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. KEY POINTS: • In this study, interobserver agreement on facet arthropathy (FA) severity-based on facet joint space narrowing, osteophyte/hypertrophy, erosions, and subchondral cysts-was better with CT versus MRI. • Metal-artifact reducing CT and MRI protocols helped to improve visibility and maintain agreement when evaluating severity of FA at levels with metallic disc prosthesis. • Agreement was poorer for severity of osteophytes/hypertrophy than for the other evaluated FA findings; improved agreement on total grade FA evaluated with CT or MRI thus requires more consistent grading of osteophytes/hypertrophy between different radiologists.

Lumbar total disc replacement: predictors for long-term outcome.

PURPOSE: We aimed to identify patient characteristics associated with favourable long-term outcomes after lumbar total disc replacement (TDR). METHODS: We analysed a cohort of 82 patients with degenerative disc and chronic low back pain (LBP) who were treated with TDR and originally participated in a randomised trial comparing TDR and multidisciplinary rehabilitation. Potential predictors were measured at baseline, and the outcomes assessed 8 years after they received allocated treatment. Outcome measures were dichotomised according to whether the participants achieved a clinically important functional improvement (15 points or more on the Oswestry Disability Index, ODI) (primary outcome) and whether they were employed at 8-year follow-up (secondary outcome). Associations between potential predictors and outcomes were modelled using logistic regression. For the secondary outcome, the results were also organised in a prediction matrix and expressed as probabilities. RESULTS: For 71 patients treated with TDR according to protocol, the follow-up time was 8 years. For a subgroup of 11 patients randomised to rehabilitation who crossed over and received TDR, the median postoperative follow-up time was 72 (range 41-88) months. Of all assessed baseline variables, only presence of Modic changes (type 1 and/or 2) was statistically significantly associated with an improvement of ≥ 15 ODI points. The probability of employment at 8-year follow-up was 1% for patients with ≥ 1 year of sick leave, comorbidity, ODI ≥ 50 and ≤ 9 years of education prior to treatment, and 87% for patients with < 1 year of sick leave, no comorbidity, ODI < 50 and higher education. CONCLUSIONS: Patients with Modic changes prior to the TDR surgery were more likely to report a clinically important functional improvement at long-term follow-up. Comorbidity, low level of education, long-term sick leave and high ODI score at baseline were associated with unemployment at long-term follow-up.

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.

Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial.

OBJECTIVE: To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis. DESIGN: Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS). SETTING: 16 public orthopaedic and neurosurgical clinics in Norway. PARTICIPANTS: Patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level. INTERVENTIONS: Decompression surgery alone and decompression with additional instrumented fusion (1:1). MAIN OUTCOME MEASURES: The primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a -15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire. RESULTS: From 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) -11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of -1.3 percentage points (95% CI -14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of -15%. The mean change in Oswestry disability index from baseline to five years was -17.8 in both groups (mean difference 0.02 (95% CI -3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively. CONCLUSIONS: In participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT02051374.

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. TRIAL REGISTRATION: NORDSTEN-DS ClinicalTrials.gov, NCT02051374.

Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis: A Randomized Clinical Trial.

Importance: Operations for lumbar spinal stenosis is the most often performed surgical procedure in the adult lumbar spine. This study reports the clinical outcome of the 3 most commonly used minimally invasive posterior decompression techniques. Objective: To compare the effectiveness of 3 minimally invasive posterior decompression techniques for lumbar spinal stenosis. Design, Setting, and Participants: This randomized clinical trial used a parallel group design and included patients with symptomatic and radiologically verified lumbar spinal stenosis without degenerative spondylolisthesis. Patients were enrolled between February 2014 and October 2018 at the orthopedic and neurosurgical departments of 16 Norwegian public hospitals. Statistical analysis was performed in the period from May to June 2021. Interventions: Patients were randomized to undergo 1 of the 3 minimally invasive posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy, and spinous process osteotomy. Main Outcomes and Measures: Primary outcome was change in disability measured with Oswestry Disability Index (ODI; range 0-100), presented as mean change from baseline to 2-year follow-up and proportions of patients classified as success (>30% reduction in ODI). Secondary outcomes were mean change in quality of life, disease-specific symptom severity measured with Zurich Claudication Questionnaire (ZCQ), back pain and leg pain on a 10-point numeric rating score (NRS), patient perceived benefit of the surgical procedure, duration of the surgical procedure, blood loss, perioperative complications, number of reoperations, and length of hospital stay. Results: In total, 437 patients were included with a median (IQR) age of 68 (62-73) years and 230 men (53%). Of the included patients, 146 were randomized to unilateral laminotomy with crossover, 142 to bilateral laminotomy, and 149 to spinous process osteotomy. The unilateral laminotomy with crossover group had a mean change of -17.9 ODI points (95% CI, -20.8 to -14.9), the bilateral laminotomy group had a mean change of -19.7 ODI points (95% CI, -22.7 to -16.8), and the spinous process osteotomy group had a mean change of -19.9 ODI points (95% CI, -22.8 to -17.0). There were no significant differences in primary or secondary outcomes among the 3 surgical procedures, except a longer duration of the surgical procedure in the bilateral laminotomy group. Conclusions and Relevance: No differences in clinical outcomes or complication rates were found among the 3 minimally invasive posterior decompression techniques used to treat patients with lumbar spinal stenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT02007083.

