Classification systems for the reporting of surgical complications have been developed and adapted for many surgical subspecialties. The purpose of this systematic review was to examine the variability and frequency of reporting terms used to describe complications in ankle fracture fixation. We hypothesized that the terminology used would be highly variable and inconsistent, corroborating previous results that have suggested a need for standardized reporting terminology in orthopaedics. Ankle fracture outcome studies meeting predetermined inclusion and exclusion criteria were selected for analysis by two independent observers. Terms used to define adverse events were identified and recorded. If a difference occurred between the two observers, a third observer was enlisted. Results of both observers were compared. All terms were then compiled and assessed for variability and frequency of use throughout the studies involved. Reporting terminology was subsequently grouped into 10 categories. In the 48 studies analyzed, 301 unique terms were utilized to describe adverse events. Of these terms, 74.4% (224/301) were found in a single study each. Only one term, “infection”, was present in 50% of studies, and only 19 of 301 terms (6.3%) were used in at least 10% of papers. The category that was most frequently reported was infection, with 89.6% of studies reporting on this type of adverse event using 25 distinct terms. Other categories were “wound healing complications” (72.9% of papers, 38 terms), “bone/joint complications” (66.7% of papers, 35 terms), “hardware/implant complications” (56.3% of papers, 47 terms), “revision” (56.3% of papers, 35 terms), “cartilage/soft tissue injuries” (45.8% of papers, 31 terms), “reduction/alignment issues” (45.8% of papers, 29 terms),“medical complications” (43.8% of papers, 32 terms), “pain” (29.2% of papers, 16 terms) and “other complications” (20.8% of papers, 13 terms). There was a 78.6% interobserver agreement in the identification of adverse terms across the 48 studies included. The reporting terminology utilized to describe adverse events in ankle fracture fixation was found to be highly variable and inconsistent. This variability prevents accurate reporting of adverse events and makes the analysis of potential outcomes difficult. The development of standardized reporting terminology in orthopaedics would be instrumental in addressing these challenges and allow for more accurate and consistent outcomes reporting

Abstract

Background

Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial.

Introduction

Quality measures play a substantial role in the Centers for Medicare and Medicaid Services' hospital payment and public reporting programs. The purpose of this study was to assess whether public measurement of total hip and knee arthroplasty risk-standardized readmission (RSRRs) and complication rates (RSCRs) was temporally associated with decreasing rates of adverse outcomes among Medicare beneficiaries.

Abstract

Different techniques have been described to address massive bone loss of the acetabulum in revision hip surgery. aMace has gained popularity as it provides customization aiming to restore hip centre and provide good initial stability in cases of large non-contained defects. It takes into account quality of host bone. Its porous defect filling scaffold provides an excellent surface for osteointegration.

Our aim was to assess the short and mid-term outcomes of patients who underwent revision surgery using aMace system.

Ethical approval was obtained. A retrospective study included all patients who had aMace between June 2013 and October 2022 allowing for a minimum of 12-months follow-up. Patients’ demographics, indication, bone-loss severity, reconstruction details, re-operation, complications, mortality, pain and function were assessed.

52 cases were performed by 13 surgeons with median 51 months follow-up. Median age was 72.7 years. 86.5% were female. Average BMI was 25.3. Average ASA grade was 3.

65% were classified as Paprosky IIIB and 32% were IIIA.

73% were found to have poor bone quality on CT. Main indication for aMace was massive bone loss/discontinuity secondary to aseptic loosening in 88.5%.

77% underwent single-stage revision. 53.8% had 2 or more previous revisions. 71% underwent stem revision in the same setting. 77% received a dual mobility bearing.

Re-operation rate was 5.7% for instability and femoral PPF. LLD was reported in 9.6%.

Permanent Sciatic nerve palsy occurred in 3.8% of the cases.

30-days mortality was 1.9%.

Statistically significant post-op improvements in pain and mobility were reported (p<0.001). None of the acetabular components have been revised.

Our study shows satisfactory surgical outcomes with a relatively low complication rate and significant pain and mobility improvements in the early to mid-term stages.

We recommend these costly cases to be done in highly specialist centres adopting MDT approach.

