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Study Design.This was a dual-center study over an eight-year period on patients undergoing single level fusion surgery with either posterior- (PLIF) or transforaminal lumbar interbody fusion (TLIF). We analyzed prospectively collected pre- and postoperative data from the national Danish surgical spine database (DaneSpine).Objective.The aim of this study was to compare clinical and patient-reported outcome (PRO) 2 years after TLIF or PLIF in patients with symptomatic lumbar mechanical disc degeneration.Summary of Background Data.PLIF and TLIF are well-described techniques for treating lumbar mechanical disc degeneration but whether the theoretical differences between the two techniques translate to different clinical outcomes is unknown.Methods.The primary outcome was Oswestry Disability Index (ODI) score at 2-year follow-up. Secondary outcome measures were scores on the European Quality of Life-5 Dimensions (EQ-5D) and visual analog scale (VAS) and the rate of intraoperative complications. To minimize baseline differences between the groups, propensity-score matching was employed in a 1:1 fashion, balancing the groups on preoperative factors including age, sex, back and leg pain, ODI, EQ-5D, and previous spine surgery.Result.The matched cohort included 211 patients in each cohort. There was no significant difference between the groups in the mean score on the ODI at two years (PLIF: 33 ± 20 vs. TLIF: 35 ± 20, P = 0.328). We found no statistically significant differences in EQ-5D score (0.54 ± 0.35 vs. 0.51 ± 0.34, P = 0.327), VAS score for back pain (47 ± 32 vs. 48 ± 29, P = 0.570) or leg pain (42 ± 33 vs. 41 ± 32, P = 0.936) between the PLIF and TLIF groups, respectively, at 2-year follow-up. Dural tears occurred in 9.5% in the PLIF group and 1.9% in the TLIF group (P = 0.002) corresponding to a relative risk of 5.0 (95% CI 1.7-14.4).Conclusion.We found no significant difference in PRO at 2-year follow-up between PLIF and TLIF for the treatment of lumbar disc degeneration. PLIF is associated with a five times higher risk of dural tears.Level of Evidence: 3.

STUDY DESIGN: A registry-based comparative cohort study with 2-year follow-up.OBJECTIVE: To assess whether Modic changes (MCs) are associated with health-related quality of life, long-term physical disability, back- or leg pain after discectomy.SUMMARY OF BACKGROUND DATA: Previous studies have failed to show a clinically significant association between MCs and patient-reported outcomes (PROs) after discectomy.METHODS: Data from the Danish National Spine Registry on patients undergoing first-time lumbar discectomy at a single institution from 2014 to 2017 with an accessible preoperative lumbar magnetic resonance imaging, complete preoperative, and 2-year follow-up questionnaires were obtained. PROs including Oswestry disability index (ODI), European Quality of Life-Five Dimensions (EQ-5D), visual analogue scale (VAS) back and leg pain, and patient satisfaction were collected. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the preoperative MRI.RESULTS: Of 620 patients included, MCs were present in 290 patients (47%). Of these, MC type 1 (MC-1) was present in 73 (25%) and MC type 2 (MC-2) in 217 (75%) patients. Preoperative data for ODI, EQ-5D, VAS-BP, and VAS-LP were comparable for the +MC and -MC groups. Both groups had a statistically significant improvement in PROs from baseline compared with 2-year follow-up (P CONCLUSION: MCs were not found to be associated with health-related quality of life, disability, back- or leg pain, or patient satisfaction 2 years after discectomy.LEVEL OF EVIDENCE: 2.