Facet Arthropathy Following Disc Replacement Versus Rehabilitation: A Prospective Study With 8-Year Follow-Up.

STUDY DESIGN: A prospective study of patients originally randomized to total disc replacement (TDR) or multidisciplinary rehabilitation. OBJECTIVE: To assess the long-term development of facet arthropathy (FA) after TDR versus nonoperative treatment, and to analyze the association between FA and clinical outcome. SUMMARY OF BACKGROUND DATA: FA may appear or increase following TDR, but the natural course of FA is unclear, and no previous study has evaluated the long-term development of FA following TDR compared with nonoperative treatment. METHODS: The study included 126 patients with chronic low back pain and degenerative changes in the lumbar intervertebral discs. The patients underwent pretreatment and 8-year follow-up magnetic resonance imaging (MRI) and 8-year follow-up computed tomography (CT) of the lumbar spine. The primary outcome measure was FA development (yes/no) on MRI at index level L4/L5 or L5/S1, defined as increased FA grade value from pretreatment to follow-up according to Weishaupt grading system. Secondary outcomes included the association between FA (on MRI and CT) and Oswestry Disability Index (ODI) or back pain as well as reoperations. RESULTS: Increased index level FA grade was more frequent after TDR versus nonoperative treatment (36%, 25/69 vs. 2%, 1/57 of patients, P < 0.001), but was not related to change in ODI or back pain. At follow-up, index level FA grades were higher after TDR versus nonoperative treatment (odds ratio 4.0 MRI and 5.9 CT), but were not related to ODI less than or equal to 22. Four patients (6%) treated with TDR and no patients treated nonoperatively were operated for lateral recess stenosis with posterior decompression at the index level during follow-up. CONCLUSION: Index level FA development was more likely after TDR compared with nonoperative treatment but was not associated with the 8-year clinical outcome. Index level FA may have contributed to reoperations in the TDR group. LEVEL OF EVIDENCE: 2.

[Cast immobilisation for suspected scaphoid fractures]. / Gips ved mistanke om skafoidfraktur.

BACKGROUND: Patients with suspected scaphoid fractures usually have their arm immobilised in a cast for two weeks, even in the absence of radiographic signs of fracture. After two weeks a new radiographic examination is performed. Our objective was to assess the extent of unnecessary cast immobilisation and to describe existing diagnostic practice in our hospital. MATERIAL AND METHODS: We performed a retrospective study to identify all patients treated for suspected scaphoid fracture in our hospital in the period 2001 - 2006. The extent of unnecessary immobilisation and the use of diagnostic procedures were assessed by systematic review of patients' medical records. RESULTS: 45 of 194 patients treated as if they had a scaphoid fracture were diagnosed with a fracture; 29 by plain radiographs at the first consultation and 16 at later consultations (nine by plain radiographs after two weeks, three by MRI after two weeks and four by repeated clinical assessments for maximum 10 weeks). 89 patients of working age and without scaphoid fracture were treated with cast immobilisation for 187 weeks in total. INTERPRETATION: Only 23 % of patients treated with cast immobilisation for two weeks were ultimately diagnosed with scaphoid fracture. The extent of unnecessary cast immobilisation indicates a need to use better diagnostic tools early after the injury.