The histopathology of periprosthetic tissues has been important to understanding the relationship between wear debris and arthroplasty outcome. In a landmark 1977paper, Willert and Semlitsch (1) used a semiquantitative rating to show that tissue reactions largely reflected the extent of particulate debris. Notably, small amounts of debris, including metal, could be eliminated without “overstraining the tissues” but excess debris led to deleterious changes. Currently, a plethora of terms is used to describe tissues from metal-on-metal (M-M) hips and corroded modular connections. We reviewed the evaluation and reporting of local tissue reactions over time, and asked if a dose response has been found between metal and tissue features, and how the use of more standardized terms and quantitative methodologies could reduce the current confusion in terminology.

Review the complications reporting in 4 prominent spinal journals over the last decade.

Computerised search of the Medline database and hand search was undertaken to evaluate the complication reporting in 4 spinal journals (Spine, European Spine Journal, Journal of Neurosurgery Spine and Journal of Bone and joint surgery) from 2000 to 2009. The articles were divided based on the level of NICE evidence classification A to D.

A total of 88 articles reported spinal complications. Of these 5.9% was level B, 8.8% was level C and 85.3% was level D. There were no RCT's reported relating to complications (Level A) and majority of complications were case reports or expert opinions (level D). For the proportion of level D the rank order of the journals was; Spine (4.8%), European spine journal (3.8%), Journal of neurosurgery spine (5.1%) and Journal of bone and joint surgery was (1.8%). There was no increase in the rate of reporting over the decade. A detailed discussion of the reporting will be presented.

Papers focusing primarily on complications and its management are still not the focus in most surgical journals. This review over the last 10 years confirms that only rare and uncommon complications are reported in the form of case reports. Meta analysis or case series of complication is rarely reported. More focus must be emphasised on reporting mortality and morbidity for education.

Background and Purpose: Clinicians have expressed frustration at the difficulty of interpreting low back pain (LBP) trial outcomes. Using a suite of methods to report outcomes may aid interpretation and transition of research into practice. We aimed to facilitate consensus between LBP experts on how future trials are reported.

Methods and Results: We invited SBPR and LBP Forum members, and authors of LBP trials to participate. In the first round, participants were presented with results of a qualitative study on clinicians’ preferences for different reporting methods. They were asked to rate and comment on the appropriateness of including different reporting methods in a standardised set. In the second round, they reviewed other participants’ ratings and comments, re-rated methods, and edited a statement of recommendation for future reporting. In the final round, participants were asked if they approved of a revised statement. Consensus was measured using the RAND/UCLA appropriateness method and ratified in a meeting at LBP Forum X. Sixty-three experts participated in the study. Ninety-eight percent of participants approved a statement recommending that, where possible, results of LBP trials are reported using between-group mean differences (including advice on clinically important difference), proportion of patients improving in each group, NNT to achieve a minimally important change, and the proportion of deteriorating in each group (all with 95% CIs). Also, additional reporting methods were recommended according to needs of particular trials.

Conclusion: A high level of consensus was reached amongst LBP experts on a statement recommending a standardised set of reporting methods.

Conflict of Interest: None

Source of Funding: Barts and the London Charity

Low back pain is a very common complaint in medicolegal cases. However, and contrary to many other conditions, there are no objective medical exams that are able to help establish impairment rating.

Testing the function of the trunk may, however, help back pain assessment. Many different principles of trunk function testing have been described.

Range of motion (ROM)

Of all these techniques, isoinertial testing provides the closest simulation of natural movement and therefore seems the most appropriate for clinical trunk testing and assessment of spinal function.

Functional assessment may enable a good estimation of remaining functional status and therefore permits a reasonable measure of the functional loss compared with age and sex matched databases. Nevertheless, for this measure to be reliable and valid one must be sure that the subject exerted a maximal performance: a maximal voluntary effort. Only then can the measured function be used to assess handicap.

