Comparison of Patients Operated for Lumbar Spinal Stenosis with and without Spondylolisthesis - A Secondary Analysis of the NORDSTEN Trials.

STUDY DESIGN: Observational cohort study (secondary analysis of two randomized trials). OBJECTIVE: To investigate whether function, disability, pain and quality of life before surgery and patient-reported outcome as well as complication and reoperation rates up to two years after surgery differ between lumbar spinal stenosis patients with and without spondylolisthesis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is a degenerative condition of the spine, which appears with or without degenerative spondylolisthesis often presenting similar signs and symptoms. METHOD: This study is a secondary analysis of two randomized trials on patients with lumbar spinal stenosis with and without spondylolisthesis conducted at 16 public Norwegian hospitals. Disability, function, back pain, leg pain, quality of life, complication and reoperation rates up to two years after surgery were compared between the two cohorts. RESULTS: A total of 704 patients were included in this study, 267 patients with spondylolisthesis (median age 67.0 years [IQR 61.0-72.0]; 68.7% female) and 437 patients without spondylolisthesis (median age 68.0 years IQR 62.0-73.0]; 52.9% female). In the linear mixed model analysis there were no significant differences in disability, function, back pain, leg pain and quality of life scores between the two cohorts of patient with and without spondylolisthesis before surgery or at two years follow-up. The complication rate was 22.9% in patients with spondylolisthesis and 12.1% in patients without spondylolisthesis (P<0.001). There were no significant differences in reoperation rates. CONCLUSION: In patients with lumbar spinal stenosis the symptom burden before surgery and the clinical outcome up to two years after surgery were similar independently of a concomitant spondylolisthesis.

Preoperative CT improves the assessment of stability in trochanteric hip fractures.

Aims: To investigate if preoperative CT improves detection of unstable trochanteric hip fractures. Methods: A single-centre prospective study was conducted. Patients aged 65 years or older with trochanteric hip fractures admitted to Stavanger University Hospital (Stavanger, Norway) were consecutively included from September 2020 to January 2022. Radiographs and CT images of the fractures were obtained, and surgeons made individual assessments of the fractures based on these. The assessment was conducted according to a systematic protocol including three classification systems (AO/Orthopaedic Trauma Association (OTA), Evans Jensen (EVJ), and Nakano) and questions addressing specific fracture patterns. An expert group provided a gold-standard assessment based on the CT images. Sensitivities and specificities of surgeons' assessments were estimated and compared in regression models with correlations for the same patients. Intra- and inter-rater reliability were presented as Cohen's kappa and Gwet's agreement coefficient (AC1). Results: We included 120 fractures in 119 patients. Compared to radiographs, CT increased the sensitivity of detecting unstable trochanteric fractures from 63% to 70% (p = 0.028) and from 70% to 76% (p = 0.004) using AO/OTA and EVJ, respectively. Compared to radiographs alone, CT increased the sensitivity of detecting a large posterolateral trochanter major fragment or a comminuted trochanter major fragment from 63% to 76% (p = 0.002) and from 38% to 55% (p < 0.001), respectively. CT improved intra-rater reliability for stability assessment using EVJ (AC1 0.68 to 0.78; p = 0.049) and for detecting a large posterolateral trochanter major fragment (AC1 0.42 to 0.57; p = 0.031). Conclusion: A preoperative CT of trochanteric fractures increased detection of unstable fractures using the AO/OTA and EVJ classification systems. Compared to radiographs, CT improved intra-rater reliability when assessing fracture stability and detecting large posterolateral trochanter major fragments.

Assessing the content validity of the Manchester-Oxford Foot Questionnaire in surgically treated ankle fracture patients: a qualitative study.

