Surgery in Degenerative Spondylolisthesis: Does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial)

BACKGROUND CONTEXT Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. PURPOSE To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. DESIGN A secondary exploratory study using data from the Norwegian Degenerative Spondylolisthesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. PATIENT SAMPLE The sample in this study consists of 267 patients from a randomized multicenter trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe foraminal stenosis, multilevel spondylolisthesis, or previous surgery. OUTCOME MEASURES The primary outcome was an improvement of ≥ 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. METHODS When investigating possible variables that could modify the treatment effect, we analyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. RESULTS Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16–16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02–1.50]) were significantly associated with an improved primary outcome. CONCLUSIONS In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treatment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery.publishedVersio

Long-term clinical and radiological results in patients with chronic low back pain and degenerative disc randomised to total disc replacement or multidisciplinary rehabilitation

Lumbar total disc replacement is a treatment option for selected patients with chronic low back pain and intervertebral disc degeneration. The treatment was introduced as a motion-preserving alternative to spinal fusion, which has been reported to increase the risk of adjacent disc degeneration. The thesis is based on an 8-year follow-up of a multicentre randomised controlled trial performed at five university hospitals in Norway. The sample consists of 173 patients aged 25-55 years with chronic low back pain and localized degenerative changes in the lumbar intervertebral discs. We found a substantial long-term improvement both after total disc replacement and multidisciplinary rehabilitation. The difference between the groups was statistically significant in favour of surgery, but smaller than the pre-specified clinical important difference that the study was designed to detect. Patients with Modic changes prior to the disc replacement were more likely to report a clinically important functional improvement. Increased adjacent disc degeneration occurred with similar frequency after disc replacement and non-operative treatment and was not related to the long-term clinical outcome

Facet arthropathy evaluation: CT or MRI?

Objective - To assess the reliability of lumbar facet arthropathy evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) in patients with and without lumbar disc prosthesis and to estimate the reliability for individual CT and MRI findings indicating facet arthropathy. Methods - Metal-artifact reducing CT and MRI protocols were performed at follow-up of 114 chronic back pain patients treated with (n = 66) or without (n = 48) lumbar disc prosthesis. Three experienced radiologists independently rated facet joint space narrowing, osteophyte/hypertrophy, erosions, subchondral cysts, and total grade facet arthropathy at each of the three lower lumbar levels on both CT and MRI, using Weishaupt et al’s rating system. CT and MRI examinations were randomly mixed and rated independently. Findings were dichotomized before analysis. Overall kappa and (due to low prevalence) prevalence- and bias-adjusted kappa were calculated to assess interobserver agreement. Results - Interobserver agreement on total grade facet arthropathy was moderate at all levels with CT (kappa 0.47–0.48) and poor to fair with MRI (kappa 0.20–0.32). Mean prevalence- and bias-adjusted kappa was lower for osteophyte/hypertrophy versus other individual findings (CT 0.58 versus 0.79–0.86, MRI 0.35 versus 0.81–0.90), higher with CT versus MRI when rating osteophyte/hypertrophy (0.58 versus 0.35) and total grade facet arthropathy (0.54 versus 0.31), and generally similar at levels with versus levels without disc prosthesis. Conclusion - Interobserver agreement on facet arthropathy was moderate with CT and better with CT than with MRI. Disc prosthesis did not influence agreement. A more reliable grading of facet arthropathy requires a more consistent evaluation of osteophytes/hypertrophy

Facet arthropathy evaluation: CT or MRI?