Different techniques have been elaborated to recognize maximal effort. The most accepted appears to be reliability (or reproducibility) of performance which postulates that impaired subjects will generate lower but reproducible performance. It has been well-validated in different areas of strength testing: hand grip, elbow flexors, knee extensors, shoulder press and posturography. In trunk testing, it has been established for isokinetic and isoinertial measures. A possible reliable submaximal performance has been shown to be possible in some specific conditions which are not usually found in low back pain sufferers. Furthermore, the measure of the coefficient of variance (CV), sometimes proposed, is not a reliable way to assess reproducibility of performance.

The meaning of submaximal performance must be carefully understood, it may be the result of many factors like misunderstanding of instructions, fear of reinjury, anxiety, psychological distress and in some cases symptom amplification or malingering. The latter hypothesis can only rarely be determined with a reasonable degree of certainty.

Instrumented function assessment can help to determine the degree of impairment in case of maximal effort. That is it’s major interest and use. A submaximal effort will not help to determine impairment but does not necessarily indicate a conscious attempt at symptom magnification or malingering, and requires further investigation. It cannot by itself inform the sincerity of the complainant. Functional assessment can be used to find a fair compensation in case of maximal effort. It cannot be used to chase so called “malingerers” if this effort is not realised. There is no such thing as a lie-detector of back function.

Aim: To determine any difference which may exist between the interpretation of nerve root compression demonstrated by an MRI scan as assessed by a radiologist compared to a spinal surgeon.

Introduction: There are a few standardized criteria for attempting to quantify the degree of lumbosacral nerve root compression demonstrated by radiological investigations. However, these are not validated and are not commonly employed. It is possible that the interpretation of films by surgeons is different to that by radiologists. If this is the case it could have important consequences, particularly if potential surgical targets are not recognised. We sought to investigate this potential discrepancy.

Method: Data from consecutive patients undergoing lumbosacral nerve root decompression, by a single surgeon, between 2002 and 2005 was prospectively analysed. Inclusion criteria were:

uni- or bilateral single level nerve root decompression

The MRI report of these patients was then scrutinised to see if the decompressed nerve root had been reported as significantly compressed on the pre-operative scan.

Results: Only 75 % of films had a formal radiological report. Of reported films 22% had not reported the surgical target which rose to 33% for L5 nerve root compression.

Conclusion: Consideration needs to be given to the potential placebo effect of surgery, the nature of the compressive pathology, the clinical details supplied to the radiologist and how the surgical decision making was made.

However, in this sample a large minority of MRIs had no formal report. Of those that were reported, there was underreporting of potential surgical targets by radiologists. This implies that there could be a high incidence of false negative MRI reporting with potentially treatable conditions being unrecognised.

The goals of perioperative management are to relieve pain, achieve early mobilization after surgery, reduce length of hospital stay, and obtain adequate patient satisfaction. Several treatment options combining systemic analgesics and/or regional analgesia with or without opioids are available for postoperative pain; however, a gold standard has not been established although there is a progressive shift towards multimodal approaches to improve analgesia while minimizing opioid-related side effects.

EX-TRA-05 (DAVID-ART) was a randomised, double-blind, parallel, pivotal study, evaluating the analgesic efficacy and safety of the innovative oral combination of dexketoprofen/tramadol 25mg/75mg in comparison with the individual components (tramadol given at the higher dose of 100mg) on moderate to severe acute pain after total hip replacement. Repeated doses of study drug were administered every 8 hours and pain intensity (PI) was to be scored according to a 100mm visual analogue scale (VAS) on a programmed e-diary every 2 hours over a 56-hour period (i.e. along 7 repeated doses). A placebo arm was included at the first administration to validate the pain model. Rescue medication, metamizole 500mg, was available during the treatment period. The study primary endpoint was the mean sum of the pain intensity difference values throughout the first 8 hours (SPID₈), which considered the 3 active treatment arms and placebo (ITT population; N=641). In this phase, a clear superiority of the combination over the single agents was demonstrated (p<0.05). An additional analysis was performed during the entire 0–56h repeated-dose period excluding those patients who had received placebo at the first dose (N=161). The estimated mean (SE) differences on PI-VAS over 24, 32 and 56 hours post first dose (0–24h, 0–32h, and 0–56h) between the combination and each single agent were evaluated.