BACKGROUND: Roughly 10% of fractures in adults are ankle fractures. These injuries are found in both sexes and present with different fracture characteristics. The treatment varies with the patients' biology and fracture type, and the goals are to restore stability, prevent pain and maintain ankle function. Clinicians generally use outcomes like assessment of radiography, pain level, or function. The use of patient-reported outcome measures is increasing, and the Manchester-Oxford Foot Questionnaire (MOXFQ) has been shown to have good measurement properties when validated in patients with foot and ankle disorders. However, the instrument has not been validated for ankle fracture patients. This study aims to assess the content validity of the items in MOXFQ in surgically treated ankle fracture patients. METHODS: A qualitative deductive design was used to investigate patients' response process of the MOXFQ. Individual interviews were conducted using cognitive interviewing based on the theoretical framework of the 4-step model by Tourangeau. Adult patients that were surgically treated for an ankle fracture between four weeks and 18 months were purposively sampled, and interviews followed a semi-structured interview guide. The predetermined categories were comprehension, retrieval, judgement, and response. RESULTS: Seventeen respondents (65% females) were interviewed. Respondents' age ranged from 27 to 76 years. Some of the respondents in the early recovery phase were limited by post-operative restrictions and did not find the items in the walking/standing domain relevant. Respondents that were allowed weight-bearing as tolerated (WBAT) were able to recall relevant information for most items. Respondents with time since surgery more than 12 months had less pain and remembered fewer relevant episodes in the recall period. Items in the social interaction domain contained ambiguous questions and were generally considered less important by respondents. The summary index score lacked important concepts in measuring overall quality of life. CONCLUSIONS: Pain was a central concept in the post-operative recovery of ankle fracture patients. The MOXFQ-subscales for pain and walking/standing had acceptable content validity in patients that were allowed WBAT. The social interaction-subscale and the summary index score had insufficient content validity for this patient population.

Improving the quality of the fracture liaison service through the implementation of a structured health record.

OBJECTIVE: According to the best practice framework for secondary fracture prevention, all patients aged ≥50 years with a fracture should be assessed for osteoporosis within the fracture liaison service (FLS). The framework includes an FLS quality registry database to ensure quality. The input of data into our FLS registry was time-consuming and required entering data twice: into both the journal record and the registry. A '3-in-1' solution was required: (1) developing a structured health record (SHR) to provide decision-support to FLS nurses during patient consultations; (2) making a structured journal record from the SHR and (3) exporting data to the quality registry database. The SHR needed to be web based, secure and available for use all over the world. DESIGN: One provider at Stavanger University Hospital met all the criteria for further development of the record (CheckWare). An interdisciplinary working group was established, following the Plan-Do-Study-Act working model. Depending on the answers given, the FLS nurses were provided decision-making support. A significant loss of height (≥4 cm) was highlighted as one of the process quality indicators. All clinically relevant data were summarised in a report, which was exported to the health record software. Data were exported to the FLS quality registry. RESULTS: All fracture patients in need of a dual-energy X-ray absorptiometry scan received an appointment at the FLS outpatient clinic and 96% attended. The minimum standard was met for the three quality indicators 1-3). In particular, the use of SHRs increased the number of patients investigated for vertebral fractures with a height loss ≥4 cm from 67% to 93%. CONCLUSION: The SHR was successful in regard to the '3-in-1' solution: providing decision support to FLS nurses, developing structured journal records and exporting data to the FLS quality registry. After implementation, all FLS registry quality indicators improved.

Ankle fractures: a systematic review of patient-reported outcome measures and their measurement properties.

PURPOSE: Ankle fractures are commonly occurring fractures, especially in the aging population, where they often present as fragility fractures. The disease burden and economic costs to the patient and society are considerable. Choosing accurate outcome measures for the evaluation of the management of ankle fractures in clinical trials facilitates better decision-making. This systematic review assesses the evidence for the measurement properties of patient-reported outcome measures (PROMs) used in the evaluation of adult patients with ankle fractures. METHODS: Searches were performed in CINAHL, EMBASE, Medline and Google Scholar from the date of inception to July 2021. Studies that assessed the measurement properties of a PROM in an adult ankle fracture population were included. The included studies were assessed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of PROMs. RESULTS: In total, 13 different PROMs were identified in the 23 included articles. Only the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) presented some evidence on content validity. The Olerud-Molander Ankle Score (OMAS) and Self-reported Foot and Ankle Score (SEFAS) displayed good evidence of construct validity and internal consistency. The measurement properties of the OMAS, LEFS and SEFAS were most studied. CONCLUSION: The absence of validation studies covering all measurement properties of PROMs used in the adult ankle fracture population precludes the recommendation of a specific PROM to be used in the evaluation of this population. Further research should focus on validation of the content validity of the instruments used in patients with ankle fractures.

Data entry quality of double data entry vs automated form processing technologies: A cohort study validation of optical mark recognition and intelligent character recognition in a clinical setting.

