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Single and multiple level lumbar disc arthroplasty for degenerative lumbar disc disease: outcome data at 24 months
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BASS 2017 abstracts / The Spine Journal 17 (2017) S3–S22
15. Single and multiple level lumbar disc arthroplasty for degenerative lumbar disc disease: outcome data at 24 months Nader Rehmatullah, Clare Morgan, Poonanand Goru, Ian Shackleford; Warrington General Hospital, Lovely Lane, Warrington, Cheshire BACKGROUND CONTEXT: Low back pain is one of the most prevalent spinal problems in the Western World with up to 80% of adults affected at some point during their lives. Degenerative disc disease is a significant contributor and the number of patients suffering from this condition will only rise as the population ages. Lumbar body fusion is an established procedure but suffers from a high rate of complications and adjacent level disease. Lumbar disc replacement (LDR) has the aim of preserving motion and avoiding fusion-related complications. PURPOSE: To determine the effectiveness of single level lumbar disc replacements and how multilevel replacements compared to single level. STUDY DESIGN/SETTING: Prospective Case Series, Local Hospital. PATIENT SAMPLE: All patients who underwent lumbar disc replacement over a 10 year period. OUTCOME MEASURES: ODI, VAS, CESD, LBOS. METHODS: We present our prospectively collected outcome data for single and multiple level arthroplasty using the Activ-L disc replacement. All patients who underwent lumbar disc replacement over a 10 year period were included. All patients had completed a minimum of 24 months follow-up. Clinical outcome measures include the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), Low Back Outcome Score (LBOS) and the Centre for Epidaemiologic Studies Depression Scale (CES-D). RESULTS: 177 patients with 97 single level (SL) and 80 multiple levels (ML) were included. Outcome scores significantly improved in both SL and ML cohorts to a similar degree. CES-D outcome scores improved to a greater degree in the ML cohort. This is the largest study to date comparing the results of SL against ML lumbar disc arthroplasty with 2 years follow-up. CONCLUSIONS: Our results suggest that single level and multi-level LDR is an effective operation for the treatment of degenerative disc disease with significant improvement in all outcome scores within 6 months and further improvement over 24 months. KEYWORDS: arthroplasty, Activ-L, ODI, VAS, LBOS, CES-D. CONFLICTS OF INTEREST: None. FUNDING SOURCES: None. http://dx.doi.org/10.1016/j.spinee.2016.12.023
16. The BACK to health programme: preliminary findings from a Combined Physical and Psychological Programme (CPPP) Paul Green, Cormac Ryan, Charles Greenough, Andrew Coxon, Glynis Peat, Helena Roper, Diarmaid Ferguson, Shaun Wellburn, Francis Fatoye, Sharon Hamilton, Denis Martin; South Tees Hospitals NHS Foundation Trust, Middlesbrough, England BACKGROUND CONTEXT: The BACK To Health programme is a component of the North of England Back Pain Pathway. It is a Combined Physical and Psychological Program (CPPP) based upon the NICE guidelines. PURPOSE: To present preliminary results of The BACK To Health programme. STUDY DESIGN/SETTING: An evaluation of the CPPP. This trial is registered on the ISRCTN registry [ISRCTN65093728] and received ethical approval from Teesside University. PATIENT SAMPLE: Adults with low back pain who have not responded to previous treatments. OUTCOME MEASURES: Pain (0–10 Numerical Rating Scale); function (Oswestry Disability Index [ODI]); quality-of-life (EQ-5D); anxiety (General Anxiety Disorder [GAD7]); depression (Patient Health Questionnaire [PHQ9]); Coping (0–10 Numerical Rating Scale) global outcome (Global Outcome Scale [GOS]); patient satisfaction (Friends and Family Test [FFT]). METHODS: The CPPP is a 3-week multidisciplinary residential programme, which provides a package of education, exercise, practical coping
strategies and group discussion. Patients completed outcome measures at baseline and discharge. RESULTS: Sixty-five patients (38 males, 27 females, mean age 44±12 years) were referred, 49 attended, and 47 completed. Significant improvements (mean difference [95%CI]) were seen for all outcome measures: pain (−1.4 [−1.9 to −0.9]); ODI (−7.5 [−10 to −5]); EQ5D (0.21 [0.15 to 0.27]); GAD7 (−4.9 [−6.5 to −3.4]); PHQ9 (−6.2 [−8.1 to −4.2]; coping (2.3 [1.6 to 2.9]). Seventyfour percent reported feeling a lot/moderately better, while 83% were extremely likely to recommend the service to friends and family. CONCLUSIONS: These preliminary findings highlight significant improvements in outcomes associated with the Back to Health Programme. These patients will be followed up at 6 and 12 months to evaluate medium to longterm outcomes. CONFLICTS OF INTEREST: None. FUNDING SOURCES: The Health Foundation; Academic Health Science Network (AHSN). http://dx.doi.org/10.1016/j.spinee.2016.12.024