Adjacent Disc Degeneration After Lumbar Total Disc Replacement or Nonoperative Treatment: A Randomized Study with 8-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.

Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial.

BACKGROUND CONTEXT: Lumbar total disc replacement (TDR) is a treatment option for selected patients with chronic low back pain (LBP) that is non-responsive to conservative treatment. The long-term results of disc replacement compared with multidisciplinary rehabilitation (MDR) have not been reported previously. PURPOSE: We aimed to assess the long-term relative efficacy of lumbar TDR compared with MDR. DESIGN: We undertook a multicenter randomized controlled trial at five university hospitals in Norway. PATIENT SAMPLE: The sample consisted of 173 patients aged 25-55 years with chronic LBP and localized degenerative changes in the lumbar intervertebral discs. OUTCOME MEASURES: The primary outcome was self-reported physical function (Oswestry Disability Index [ODI]) at 8-year follow-up in the intention-to-treat population. Secondary outcomes included self-reported LBP (visual analogue scale [VAS]), quality of life (EuroQol [EQ-5D]), emotional distress (Hopkins Symptom Checklist [HSCL-25]), occupational status, patient satisfaction, drug use, complications, and additional back surgery. METHODS: Patients were randomly assigned to lumbar TDR or MDR. Self-reported outcome measures were collected 8 years after treatment. The study was powered to detect a difference of 10 ODI points between the groups. The study has not been funded by the industry. RESULTS: A total of 605 patients were screened for eligibility, of whom 173 were randomly assigned treatment. Seventy-seven patients (90%) randomized to surgery and 74 patients (85%) randomized to rehabilitation responded at 8-year follow-up. Mean improvement in the ODI was 20.0 points (95% confidence interval [CI] 16.4-23.6, p≤.0001) in the surgery group and 14.4 points (95% CI 10.7-18.1, p≤.0001) in the rehabilitation group. Mean difference between the groups at 8-year follow-up was 6.1 points (95% CI 1.2-11.0, p=.02). Mean difference in favor of surgery on secondary outcomes were 9.9 points on VAS (95% CI 0.6-19.2, p=.04) and 0.16 points on HSCL-25 (95% CI 0.01-0.32, p=.04). There were 18 patients (24%) in the surgery group and 4 patients (6%) in the rehabilitation group who reported full recovery (p=.002). There were no significant differences between the groups in EQ-5D, occupational status, satisfaction with care, or drug use. In the per protocol analysis, the mean difference between groups was 8.1 ODI points (95% CI 2.3-13.9, p=.01) in favor of surgery. Forty-three of 61 patients (70%) in the surgery group and 26 of 52 patients (50%) in the rehabilitation group had a clinically important improvement (15 ODI points or more) from baseline (p=.03). The proportion of patients with a clinically important deterioration (six ODI points or more) was not significantly different between the groups. Twenty-one patients (24%) randomized to rehabilitation had crossed over and had undergone back surgery since inclusion, whereas 12 patients (14%) randomized to surgery had undergone additional back surgery. One serious adverse event after disc replacement is registered (<1%). CONCLUSIONS: Substantial long-term improvement can be expected after both disc replacement and MDR. The difference between groups is statistically significant in favor of surgery, but smaller than the prespecified clinically important difference of 10 ODI points that the study was designed to detect. Future research should aim to improve selection criteria for disc replacement and MDR.

[Heroin: a useful analgesic?]. / Heroin--et nyttig analgetikum?

BACKGROUND: In some countries, heroin is widely used as an analgesic agent. MATERIAL AND METHODS: The literature describing the history, pharmacology and analgesic use of heroin was reviewed. RESULTS: Heroin is a semi-synthetic morphine derivative. A century ago it was considered a panacea with numerous indications. Today it is best known as a drug of abuse, but is still in use as an analgesic. Most studies that compare heroin with other analgesics have methodological shortcomings; however, they generally indicate that heroin has a clinical effect not very different from morphine. An better aqueous solubility as compared to morphine may in some situations be advantageous. Because of a proposed incomplete cross-tolerance between heroin and other opioid analgesics, it may be used if the patient shows sub-therapeutic response to first-line opioids. INTERPRETATION: Although not well documented, heroin appears to be an effective analgesic with certain properties different from those of morphine. It may be of clinical value in conditions with acute and/or terminal pain.