Objective To assess the reliability of lumbar facet arthropathy evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) in patients with and without lumbar disc prosthesis and to estimate the reliability for individual CT and MRI findings indicating facet arthropathy. Methods Metal-artifact reducing CT and MRI protocols were performed at follow-up of 114 chronic back pain patients treated with (n = 66) or without (n = 48) lumbar disc prosthesis. Three experienced radiologists independently rated facet joint space narrowing, osteophyte/hypertrophy, erosions, subchondral cysts, and total grade facet arthropathy at each of the three lower lumbar levels on both CT and MRI, using Weishaupt et al’s rating system. CT and MRI examinations were randomly mixed and rated independently. Findings were dichotomized before analysis. Overall kappa and (due to low prevalence) prevalence- and bias-adjusted kappa were calculated to assess interobserver agreement. Results Interobserver agreement on total grade facet arthropathy was moderate at all levels with CT (kappa 0.47–0.48) and poor to fair with MRI (kappa 0.20–0.32). Mean prevalence- and bias-adjusted kappa was lower for osteophyte/hypertrophy versus other individual findings (CT 0.58 versus 0.79–0.86, MRI 0.35 versus 0.81–0.90), higher with CT versus MRI when rating osteophyte/hypertrophy (0.58 versus 0.35) and total grade facet arthropathy (0.54 versus 0.31), and generally similar at levels with versus levels without disc prosthesis. Conclusion Interobserver agreement on facet arthropathy was moderate with CT and better with CT than with MRI. Disc prosthesis did not influence agreement. A more reliable grading of facet arthropathy requires a more consistent evaluation of osteophytes/hypertrophy

Non-operative versus operative treatment of suprasyndesmotic ankle fractures: protocol for a prospective, multicentre, randomised controlled trial

Introduction Surgery is widely recognised as the treatment of choice for suprasyndesmotic ankle fractures, because of the assumption that these injuries yield instability of the ankle joint. Stability assessment of ankle fractures using weightbearing radiographs is now used regularly to guide the treatment of transsyndesmotic and infrasyndesmotic ankle fractures. Patients with a congruent ankle joint on weightbearing radiographs can be treated non-operatively with excellent results. Weightbearing radiographs are, however, rarely performed on suprasyndesmotic fractures due to the assumed unstable nature of these fractures. If weightbearing radiographs can be used to identify suprasyndesmotic fractures suitable for non-operative treatment, we may save patients from the potential burdens of surgery.Our aim is to compare the efficacy of operative and non-operative treatment of patients with suprasyndesmotic ankle fractures that reduce on weightbearing radiographs.Methods and analysis A non-inferiority randomised controlled trial involving 120 patients will be conducted. A total of 120 patients with suprasyndesmotic ankle fractures with an initial radiographic medial clear space of <7 mm will be subjected to weightbearing radiographs. If the tibio-talar joint is completely reduced, we will randomise in a 1:1 ratio to either operative treatment including reduction and fixation of the syndesmosis or non-operative treatment with an orthosis. The primary study outcome is patient-reported ankle function and symptoms as measured by the Olerud-Molander Ankle Score at 2-year follow-up. Secondary outcomes include the Manchester-Oxford Foot Questionnaire, range of motion, radiographic results and rates of adverse events.Ethics and dissemination The Regional Committee for Medical and Health Research South East, group A (permission number: 169307), has granted ethics approval. The results of this study will provide valuable insights for developing future diagnostic and treatment strategies for a common fracture type. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.Trial registration number NCT04615650

Evaluation of the EQ-5D-3L and 5L versions in low back pain patients

Background The EuroQol EQ-5D is one of the most widely researched and applied patient-reported outcome measures worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). Methods LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). Results At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon’s indices showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. Conclusion The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended

Adjacent Disc Degeneration After Lumbar Total Disc Replacement or Non-operative Treatment: A Randomized Study With Eight-year Follow-up.

STUDY DESIGN: A randomized controlled multicenter trial with 8-year follow-up. OBJECTIVE: The aim of this study was to assess the long-term development of adjacent disc degeneration (ADD) after lumbar total disc replacement (TDR) or nonoperative treatment, and to analyze the association between ADD development and clinical outcome. SUMMARY OF BACKGROUND DATA: TDR was introduced as a motion-preserving alternative to spinal fusion, which has been reported to increase the risk of ADD. However, ADD may develop naturally regardless of any surgery, and no randomized study has assessed the long-term development of ADD after TDR versus nonoperative treatment. METHODS: The study included 126 of the 173 patients with chronic low back pain (LBP) originally included in a randomized study comparing TDR with multidisciplinary rehabilitation. Magnetic resonance imaging (MRI) of the lumbar spine was performed before treatment and at 8-year follow-up. ADD was categorized as increased or not increased based on an evaluation of Modic changes, disc height reduction, disc contour, herniation size, nucleus pulposus signal, and posterior high intensity zones. We used a χ test or a Fisher exact test to compare crude proportions, and multiple linear regressions to analyze the association between increased ADD (yes/no) and change in Oswestry Disability Index (ODI) from pre-treatment to follow-up. RESULTS: ADD increased (for at least one ADD variable) in 23 of 57 patients (40%) treated nonoperatively, and 29 of 69 patients (42%) treated with TDR (P = 0.86). We found no significant associations between ADD increase and the change in ODI. CONCLUSION: Increased ADD occurred with similar frequency after TDR and after nonoperative treatment, and was not related to the clinical outcome at 8-year follow-up. LEVEL OF EVIDENCE: 1