17. Early readmission, delayed discharge, and reoperation after lumbar discectomy discectomy: an analysis from a multicenter, prospective, randomized study Gerrit Joan Bouma, P. Douglas Klassen, Claudius Thomé, Anular Closure R.C.T. Study Group, Frederic Martens; Neurosurgery, AMC—OLVG, P.O. Box 22600, 1100 DD Amsterdam BACKGROUND CONTEXT: Readmissions and reoperations within the first few months of surgery are major factors driving negative clinical and financial outcomes. Providers are increasingly being asked to bear the financial burden of hospital admissions that occur within 90 days of index surgery. Same-level reherniation and progressive degeneration are the main causes of poor outcome after lumbar discectomy and often require early readmission and reoperation. PURPOSE: This report evaluates the rates and costs of delayed discharge and readmission after primary lumbar discectomy within the first 30, 60 and 90 days after surgery in patients treated with a bone-anchored ACD (treatment group) compared with discectomy alone (control group). STUDY DESIGN/SETTING: Level 1, Superiority, RCT at 21 clinical sites in The Netherlands, France, Germany, Austria, Switzerland, and Belgium. PATIENT SAMPLE: The study population for this analysis consists of all enrolled patients (554 total: 278 control, 276 treatment) in the RCT. Key inclusion criteria include 6 weeks of failed conservative treatment, posterior disc height of ≥5 mm, minimum defect width and height, and baseline Oswestry and visual analog scale leg pain scores ≥40/100. OUTCOME MEASURES: # of surgical interventions post discectomy (Control) vs. discectomy and anular closure (Treatment) at 30, 60, and 90 days post-op. METHODS: Data from all patients enrolled were in the RCT were reviewed for post-operative readmission and reoperation. This report, which comports with the study statistical analysis plan, presents safety and early readmission and reoperation rates within the first 30, 60 and 90 days after surgery. RESULTS: Implanted patients in the treatment group had substantially lower incidences of readmissions or delayed discharges and index-level reoperations, compared with the control group. Reasons for reoperations within the first 90 days of surgery were similar for both groups and included surgeries for reherniation, bleeding, and wound revision.0–30 days post-op reoperation rate: Control: 2.9% vs. Treatment: 1.1%; 31–60 days post-op: Control: 4.7% vs. Treatment: 1.9%; 61–90 days post-op: Control: 4.7% vs. Treatment: 1.9%. CONCLUSIONS: Discectomy augmented with bone-anchored anular closure was associated with substantially lower rates of reoperations, early readmissions or delayed discharges, and associated costs compared to discectomy alone. These results suggest that bone-anchored anular closure could play an important role in reducing short-term clinical and financial burdens following lumbar discectomy. CONFLICTS OF INTEREST: The following authors have received consulting fees for medical education: Bouma, Klassen, Thomé, and
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.
BASS 2017 abstracts / The Spine Journal 17 (2017) S3–S22
15. Single and multiple level lumbar disc arthroplasty for degenerative lumbar disc disease: outcome data at 24 months Nader Rehmatullah, Clare Morgan, Poonanand Goru, Ian Shackleford; Warrington General Hospital, Lovely Lane, Warrington, Cheshire BACKGROUND CONTEXT: Low back pain is one of the most prevalent spinal problems in the Western World with up to 80% of adults affected at some point during their lives. Degenerative disc disease is a significant contributor and the number of patients suffering from this condition will only rise as the population ages. Lumbar body fusion is an established procedure but suffers from a high rate of complications and adjacent level disease. Lumbar disc replacement (LDR) has the aim of preserving motion and avoiding fusion-related complications. PURPOSE: To determine the effectiveness of single level lumbar disc replacements and how multilevel replacements compared to single level. STUDY DESIGN/SETTING: Prospective Case Series, Local Hospital. PATIENT SAMPLE: All patients who underwent lumbar disc replacement over a 10 year period. OUTCOME MEASURES: ODI, VAS, CESD, LBOS. METHODS: We present our prospectively collected outcome data for single and multiple level arthroplasty using the Activ-L disc replacement. All patients who underwent lumbar disc replacement over a 10 year period were included. All patients had completed a minimum of 24 months follow-up. Clinical outcome measures include the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), Low Back Outcome Score (LBOS) and the Centre for Epidaemiologic Studies Depression Scale (CES-D). RESULTS: 177 patients with 97 single level (SL) and 80 multiple levels (ML) were included. Outcome scores significantly improved in both SL and ML cohorts to a similar degree. CES-D outcome scores improved to a greater degree in the ML cohort. This is the largest study to date comparing the results of SL against ML lumbar disc arthroplasty with 2 years follow-up. CONCLUSIONS: Our results suggest that single level and multi-level LDR is an effective operation for the treatment of degenerative disc disease with significant improvement in all outcome scores within 6 months and further improvement over 24 months. KEYWORDS: arthroplasty, Activ-L, ODI, VAS, LBOS, CES-D. CONFLICTS OF INTEREST: None. FUNDING SOURCES: None. http://dx.doi.org/10.1016/j.spinee.2016.12.023
