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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 28 - 28
1 Oct 2019
Mannion A Mariaux F Porchet F Fekete T Jeszenszky D Haschtmann D Kleinstuck F Loibl M Elfering A
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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.

Methods

Data from 4 questionnaires (ZUNG depression (N=399); Hospital Anxiety and Depression Scale (Anxiety-subscale) (N=308); Pain Catastrophising (N=766); Fear Avoidance Beliefs (N=736)) were analysed to identify the respective single item that best represented the full scale score. The 4 items formed the “Core Yellow Flags Index” (CYFI). 1'768 patients completed CYFI and a Core Outcome Measures Index (COMI) preoperatively, and COMI 3 and 12mo later (FU).


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_10 | Pages 27 - 27
1 May 2017
Fekete T Haschtmann D Becker H Kleinstück F Porchet F Jeszenszky D Banczerowski P Mannion A
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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.

Methods

The data from 3′334 consecutive patients (1′789 women, 1′545 men; aged 61±15 years) undergoing first-time surgery between 1.1.2005 and 31.12.2010 for differing lumbar degenerative disorders were evaluated. The Core Outcome Measures Index (COMI) was completed by 3′124 (94%) patients preoperatively, 3′164 (95%) at 3 months follow-up, 3′153 (95%) at 1 year, 3′112 (93%) at 2 years, and 2′897 (87%) at 5 years. 2′502 (75%) completed COMI at all five timepoints.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 21 - 21
1 Feb 2014
Mannion A Kleinstück F Jeszenszky D Porchet F Haschtmann D Fekete T
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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).

Methods

12 mo after first-time surgery for LDH, patients completed 0–10 scales for back pain and leg pain and a question: “if you had to spend the rest of your life with the symptoms you have now, how would feel about it?,” answered on a 5-point Likert scale from “very satisfied” to “very dissatisfied”. This was dichotomised and used as the external criterion in receiver operating characteristics (ROC) analysis to derive the cut-off score for pain that best indicated being at least “somewhat satisfied” with the symptom state.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 25 - 25
1 Apr 2013
Mannion AF Fekete TF Mutter U Porchet F Kleinstück F Jeszenszky D
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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.

Methods

3′699 patients with degenerative lumbar disorders, undergoing surgery with the goal of pain relief, completed the multidimensional Core Outcome Measures Index (COMI; scored 0–10) before and 12 months after surgery. At 12mo they also rated the global treatment outcome and their satisfaction. Using the Eurospine Spine Tango Registry, surgeons documented surgical details, American Society of Anesthesiologists (ASA) scores and surgical/general complications.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 14 - 14
1 Jan 2013
Mannion A Fekete F Kleinstueck F Mutter U Lattig F Porchet F Jeszenszky D Grob D
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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.

Methods

Patients with lumbar degenerative disorders operated with the goal of pain relief, completed a questionnaire 1 year post-operatively enquiring about complications arising as a consequence of their operation. They rated the bothersomeness of any such complications on a 5-point adjectival scale. Global outcome of surgery and satisfaction were rated on 5-point Likert scales.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 440 - 440
1 Sep 2009
Grob D Mannion A Bartanusz V Kleinstück F Lattig F Jeszenszky D Dvorak J Porchet F
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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.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 411 - 411
1 Sep 2005
McCombe P Brotchi J Gill S Kahler R Lubansu A Nelson R Porchet F
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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.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 461 - 461
1 Apr 2004
McCombe P Brotchi J Gill S Kahler R Lubansu A Nelson R Porchet F
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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%.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 85 - 86
1 Jan 2004
Brotchi J Gill S Kahler R Lubansu A Nelson R McCombe P Porchet F
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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.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 281 - 281
1 Mar 2003
Brotchi J Gill S Kahler R Lubansu A Nelson R McCombe P Porchet F
Full Access

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.