BACKGROUND AND AIMS: Patient-reported outcome measures (PROMs) are increasingly used in health services. Paper forms are still often used to register such data. Manual double data entry (DDE) has been defined as the gold standard for transferring data to an electronic format but is laborious and costly. Automated form processing (AFP) is an alternative, but validation in a clinical context is warranted. The study objective was to examine and validate a local hospital AFP setup. METHODS: Patients over 18 years of age who were scheduled for knee or hip replacement at Stavanger University Hospital from 2014 to 2017 who answered PROMs were included in the study and contributed PROM data. All paper PROMs were scanned using the AFP techniques of optical mark recognition (OMR) and intelligent character recognition (ICR) and were processed by DDE by health secretaries using a data entry program. OMR and ICR were used to capture different types of data. The main outcome was the proportion of correctly entered numbers, defined as the same response recorded in AFP and DDE or by consulting the original paper questionnaire at the data field, item, and PROM level. RESULTS: A total of 448 questionnaires from 255 patients were analyzed. There was no statistically significant difference in error proportions per 10 000 data fields between OMR and DDE for data from check boxes (3.52 95% confidence interval (CI) 2.17 to 5.72 and 4.18 (95% CI 2.68-6.53), respectively P = .61). The error proportion for ICR (nine errors) was statistically significantly higher than that for DDE (two errors), that is, 3.53 (95% CI 1.87-6.57) vs 0.78 (95% CI 0.22-2.81) per 100 data fields/items/questionnaires; P = .033. OMR (0.04% errors) outperformed ICR (3.51% errors; P < .001), Fisher's exact test. CONCLUSIONS: OMR can produce an error rate that is comparable to that of DDE. In our setup, ICR is still problematic and is highly dependent on manual validation. When AFP is used, data quality should be tested and documented.

Can bone apposition predict the retention force of a femoral stem? An experimental weight-bearing hip-implant model in goats.

BACKGROUND: The increasing incidence of prosthesis revision surgery in the Western world has led to an increased focus on the capacity for stem removal. We previously reported on a femoral stem implanted in goats with an approximate 15% reduction in retention force by drilling longitudinally orientated grooves on the side of the stem. In this current study, we aimed to histologically evaluate the bony apposition towards this stem and correlate this apposition with the pullout force. METHODS: We analyzed the femora of 22 goats after stem removal. All stems remained in place for 6 months, and the goats were allowed regular loading of the hip during this time. For histological evaluation, all femora were immersed in EDTA and decalcified until sufficiently soft for standard technique preparation. We evaluated bone apposition, the presence of foreign particle debris and other factors. The apposition was evaluated with a scoring system based on semi-quantitative bone apposition in four quadrants. Kappa statistics were calculated for the score. We correlated the retention force with the amount of bone apposition. RESULTS: The stem drilling was the only significant factor influencing the retention force (p = 0.020). The bone apposition Kappa score comparing poor and good apposition scores was fair (κ = 0.4, 95% CI 0.00-0.88). Signs of foreign body reaction were noted in 5 of 22 goats. CONCLUSIONS: Based on the current findings in an experimental goat model, it appears that the effect of drilling tissue/bone out of the longitudinal grooves has a more significant impact on the retention force required to remove the stem than the amount of bone apposition outside the stem grooves. This observation may be further explored in the research of stem designs that are potentially easier to remove.

Assessment of retention force and bone apposition in two differently coated femoral stems after 6 months of loading in a goat model.

BACKGROUND: Since the introduction of uncemented hip implants, there has been a search for the best surface coating to enhance bone apposition in order to improve retention. The surface coating of the different stems varies between products. The aim was to assess the retention force and bone adaption in two differently coated stems in a weight-bearing goat model. MATERIALS AND METHODS: Hydroxyapatite (HA) and electrochemically deposited calcium phosphate (CP; Bonit) on geometrically comparable titanium-based femoral stems were implanted into 12 (CP group) and 35 (HA group) goats. The animal model included physiological loading of the implants for 6 months. The pull-out force of the stems was measured, and bone apposition was microscopically evaluated. RESULTS: After exclusion criteria were applied, the number of available goats was 4 in the CP group and 11 in the HA group. The CP-coated stems had significantly lower retention forces compared with the HA-coated ones after 6 months (CP median 47 N, HA median 1,696 N, p = 0.003). Bone sections revealed a lower degree of bone apposition in the CP-coated stems, with more connective tissue in the bone/implant interface compared with the HA group. CONCLUSION: In this study, HA had better bone apposition and needed greater pull-out force in loaded implants. The application of CP on the loaded titanium surface to enhance the apposition of bone is questioned.