Patients who received active analgesic from the first dose (mITT population; N=480) were aged 29–80 years (42% were ≥65 years). At randomisation, pain was moderate (≥40–60mm) in 51% patients and severe (>60mm) in 49%. For dexketoprofen/tramadol, mean (SD) PI-VAS values were 22 (4.0) over 24 hours; 21 (4.1) over 32 hours; and 19 (3.8) over 56 hours. The estimated differences versus dexketoprofen 25mg and tramadol 100mg were respectively 10 (0.7) and 7.6 (0.7) over 24 hours; 9.8 (0.6) and 7.2 (0.6) over 32 hours; and 8.1 (0.5) and 6.3 (0.5) over 56 hours (p<0.0001 for all comparisons), which confirmed the superiority of the combination versus both single agents throughout the periods analysed.

This significant higher decrease of PI favouring dexketoprofen/tramadol 25mg/75mg over dexketoprofen 25mg and tramadol 100mg, all given every 8 hours, during the first 56 hours post dose confirmed the superior analgesia shown after the first 0–8h post-dose period. The combination of dexketoprofen/tramadol 25mg/75mg is able to provide a level of analgesia above that achievable by each component alone, with a sustained effect when used as a multiple-dose regimen. The addition of this new combo to the analgesic armamentarium may contribute to facilitate early mobilization after surgery, thus positively impacting perioperative co-morbidities and length of in-hospital stay.

To promote cultural awareness and acceptance of clinical governance by developing a simple, reproducible model for reporting critical incidents and near misses within our department.

An A4 sized departmental proforma was developed to parallel the Trust’s official adverse incident register. Prospective reporting of adverse events using the proforma was encouraged between August 2000 and June 2001. Incidents were discussed in an anonymised and a blame-free setting, at the monthly multidisciplinary clinical governance meeting and appropriate action taken.

In the 6 months prior to commencing this study only 4 adverse events were reported with no discernible action taken. Following the introduction of the proforma 61 critical incidents and near misses were reported in the period August 2000 to June 2001. As a result of effective reporting of adverse events we have developed a number of protocols to improve patient care.

A simple model for reporting critical incidents and near misses has been established. This has fostered a cultural change within the department and all members of staff feel more comfortable with reporting such incidents. The process is seen as educational and an important part of continuing professional and departmental development. Protocols and changes in organisational practice have been developed to reduce and prevent the occurrence of adverse events and offer our patients continuous improvement in care.

Introduction: Registration of complications in a Department of Orthopaedic Surgery or Traumatology has always been the concern of surgeons as a simple feedback to improve the quality of care they provide to their patients. However, it has not been made through a systematic approach in Switzerland to date. The literature shows only one study which proposes to set up a database and software for general surgery complications.

The purpose of this study was to show the feasibility of setting up a computerized register of complications for a whole Department of Orthopaedic Surgery and Traumatology, based on a simple, user-friendly and upto-date scientific approach.

Methods: After a systematic literature review, the definitions, types and classification of complications were determined. A protocol for data registration was defined as well as the tasks for the people involved. A client-server software was chosen and further developped, in close collaboration with the Information Technology Department to benefit from an automatic download of patients’ administrative data.

Results: The classification of complications by de Waal Maletfijt was adapted and the coefficient of severity proposed by Clavien was used. A definition of each complication was communicated to all staff involved. A self-developed Microsoft Access application with a local database as back-end was developed. A new strategy to capture the complications efficiently was developed and used after staff approval. Data collection was done before surgery (prehospitalisation), on the day of surgery and after the operation until the end of the stay in hospital.

Conclusions: This systematic approach to record complications was found feasible, efficient and a useful tool for the assessment of quality of care.

The Ionising Radiation (Medical Exposure) Regulations 2000 is concerned with: “the making of safety measures in regard to radioactive substances and the emission of ionising radiation”. Responsibility is placed upon the Practitioner, Operator, Referrer and employer. A clinical evaluation of the outcome of each medical exposure must be recorded.” In Ayr Hospital Radiologist report A&E radiographs but not those in fracture clinic unless a specific request was made. Therefore the Surgeon/Trainee must record their interpretation.