Study Design Randomized controlled trial with minimum of 5-years follow-up. Objective The purpose of this study is to evaluate the peri- and postoperative complications rates, ectopic bone migration, and reoperation rates, and secondly evaluate the 5-year patient reported outcomes (PROs), in patients treated with decompression and non-instrumented posterolateral fusion with ABM/P-15 or allograft. Methods Patients with degenerative spondylolisthesis were enrolled in a Randomized Clinical Trial and randomized 1:1 to either ABM/P-15 or allograft bone. Patient Reported Outcomes were collected at 5-year follow-up, and patients were invited to a clinical follow-up including a computed tomography scan (CT) to evaluate signs of osteolysis, ectopic bone formation, and bone migration. Results Of 101 subjects enrolled in the primary study, 83 patients were available for the 5-year follow-up. We found a statistically significant difference in back pain and Oswestry Disability Index between groups. Fifty-eight patients agreed to participate in the CT study. Sixty percentage in the ABM/P-15 group vs 30% in the allograft group was classified as fused ( P = .037). There were no differences in complications, reoperation-, or infection rates between the 2 groups. We found 2 patients with migration of graft material. Both patients were asymptomatic at minimum 5-year follow-up. Conclusion Our study indicated that complication rates are no higher in patients treated with ABM/P-15 than allograft. We found significantly higher fusion rates in the AMB/P-15 group than in the allograft group, and patients in the ABM/P-15 group reported less back pain and lower disability score at 5-year follow-up.

Study Design: Retrospective cohort study. Objectives: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. Methods: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). Results: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. Conclusion: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.

BACKGROUND CONTEXT There continues to be a search for an ideal bone graft substitute that leads to improved fusion rates compared to autograft that has little to no known adverse effects. One of the latest bone graft substitutes is ABM/P-15. The RCT showed that there was a fusion rate of 50% in the ABM/P-15 group and 20% in the Allograft group. PURPOSE The purpose of this study is to report on the complications and reoperations in patients enrolled in a randomized controlled trial comparing ABM/P-15 to Allograft in un-instrumented fusion due to lumbar degenerative spondylolisthesis. STUDY DESIGN/SETTING Randomized controlled trial with 6 years follow-up. PATIENT SAMPLE Of 101 patients enrolled in a randomized controlled trial comparing ABM/P-15 to Allograft, 59 patients were available at 6 years postoperative, 30 in the ABM/P-15 group and 29 in the Allograft groups. OUTCOME MEASURES Any complication reported by the patient or identified during the patient's postoperative visit, including changes seen on radiographic imaging; and reoperations. METHODS Randomized controlled trial comparing ABM/P-15 vs allograft with a minimum of 6 years follow-up. RESULTS Of the 101 patients who were included in the RCT, 9 patients had wound complications during admission, 3 in the AMB/P15 group and 6 in the allograft group (p=0.254). One patient in each group had a superficial wound infection which required antibiotic treatment. Twenty-one patients had a reoperation during the 6 years follow-up, 12 in the Allograft group and 9 in the ABM/P15 group (p=0.331). Of the 59 patients available for 6-year follow-up, no osteolysis in the vertebrae was seen in any CT scan at 6 years after surgery. One patient in the ABM/P15 had a calcified hematoma, and one patient had bone migrating ventral from the transverse process into the psoas muscle. Both patients were asymptomatic. CONCLUSIONS Complication and reoperation rates were similar in patients treated with ABM/P15 compared to allograft. FDA DEVICE/DRUG STATUS ABM/P-15 (Not approved for this indication)