Reliable classification of children's fractures according to the comprehensive classification of long bone fractures by Müller.

BACKGROUND AND PURPOSE: Guidelines for fracture treatment and evaluation require a valid classification. Classifications especially designed for children are available, but they might lead to reduced accuracy, considering the relative infrequency of childhood fractures in a general orthopedic department. We tested the reliability and accuracy of the Müller classification when used for long bone fractures in children. METHODS: We included all long bone fractures in children aged < 16 years who were treated in 2008 at the surgical ward of Stavanger University Hospital. 20 surgeons recorded 232 fractures. Datasets were generated for intra- and inter-rater analysis, as well as a reference dataset for accuracy calculations. We present proportion of agreement (PA) and kappa (K) statistics. RESULTS: For intra-rater analysis, overall agreement (κ) was 0.75 (95% CI: 0.68-0.81) and PA was 79%. For inter-rater assessment, K was 0.71 (95% CI: 0.61-0.80) and PA was 77%. Accuracy was estimated: κ = 0.72 (95% CI: 0.64-0.79) and PA = 76%. INTERPRETATION: The Müller classification (slightly adjusted for pediatric fractures) showed substantial to excellent accuracy among general orthopedic surgeons when applied to long bone fractures in children. However, separate knowledge about the child-specific fracture pattern, the maturity of the bone, and the degree of displacement must be considered when the treatment and the prognosis of the fractures are evaluated.

How reliable and accurate is the AO/OTA comprehensive classification for adult long-bone fractures?

BACKGROUND: Reliable classification of fractures is important for treatment allocation and study comparisons. The overall accuracy of scoring applied to a general population of fractures is little known. This study aimed to investigate the accuracy and reliability of the comprehensive Arbeitsgemeinschaft für Osteosynthesefragen/Orthopedic Trauma Association classification for adult long-bone fractures and identify factors associated with poor coding agreement. METHODS: Adults (>16 years) with long-bone fractures coded in a Fracture and Dislocation Registry at the Stavanger University Hospital during the fiscal year 2008 were included. An unblinded reference code dataset was generated for the overall accuracy assessment by two experienced orthopedic trauma surgeons. Blinded analysis of intrarater reliability was performed by rescoring and of interrater reliability by recoding of a randomly selected fracture sample. Proportion of agreement (PA) and kappa (κ) statistics are presented. Uni- and multivariate logistic regression analyses of factors predicting accuracy were performed. RESULTS: During the study period, 949 fractures were included and coded by 26 surgeons. For the intrarater analysis, overall agreements were κ = 0.67 (95% confidence interval [CI]: 0.64-0.70) and PA 69%. For interrater assessment, κ = 0.67 (95% CI: 0.62-0.72) and PA 69%. The accuracy of surgeons' blinded recoding was κ = 0.68 (95% CI: 0.65- 0.71) and PA 68%. Fracture type, frequency of the fracture, and segment fractured significantly influenced accuracy whereas the coder's experience did not. CONCLUSIONS: Both the reliability and accuracy of the comprehensive Arbeitsgemeinschaft für Osteosynthesefragen/Orthopedic Trauma Association classification for long-bone fractures ranged from substantial to excellent. Variations in coding accuracy seem to be related more to the fracture itself than the surgeon. LEVEL OF EVIDENCE: Diagnostic study, level I.

Steppingstones to the implementation of an inhospital fracture and dislocation registry using the AO/OTA classification: compliance, completeness and commitment.