16. The BACK to health programme: preliminary findings from a Combined Physical and Psychological Programme (CPPP) Paul Green, Cormac Ryan, Charles Greenough, Andrew Coxon, Glynis Peat, Helena Roper, Diarmaid Ferguson, Shaun Wellburn, Francis Fatoye, Sharon Hamilton, Denis Martin; South Tees Hospitals NHS Foundation Trust, Middlesbrough, England BACKGROUND CONTEXT: The BACK To Health programme is a component of the North of England Back Pain Pathway. It is a Combined Physical and Psychological Program (CPPP) based upon the NICE guidelines. PURPOSE: To present preliminary results of The BACK To Health programme. STUDY DESIGN/SETTING: An evaluation of the CPPP. This trial is registered on the ISRCTN registry [ISRCTN65093728] and received ethical approval from Teesside University. PATIENT SAMPLE: Adults with low back pain who have not responded to previous treatments. OUTCOME MEASURES: Pain (0–10 Numerical Rating Scale); function (Oswestry Disability Index [ODI]); quality-of-life (EQ-5D); anxiety (General Anxiety Disorder [GAD7]); depression (Patient Health Questionnaire [PHQ9]); Coping (0–10 Numerical Rating Scale) global outcome (Global Outcome Scale [GOS]); patient satisfaction (Friends and Family Test [FFT]). METHODS: The CPPP is a 3-week multidisciplinary residential programme, which provides a package of education, exercise, practical coping
strategies and group discussion. Patients completed outcome measures at baseline and discharge. RESULTS: Sixty-five patients (38 males, 27 females, mean age 44±12 years) were referred, 49 attended, and 47 completed. Significant improvements (mean difference [95%CI]) were seen for all outcome measures: pain (−1.4 [−1.9 to −0.9]); ODI (−7.5 [−10 to −5]); EQ5D (0.21 [0.15 to 0.27]); GAD7 (−4.9 [−6.5 to −3.4]); PHQ9 (−6.2 [−8.1 to −4.2]; coping (2.3 [1.6 to 2.9]). Seventyfour percent reported feeling a lot/moderately better, while 83% were extremely likely to recommend the service to friends and family. CONCLUSIONS: These preliminary findings highlight significant improvements in outcomes associated with the Back to Health Programme. These patients will be followed up at 6 and 12 months to evaluate medium to longterm outcomes. CONFLICTS OF INTEREST: None. FUNDING SOURCES: The Health Foundation; Academic Health Science Network (AHSN). http://dx.doi.org/10.1016/j.spinee.2016.12.024
17. Early readmission, delayed discharge, and reoperation after lumbar discectomy discectomy: an analysis from a multicenter, prospective, randomized study Gerrit Joan Bouma, P. Douglas Klassen, Claudius Thomé, Anular Closure R.C.T. Study Group, Frederic Martens; Neurosurgery, AMC—OLVG, P.O. Box 22600, 1100 DD Amsterdam BACKGROUND CONTEXT: Readmissions and reoperations within the first few months of surgery are major factors driving negative clinical and financial outcomes. Providers are increasingly being asked to bear the financial burden of hospital admissions that occur within 90 days of index surgery. Same-level reherniation and progressive degeneration are the main causes of poor outcome after lumbar discectomy and often require early readmission and reoperation. PURPOSE: This report evaluates the rates and costs of delayed discharge and readmission after primary lumbar discectomy within the first 30, 60 and 90 days after surgery in patients treated with a bone-anchored ACD (treatment group) compared with discectomy alone (control group). STUDY DESIGN/SETTING: Level 1, Superiority, RCT at 21 clinical sites in The Netherlands, France, Germany, Austria, Switzerland, and Belgium. PATIENT SAMPLE: The study population for this analysis consists of all enrolled patients (554 total: 278 control, 276 treatment) in the RCT. Key inclusion criteria include 6 weeks of failed conservative treatment, posterior disc height of ≥5 mm, minimum defect width and height, and baseline Oswestry and visual analog scale leg pain scores ≥40/100. OUTCOME MEASURES: # of surgical interventions post discectomy (Control) vs. discectomy and anular closure (Treatment) at 30, 60, and 90 days post-op. METHODS: Data from all patients enrolled were in the RCT were reviewed for post-operative readmission and reoperation. This report, which comports with the study statistical analysis plan, presents safety and early readmission and reoperation rates within the first 30, 60 and 90 days after surgery. RESULTS: Implanted patients in the treatment group had substantially lower incidences of readmissions or delayed discharges and index-level reoperations, compared with the control group. Reasons for reoperations within the first 90 days of surgery were similar for both groups and included surgeries for reherniation, bleeding, and wound revision.0–30 days post-op reoperation rate: Control: 2.9% vs. Treatment: 1.1%; 31–60 days post-op: Control: 4.7% vs. Treatment: 1.9%; 61–90 days post-op: Control: 4.7% vs. Treatment: 1.9%. CONCLUSIONS: Discectomy augmented with bone-anchored anular closure was associated with substantially lower rates of reoperations, early readmissions or delayed discharges, and associated costs compared to discectomy alone. These results suggest that bone-anchored anular closure could play an important role in reducing short-term clinical and financial burdens following lumbar discectomy. CONFLICTS OF INTEREST: The following authors have received consulting fees for medical education: Bouma, Klassen, Thomé, and
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.