre and postoperative neck disability indexes, visual pain analogue scales, European myelopathy scores, SF-36 general health scores, and neurological status examinations assessing the patient’s reflex, motor and sensory function.

Results: At 6 weeks the neck disability index reduced by 34.1 for the investigational group compared to 35.2 for the fusion group. The pain score had reduced by 7.7 for the investigational group and by 9.7 for the control group. This improvement appeared to be maintained until the 12 month follow-up. The mean pain scores at 24 months were similar (4.3 and 5.6 respectively) In general there appeared to be a slightly better outcome for the investigational group, though the investigational group showed slightly less preoperative pain (p=0.091) and disability (p=0.055) than the fusion group. Both pain score and disability scores improved statistically significantly compared to the pre op scores (p< 0.001 all comparisons). Analysis of non-inferiority of outcome for the investigational group using ANCOVA with the preoperative score as the covariate and a non-inferiority margin of 5 points (5%) showed statistical significance at 12 weeks for Neck Disability Index.

Discussion: Anterior cervical discectomy and fusion has a good short-term outcome though there is a high incidence of failure at adjacent levels over time. It is hypothesized that the maintenance of motion of a segment will prevent adjacent premature degeneration. It will take long term follow-up studies however to prove this. In the mean time, the justification to insert artificial cervical prostheses rests on being able to prove equivalence of outcome between fusion and prosthesis in the short term. This paper shows that the outcomes appear to be equivalent. Though there is insufficient power to prove equivalence with a clinical margin of 5%.

Introduction: A prospective, randomized, controlled study has been conducted to compare the clinical outcomes of patients treated with an Artificial Cervical Disc to patients who receive fusion after cervical discectomy for the treatment of primary cervical disc disease. It is hypothesized that maintenance of motion after anterior cervical discectomy will prevent the high rate of adjacent level premature degeneration. The primary purpose of the study is to prove equivalence (non inferiority) of outcome of the disc prosthesis in the short term compared with fusion.

Methods: In four centers, 60 patients with primary, single level cervical disc disease producing radiculopathy and/or myelopathy are randomized prospectively to receive anterior cervical discectomy with either fusion or artificial cervical disc placement. The patients are evaluated with pre and postoperative serial flexion-extension cervical x-rays at 6 weeks, 3, 6, 12, and 24 months. At the same intervals, the patients have pre and postoperative neck disability indexes, visual pain analogue scales, European myelopathy scores, SF-36 general health scores, and neurological status examinations assessing the patient’s reflex, motor and sensory function.

Results: Data is presented for the first 47 patients. At 6 weeks the neck disability index reduced by 36.1 for the investigational group compared to 34.8 for the fusion group. The pain score had reduced by 8.2 for the investigational group and by 9.9 for the control group. This improvement appeared to be maintained until the 12 month followup. In general there appeared to be a slightly better outcome for the investigational group. Both pain score and disability scores improved statistically significantly compared to the pre op scores (p< 0.001 all comparisons). Analysis of non inferiority of outcome for the investigational group using ANCOVA with the preoperative score as the covariate and a non inferiority margin of 5 points showed statistical significance at 6 and 12 weeks for Neck disability index. Operative time appeared slightly less (2.3 hrs) for the investigational group compared to the fusion group(2.5hrs). Blood loss also appeared higher in the fusion group (165 mls compared to 91 mls). Hospital stay was equivalent (2.8 days and 2.9 days).

Discussion: Anterior cervical discectomy and fusion has a good short term outcome though there is a high incidence of failure at adjacent levels over time. It is hypothesized that the maintenance of motion of a segment will prevent adjacent premature degeneration. It will take long term followup studies however to prove this. In the mean time, the justification to insert artificial cervical prostheses rests on being able to prove equivalence of outcome between fusion and prosthesis in the short term. This paper shows that the outcomes appear to be equivalent. Early statistical evidence is available for some of the outcome measures at early post op followup. Further statistical power will be available when the full 60 cases are available for study and this may give further weight to the hypothesis of equivalence of outcome.