An audit was completed to review the rate of documentation of the interpretation of radiographs in the clinical records of consecutive patients attending fracture clinics Notes and radiographs were reviewed from 6 separate fracture clinics. 106 patients attended during the time period and were seen by 9 different surgeons; 5 consultants and 4 training grade surgeons. 46 out of 106 patients were x-rayed and interpretation recorded in 38 cases. No interpretation was found in 8 cases, giving an overall compliance of 82.6% with no difference between different grades of surgeon: Consultants 79.2% (19/24); Trainees 86.4% (19/22).

These finding were presented at a departmental audit meeting and the audit loop was then closed by a second period of audit with an improvement in the consultants compliance to 100% (22/22) p=0.05 and no significant change in the trainees performance 75% (18/24).

Background and Purpose: How outcomes of clinical trials are reported alters the way treatment effectiveness is perceived. Clinicians interpret outcomes of trials more favourably when results are presented in relative rather than in absolute terms. However, the face validity of different methods is unclear. We aimed to explore which methods clinicians find clearest, most interpretable, and useful.

Methods and Results: We purposively sampled clinicians who see patients with low back pain (LBP) and presented them with summary reports of a hypothetical trial, reporting the results using a variety of different methods. We explored participants’ preferences for these different methods and how they would like to see future trials reported. We interviewed 14 clinicians (GPs, manual therapists, psychologists, a rheumatologist, and surgeons). Participants felt that clinical trial reports were not written with them in mind. They were familiar with mean differences, proportion improved, and number needed to treat (NNT); and unfamiliar with standardised mean difference (SMD), odds ratios and relative risk. They found the proportion improved, relative risk and NNT more intuitively understandable, and were concerned that between-group mean difference, relative risk and odds ratios may mislead. Participants thought each method uniquely contributed to their overall understanding, and that using a variety of methods to report future trials may prevent erroneous portrayal of treatment effect.

Conclusion: Clinicians who see patients with low back pain currently find it difficult to interpret LBP trials. Using a suite of methods to report outcomes may aid clinicians’ interpretation and the transition of research into practice.

Conflict of Interest: None

Sources of Funding: Barts and the London Charity

Background: The interpretation of safety data from clinical studies such as complication risks requires clear definition of targeted and documented complication events. In addition a standardized classification of complications is required to allow appropriate comparison of safety data between studies and treatment groups. This presentation highlights a proposal for a standardized management and classification of complication data to initiate and seek consensus among trauma surgeons active in clinical documentation and research.

Methods: Complication events are examined regarding their timing of occurrence as well as their potential causal inter-relationship for any given patient. While independent events are numbered sequentially, directly associated events (e.g. a fracture collapse and implant screw perforation into a joint) receives the same complication number. Complications are described and categorized according to a pre-defined list of anticipated complication types, or as un-anticipated complications. They are further classified as local or general; local complications occur at or directly around the injuries and are further classified as being “Implant/Surgical procedure”, “Bone/Fracture” or “Soft tissue/Wound” events. Information regarding their operative and/or non-operative treatment and their outcome is recorded. Further assessments are made regarding their seriousness, their relation to the implant used. Final classification of complication events is better determined after independent review by a panel of experienced clinicians.

Results: Our classification process was applied successfully to a series of clinical studies at our department. In a study of 185 distal radius fractures treated by LCP, at least one complication occurred in 21 patients, and in seven cases there was a combination of associated events (e.g. one CTS with tendon rupture). Complication risks ranging from 0% to 11.4% were noted depending on which complications and time frames were considered. There was no risk to obtain a LCP implant specific related complication, whereas the risk for a local complication within 6 months after surgery was 6% (95% CI: 3% – 11%).

Conclusions: This management and classification system proved valuable in the documentation and analysis of safety data from clinical studies. It facilitates communication and understanding of definitions between clinicians, as well as allows a prompt, standardised and accurate analysis and reporting of complication events and risks. We encourage other clinical researchers and professionals to participate in the further development and acceptance of a universal classification system for complications in traumatology and orthopaedics.

Background

The prevalence estimates of LBP are so far well documented. However, only few longitudinal studies have described the variability of LBP in the same population over time. Therefore, little is known about the course of LBP at the individual level.