BACKGROUND CONTEXT Lumbar spinal stenosis (LSS) is a common condition in the elderly population and is associated with significant morbidity and decreased quality of life. Many patients manage with little to no treatment, but for the patients in whom lower extremity pain and disability are unacceptable, surgical intervention is shown to provide good relief of symptoms and pain. There is little evidence on how many patients obtain a clinically relevant improvement in function and whether this effect is sustained 5 years after surgery. PURPOSE The aim of this study was to evaluate the proportion of patients who achieve and maintain a clinically relevant improvement at 1, 2 and 5 years postoperatively. STUDY DESIGN/SETTING The study was performed as a retrospective cohort study on patients who underwent surgery at the Spine Centre of Southern Denmark, Middelfart; The Regional Hospital of Silkeborg and University Hospital of Zealand in Koge. PATIENT SAMPLE A total of 6,063 patients who underwent decompression due to spinal stenosis at three spine centers in Denmark were included in our study. We had follow-up data available on our main outcome measure (ODI) on 75% at 1-year, 70% at 2-year, and 62% at 5-year follow-up. OUTCOME MEASURES Oswestry Disability Index (ODI), EuroQoL-5D-3L (EQ-5D), visual analogue scale leg pain (VAS-leg) and visual analogue scale back pain (VAS-back). METHODS We included patients who underwent first-time decompression due to LSS at three tertiary Spine Centers in Denmark. Data was collected prospectively in the National Spine Registry of Denmark (DaneSpine). Based on the outcome measures, the patients who obtained a minimal clinically relevant difference in outcome (MCID) were identified at 1-, 2- and 5-years post-surgery. RESULTS The mean change from baseline to 5-years post-surgery was 0.2 on EQ-5D; -18.9 on ODI, -18.9 on VAS back and 29.8 on VAS. We found that 86% of patients obtained the MCID on at least one parameter, with 68.9% obtaining MCID on two or more outcome measures. VAS back was found with a statistically important difference in the percentage of patients who achieved MCID at 1- and 5-years postsurgery. For the remaining outcome measures no statistically important difference was found. CONCLUSIONS Decompression as treatment for LSS is a safe and reliable option with low complication rates. Most patients achieve a clinically relevant difference in outcome on one or more parameters, which is maintained 5 years after surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Degenerative spondylolisthesis (DS) is a common condition in the elderly population which is associated with significant morbidity and decreased quality of life. For patients where pain and disability are unacceptable, surgical intervention with lumbar decompression is a commonly used treatment option, shown to provide relief of symptoms and pain. Few studies have examined if a clinically relevant difference in function is obtained, and whether this effect is sustained at long term. PURPOSE The aim of this study was to evaluate patient reported outcomes and whether patients obtain a clinically relevant improvement after surgery, and if the effect of treatment is sustained at 1, 2 and 5 years postoperatively. STUDY DESIGN/SETTING The study was performed as a retrospective cohort study on patients who underwent surgery at the Spine Centre of Southern Denmark, Middelfart, the Regional Hospital of Silkeborg and University Hospital of Zealand in Koge. PATIENT SAMPLE A total of 1,241 patients had surgery for LSS with DS during the inclusion period. All patients underwent decompression and non-instrumented fusion. We had follow-up data available on our main outcome measure (ODI) on 79.8% at 1 year, 74.8% at 2 year, and 74.2% at 5-year follow-up. OUTCOME MEASURES Oswestry Disability Index (ODI), EuroQoL-5D-3L (EQ-5D), Visual Analogue Scale Leg Pain (VAS-leg) and Visual Analogue Scale Back Pain (VAS-back). METHODS The study was performed as a multicentre registry-based retrospective cohort study using data collected prospectively in the Danish national surgical spine database; DaneSpine. In DaneSpine, patient reported outcomes are collected preoperatively, and 1, 2,5 and 10 years postoperative. This study evaluates both preoperative and postoperative outcomes. Data was collected via patient reported questionnaires, all PRO measures were filled out preoperatively and at 1, 2 and 5 years postoperatively. Based on the outcome measures, the patients who obtained a minimal clinically relevant difference in outcome (MCID) were identified at 1, 2 and 5 years postsurgery. RESULTS We found a mean change from 1 to 5 years of -20.9 on ODI; a mean change of 0.22 on EQ.5D, 30.5 on VAS leg and 20.6 on VAS back. We found that 90% of patients obtained a clinically relevant increase in one or more PROs. Apart from VAS back, there was no statistical difference in percentage of patients who obtained MCID at 1, 2 and 5-years postsurgery. CONCLUSIONS Surgery for LSS with DS has favorable results, with most patients experiencing a clinically important change in outcome measures that is maintained for at least 5 years. Of the patients who undergo surgery for LSS with DS, 90% can expect a meaningful change in outcome measures on at least one parameter. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT: Lumbar disc herniation (LDH) is associated with great morbidity and significant socioeconomic impact in many parts of the world. Studies have shown that most LDH can be treated effectively with nonoperative management. However, for some patients in whom pain and disability are unacceptable, surgical intervention provides effective clinical relief. Currently there is little consensus in the medical community on the timing of surgery for patients suffering from radicular pain due to LDH. Multiple studies suggest that prolonged symptom duration adversely affects clinical outcome.PURPOSE: The aim of this study is to evaluate if prolonged symptom duration is correlated with less favorable outcome following surgery for LDH.STUDY DESIGN/SETTING: Consecutive series of patients from a single-center, multi-surgeon, tertiary spine practice.PATIENT SAMPLE: Consecutive series of patients who underwent surgery for lumbar disc herniation.OUTCOME MEASURES: Oswestry Disability Index (ODI), EuroQol-5D (EQ-5D) and Visual Analog Scale (VAS) for back and leg pain (0 to 100).METHODS: Patients with a first episode LDH were included. Data were prospectively collected in DaneSpine, the Danish National Spine Registry. Subjects were divided into three groups based on their preoperative self-reported duration of leg pain: 12-months. Associations between patient-reported outcomes (PROs), perioperative complications and duration of symptoms were evaluated. Statistical significance level was set at p-value RESULTS: There were 2,144 patients included in the study, with complete one-year follow-up on 1,694 patients (79%) and a reoperation rate of 8.4%. Incidence of surgical complications, specifically dural tears, was higher with increasing duration of leg pain, however, this did not reach statistical significance (p=0.039). Prolonged preoperative symptoms adversely influenced all PROs (EQ-5D, ODI, VAS) one year after surgery (p=0.001). Furthermore, reoperation rates increased with longer duration of preoperative symptoms. A statistically significant trend (p=0.008) of increasing incidence of reoperation was found with increasing length of symptom duration.CONCLUSIONS: Delayed surgical intervention results in inferior outcomes and increased reoperation rates. Patients who had surgery within the first 3 months of leg pain achieved significantly better outcome one year after surgery when compared to the other groups.