INTRODUCTION: A prospective, randomised, controlled study has been conducted to compare the clinical outcomes of patients treated with an Artificial Cervical Disc to patients who receive fusion after cervical discectomy for the treatment of primary cervical disc disease. It is hypothesised that maintenance of motion after anterior cervical discectomy will prevent the high rate of adjacent level premature degeneration. The primary purpose of the study is to prove equivalence (non inferiority) of outcome of the disc prosthesis in the short term compared with fusion.

METHODS: In four centres, 60 patients with primary, single level cervical disc disease producing radiculopathy and/or myelopathy are randomised prospectively to receive anterior cervical discectomy with either fusion or artificial cervical disc placement. The patients are evaluated with pre- and post-operative serial flexion-extension cervical X-rays at six weeks, three, six, 12, and 24 months. At the same intervals, the patients have pre- and post-operative neck disability indexes, visual pain analogue scales, European myelopathy scores, SF-36 general health scores, and neurological status examinations assessing the patient’s reflex, motor and sensory function.

RESULTS: Data are presented for the first 47 patients. At six weeks the neck disability index reduced by 36.1 for the investigational group compared to 34.8 for the fusion group. The pain score had reduced by 8.2 for the investigational group and by 9.9 for the control group. This improvement appeared to be maintained until the 12 month follow-up. In general there appeared to be a slightly better outcome for the investigational group. Both pain score and disability scores improved statistically significantly compared to the pre-operative scores (p< 0.001 all comparisons). Analysis of non inferiority of outcome for the investigational group using ANCOVA with the pre-operative score as the covariate and a non inferiority margin of five points showed statistical significance at six and 12 weeks for Neck disability index. Operative time appeared slightly less (2.3 hours) for the investigational group compared to the fusion group (2.5 hours). Blood loss also appeared higher in the fusion group (165 mls compared to 91 mls). Hospital stay was equivalent (2.8 days and 2.9 days).

DISCUSSION: Anterior cervical discectomy and fusion has a good short term outcome though there is a high incidence of failure at adjacent levels over time. It is hypothesised that the maintenance of motion of a segment will prevent adjacent premature degeneration. It will take long term follow-up studies however to prove this. In the meantime, the justification to insert artificial cervical prostheses rests on being able to prove equivalence of outcome between fusion and prosthesis in the short term. This paper shows that the outcomes appear to be equivalent. Early statistical evidence is available for some of the outcome measures at early post-operative follow-up. Further statistical power will be available when the full 60 cases are available for study and this may give further weight to the hypothesis of equivalence of outcome.

We carried out a retrospective review of 155 patients with lumbar spinal stenosis who had been treated surgically and followed up regularly: 77 were evaluated at a mean of 6.5 years (5 to 8) after surgery by two independent observers. The outcome was assessed using the scoring system of Roland and Morris, and the rating system of Prolo, Oklund and Butcher. Instability was determined according to the criteria described by White and Panjabi.

A significant decrease in low back pain and disability was seen. An excellent or good outcome was noted in 79% of patients; 9% showed secondary radiological instability.

Surgical decompression is a safe and efficient procedure. In the absence of preoperative radiological evidence of instability, fusion is not required.

We have developed criteria to determine the appropriate indications for lumbar laminectomy, using the standard procedure developed at the RAND corporation and the University of California at Los Angeles (RAND-UCLA). A panel of five surgeons and four physicians individually assessed 1000 hypothetical cases of sciatica, back pain only, symptoms of spinal stenosis, spondylolisthesis, miscellaneous indications or the need for repeat laminectomy. For the first round each member of the panel used a scale ranging from 1 (extremely inappropriate) to 9 (extremely appropriate). After discussion and condensation of the results into three categories laminectomy was considered appropriate in 11% of the 1000 theoretical scenarios, equivocal in 26% and inappropriate in 63%. There was some variation between the six categories of malalignment, but full agreement in 64% of the hypothetical cases.

We applied these criteria retrospectively to the records of 196 patients who had had surgical treatment for herniated discs in one Swiss University hospital. We found that 48% of the operations were for appropriate indications, 29% for equivocal reasons and that 23% were inappropriate.

The RAND-UCLA method is a feasible, useful and coherent approach to the study of the indications for laminectomy and related procedures, providing a number of important insights. Our conclusions now require validation by carefully designed prospective clinical trials, such as those which are used for new medical techniques.