Evaluation of the EQ-5D-3L and 5L versions in low back pain patients

Background The EuroQol EQ-5D is one of the most widely researched and applied patient-reported outcome measures worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). Methods LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). Results At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon’s indices showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. Conclusion The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended

Adjacent Disc Degeneration After Lumbar Total Disc Replacement or Non-operative Treatment: A Randomized Study With Eight-year Follow-up

Study Design: A randomized controlled multicenter trial with 8-year follow-up. Objective: The aim of this study was to assess the long-term development of adjacent disc degeneration (ADD) after lumbar total disc replacement (TDR) or nonoperative treatment, and to analyze the association between ADD development and clinical outcome. Summary of Background Data: TDR was introduced as a motion-preserving alternative to spinal fusion, which has been reported to increase the risk of ADD. However, ADD may develop naturally regardless of any surgery, and no randomized study has assessed the long-term development of ADD after TDR versus nonoperative treatment. Methods: The study included 126 of the 173 patients with chronic low back pain (LBP) originally included in a randomized study comparing TDR with multidisciplinary rehabilitation. Magnetic resonance imaging (MRI) of the lumbar spine was performed before treatment and at 8-year follow-up. ADD was categorized as increased or not increased based on an evaluation of Modic changes, disc height reduction, disc contour, herniation size, nucleus pulposus signal, and posterior high intensity zones. We used a χ2 test or a Fisher exact test to compare crude proportions, and multiple linear regressions to analyze the association between increased ADD (yes/no) and change in Oswestry Disability Index (ODI) from pre-treatment to follow-up. Results: ADD increased (for at least one ADD variable) in 23 of 57 patients (40%) treated nonoperatively, and 29 of 69 patients (42%) treated with TDR (P = 0.86). We found no significant associations between ADD increase and the change in ODI. Conclusion: Increased ADD occurred with similar frequency after TDR and after nonoperative treatment, and was not related to the clinical outcome at 8-year follow-up. Level of Evidence:

Adjacent Disc Degeneration After Lumbar Total Disc Replacement or Non-operative Treatment: A Randomized Study With Eight-year Follow-up

Study Design. A randomized controlled multicenter trial with 8-year follow-up. Objective. The aim of this study was to assess the long-term development of adjacent disc degeneration (ADD) after lumbar total disc replacement (TDR) or nonoperative treatment, and to analyze the association between ADD development and clinical outcome. Summary of Background Data. TDR was introduced as a motion-preserving alternative to spinal fusion, which has been reported to increase the risk of ADD. However, ADD may develop naturally regardless of any surgery, and no randomized study has assessed the long-term development of ADD after TDR versus nonoperative treatment. Methods. The study included 126 of the 173 patients with chronic low back pain (LBP) originally included in a randomized study comparing TDR with multidisciplinary rehabilitation. Magnetic resonance imaging (MRI) of the lumbar spine was performed before treatment and at 8-year follow-up. ADD was categorized as increased or not increased based on an evaluation of Modic changes, disc height reduction, disc contour, herniation size, nucleus pulposus signal, and posterior high intensity zones. We used a χ2 test or a Fisher exact test to compare crude proportions, and multiple linear regressions to analyze the association between increased ADD (yes/no) and change in Oswestry Disability Index (ODI) from pre-treatment to follow-up. Results. ADD increased (for at least one ADD variable) in 23 of 57 patients (40%) treated nonoperatively, and 29 of 69 patients (42%) treated with TDR (P = 0.86). We found no significant associations between ADD increase and the change in ODI. Conclusion. Increased ADD occurred with similar frequency after TDR and after nonoperative treatment, and was not related to the clinical outcome at 8-year follow-up