BACKGROUND CONTEXT: Due to poor bone stock in the elderly, a noninstrumented fusion is commonly performed in Scandinavia when instability is present. Allograft bone is often used as graft extender with consequent low fusion rates. The use of 15 amino acid residue (ABM/P-15) has shown superior fusion rates in dental and cervical spinal surgery but no clinical studies have been conducted in noninstrumented lumbar fusion surgery.PURPOSE: To evaluate patient reported outcomes (PROs) and the intertransverse fusion rate in noninstrumented posterolateral fusion with either ABM/P-15 or allograft.STUDY DESIGN: Double-blind randomized clinical trial.PATIENT SAMPLE: Patients 60 years or older with degenerative spondylolisthesis undergoing decompression and noninstrumented posterolateral fusion.OUTCOME MEASURES: Visual analog scales for back and leg pain, Oswestry Disability Index and EuroQoL-5D.METHODS: One hundred one patients were enrolled in the study and randomized 1:1 to either ABM/P-15 (mixed 50/50, 5cc/level) or allograft bone (30 g/level), both mixed with local bone graft. PROs were collected at baseline and at 12 and 24 months after surgery. The patients underwent 1-year postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions, independently evaluated by three reviewers. Fusion status was concluded by consensus of two of the three as "fusion" or "no fusion."RESULTS: There were 49 patients available for analysis in both cohorts. The two groups were similar in terms of sex distribution, age, and number of levels fused. The fusion rate was significantly higher in the ABM/P-15 group with 50% fused compared with 20% in the allograft group. PROs at baseline and at all follow-up time points were similar between the two groups.CONCLUSIONS: Patients undergoing noninstrumented posterolateral fusion augmented with ABM/P-15 had a statistically significantly higher fusion rate compared with allograft when evaluated with postoperative fine cut computed tomography-scans (0.9 mm) with reconstructions. However, this did not translate to better clinical outcomes.

The Danish Health Authority has recently published a new guideline on the treatment of lumbar disc herniation with radiculopathy. This paper goes through the surgical treatment and considers the evidence behind surgical treatment of these patients, along with the outcome reported in literature. The new guideline recommends referring patients to be assessed by a surgeon within 12 weeks in cases, where severe and debilitating pain persists despite non-surgical treatment. This is found to be well in line with literature, as many studies have shown time to be a predictive factor in surgical treatment of these patients.

The objective of this paper is to give insight into evidence-based recommendations on key clinical questions regarding treatment of lumbar disc herniation with radiculopathy. This paper is based on the recently published Danish national clinical guideline for non-operative treatment. Limited evidence is found regarding non-surgical treatment of patients with lumbar radiculopathy. Physiotherapy, in the form of group sessions, seems to have the best level of evidence. However, evidence is still very limited and of poor quality. No evidence has been found with regards to acupuncture or manipulation therapy.