BACKGROUND: Musculoskeletal trauma represents a considerable global health burden, however reliable population-based incidence data are scarce. A fracture and dislocation registry was established within a well-defined population. An audit of the establishment process, feasibility of the registry work and report of the collected data is given. METHODS: Demographic data, fracture type and location, mode of treatment, and the reasons for the secondary procedures were collected and scored using recognized systems, such as the AO/OTA classification and the Gustilo-Anderson classification for open fractures. The reporting was done in the operation planning program by the involved orthopaedic surgeon. Both inpatient and day-case procedures were collected. Data were collected prospectively from 2006 until 2010. Compliance among the surgeons and completeness and accuracy of the data was continuously assured by an orthopaedic surgeon. RESULTS: During the study period, 39 orthopaedic surgeons were involved in the recording of a total of 8,188 procedures, consisting of primary treatment of 4,986 long bone fractures, 467 non long bone fractures, 123 dislocations and 2,612 secondary treatments. In the study period 532 fractures or dislocations were treated at least once for one or more serious complications. For the index year of 2009, a total of 5710 fractures or dislocations were treated in the emergency department or hospitalized, of which the 1594 (28%) were treated at the inpatient or day-case operation rooms, thus registered in the FDR. Quality assurance, educational incentives and continuous feedback between coders and controller in the integrated electronic system are available and used through the features of the electronic database. CONCLUSIONS: Implementing an integrated registry of fractures and dislocations with the electronic hospital system has been possible despite several users involved. The electronic system and the data controller provide for completeness and validity. The FDR has become an indispensable tool for the department for planning and education and will serve as a prerequisite for the conduct and execution of future prospective trials within the department. Further, other departments with similar electronic patient files may fairly easily adopt this system for implementation.

Incidence of traumatic long-bone fractures requiring in-hospital management: a prospective age- and gender-specific analysis of 4890 fractures.

BACKGROUND: Musculoskeletal trauma represents a considerable global health burden; however, reliable population-based incidence data are lacking. Thus, we prospectively investigated the age- and sex-specific incidence patterns of long-bone fractures in a defined population. METHODS: A 4-year prospective study of all long-bone fractures in a defined Norwegian population was carried out. The demographic data, as well as data on fracture type and location and mode of treatment were collected using recognised classification (e.g., AO/OTA - Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association; Gustilo-Anderson (GA) for open fractures). Age- and sex-adjusted incidences were calculated using population statistics. RESULTS: During the study period, 4890 long-bone fractures were recorded. The overall incidence per 100,000 per year was 406 with a 95% confidence interval (95%CI) of 395-417. The age-adjusted incidence for those <16 years (339; 95%CI: 318-360) was lower than that for those >or=16 years (427; 95%CI: 414-440). The overall male incidence (337; 95%CI: 322-355) was lower than the female (476; 95%CI: 459-493), but the male:female ratio was 2:1 among those <50 years, and 1:3 in those >or=50 years. The upper limb fractures had an overall incidence of 159 (95%CI: 152-166), whereas the lower limb fracture incidence was 247 (95%CI: 238-256). Open fractures occurred in 3%, with an incidence of 13 (95%CI: 11-15). Paediatric fractures were more likely to be treated conservatively with only 8% requiring internal fixation, compared to 56% internal fixation in those >or=16 years of age. An increase in the use of angular stable plates occurred during the study period. CONCLUSION: This prospectively collected study of long-bone fractures in a defined population recognises age- and gender-specific fracture patterns. Boys predominate in the younger age group for which treatment is basically conservative. In the senior population, women and operative treatment predominate.

[Risk intervention in persons with diabetes mellitus in general practice]. / Risikointervensjon ved diabetes i allmennpraksis.

BACKGROUND: Intervention against cardiovascular risk factors such as hypertension, dyslipidaemia and smoking is necessary to reduce the increased mortality associated with diabetes mellitus. METHODS: The case notes of 2003 patients with diabetes in general practice in Rogaland, Salten and Aker were reviewed in order to assess the quality of diabetes care including the treatment of risk factors for cardiovascular disease. RESULTS: 287 out of 1417 patients below the age of 76 had known cardiovascular disease. Of these, 57.5% were treated with a statin and 61 % were taking aspirin. 118 patients had had a myocardial infarction, 69.5% were on a statin and 60.2% were taking aspirin. 776 (38.7%) of the patients in the study had been diagnosed as suffering from hypertension, 40.3% were on therapy with one anti-hypertensive agent, 28.6% received two agents and 12.1% were on three or more anti-hypertensive agents. Only 57.5% of patients, who according to current national guidelines ought to be on a statin as secondary prevention, received such a treatment. Smoking habits were recorded in 35.1% and weight in 45 % of the patients. INTERPRETATION: There is considerable room for improvement with regard to intervention against known risk factors for cardiovascular disease in patients with diabetes treated in primary care.