Surgical or non-surgical treatment of traumatic skeletal fractures in adults: systematic review and meta-analysis of benefits and harms.

BACKGROUND: A comprehensive overview of treatments of common fractures is missing, although it would be important for shared decision-making in clinical practice. The aim was to determine benefits and harms of surgical compared to non-surgical treatments for traumatic skeletal fractures. METHODS: We searched Medline, Embase, CINAHL, Web of Science, and CENTRAL until November 2018, for randomized trials of surgical treatment in comparison with or in addition to non-surgical treatment of fractures in adults. For harms, only trials with patient enrollment in 2000 or later were included, while no time restriction was applied to benefits. Two reviewers independently assessed studies for inclusion, extracted data from full-text trials, and performed risk of bias assessment. Outcomes were self-reported pain, function, and quality of life, and serious adverse events (SAEs). Random effects model (Hedges' g) was used. RESULTS: Out of 28375 records screened, we included 61 trials and performed meta-analysis on 12 fracture types in 11 sites: calcaneus, clavicula, femur, humerus, malleolus, metacarpus, metatarsus, radius, rib, scaphoideum, and thoraco-lumbar spine. Seven other fracture types only had one trial available. For distal radius fractures, the standardized mean difference (SMD) was 0.31 (95% CI 0.10 to 0.53, n = 378 participants) for function, favoring surgery, however, with greater risk of SAEs (RR = 3.10 (1.42 to 6.77), n = 436). For displaced intra-articular calcaneus fractures, SMD was 0.64 (0.13 to 1.16) for function (n = 244) and 0.19 (0.01 to 0.36) for quality of life (n = 506) favoring surgery. Surgery was associated with a smaller risk of SAE than non-surgical treatment for displaced midshaft clavicular fractures (RR = 0.62 (0.42 to 0.92), n = 1394). None of the other comparisons showed statistical significance differences and insufficient data existed for most of the common fracture types. CONCLUSIONS: Of 12 fracture types with more than one trial, only two demonstrated a difference in favor of surgery (distal radius fractures and displaced intra-articular calcaneus fractures), one of which demonstrated a greater risk of harms in the surgical group (distal radius fractures). Our results highlight the current paucity of high-quality randomized trials for common fracture types and a considerable heterogeneity and risk of bias in several of the available trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015020805.

Highly impacted bone allograft may allow immediate weight bearing in tibial plateau fractures: A case report.

INTRODUCTION: Proximal tibial fractures are common with an incidence of 10.2/100.000. Those displaced and involving the articular surface will often require surgical treatment. However, no consensus exists on whether to allow the patient early weight bearing or not. We developed a technique using structural bone chips, highly impacted under the articular surface, to permit immediate weight bearing after surgery. PATIENT: The patient was a 44-year old male who suffered a lateral tibial plateau fracture (AO type 41B2). INTERVENTION: We used an anterolateral approach with an S-shaped incision. A small window in the tibia was made using an awl, and the articular surface was reduced under radiographic imaging. The bone allograft was prepared by splitting the frozen femoral head in quarters and then taking large pieces of bone with a bone rongeur forceps avoiding the cartilage. The large pieces of bone were gathered in a small tray and thereafter compressed into the drill guide insert. The drill guide filled with bone graft was then inserted into the tibia window and directed in the appropriate position guided by radiography. Hereafter, the bone graft was impacted under the articular surface with force using the appropriate trocar and a hammer, and the fracture was finally reduced. Finally, the fracture was fixated utilizing an angular stable plate. OUTCOME: The patient was followed up one year postoperatively and allowed immediate weight bearing after surgery. No subsequent articular collapse occurred. DISCUSSION: In this case, we present a proximal tibial fracture with articular depression, which was surgically treated with a highly impacted bone allograft of large pieces and a locking plate. The patient was allowed immediate weight bearing and no subsequent articular collapse occurred.

Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis.

INTRODUCTION: Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment. METHODS AND ANALYSIS: An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs' characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health. ETHICS AND DISSEMINATION: All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42017067240.

Middle-aged patients with an MRI-verified medial meniscal tear report symptoms commonly associated with knee osteoarthritis.

Background and purpose - No consensus exists on when to perform arthroscopic partial meniscectomy in patients with a degenerative meniscal tear. Since MRI and clinical tests are not accurate in detecting a symptomatic meniscal lesion, the patient's symptoms often play a large role when deciding when to perform surgery. We determined the prevalence and severity of self-reported knee symptoms in patients eligible for arthroscopic partial meniscectomy due to a degenerative meniscal tear. We investigated whether symptoms commonly considered to be related to meniscus injury were associated with early radiographic signs of knee osteoarthritis. Patients and methods - We included individual baseline items from the Knee injury and Osteoarthritis Outcome Score collected in 2 randomized controlled trials evaluating treatment for an MRI-verified degenerative medial meniscal tears in 199 patients aged 35-65 years. Each item was scored as no, mild, moderate, severe, extreme, and at least "mild" considering the symptoms present. Early radiographic signs of osteoarthritis, defined as a Kellgren and Lawrence grade of at least 1, were seen in 70 patients. Results - At least monthly knee pain, pain during stair walking and when twisting on the knee, and lack of confidence in knee was present in at least 80% of the patients. Median severity was at least moderate for knee pain, pain when twisting on the knee, pain walking on stairs, lack of confidence in knee, and clicking. Mechanical symptoms such as catching were rare. Early radiographic signs of osteoarthritis were associated with an increased risk of self-reported swelling, catching, and stiffness later in the day; the odds ratio was 2.4 (95% CI 1.2-4.9), 2.3 (1.2-4.3), and 2.3 (1.1-5.0), respectively. Interpretation - Middle-aged patients with a degenerative medial meniscus tear reported symptoms commonly associated with knee osteoarthritis. Frequent knee pain, presence of lack of confidence in the knee, and clicking did not distinguish those with a meniscal tear alone from those with early radiographic knee OA. Our findings support the notion that symptoms reported by those with a degenerative meniscal tear represent early signs of knee osteoarthritis.

The challenge of recruiting patients into a placebo-controlled surgical trial.

BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial, and to identify reasons associated with participation in a placebo-controlled randomized surgical trial. METHODS: Data were extracted from an ongoing placebo-controlled randomized controlled trial (RCT) on meniscectomy versus placebo surgery. We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT. Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation. RESULTS: A total of 476 patients entered the screening group, of which 190 patients fulfilled the inclusion and exclusion criteria. 102 patients declined to participate in the study due to various reasons and 46 were later excluded (no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent). A total of 40 patients were finally included in the RCT. To include one patient into the RCT, 11.9 individuals needed to be screened. A total of 69% of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research (90%). CONCLUSIONS: Patients are willing to participate in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01264991, registered 21 December 2010.

Large increase in arthroscopic meniscus surgery in the middle-aged and older population in Denmark from 2000 to 2011.

BACKGROUND: Arthroscopic meniscal surgery is the most common orthopedic procedure, and the incidence has increased in Denmark over the last 10 years. Concomitantly, several randomized controlled trials have shown no benefit of arthroscopic procedures including arthroscopic partial meniscectomy in middle-aged and older individuals suffering from knee pain with or without knee osteoarthritis. We examined the annual incidence of meniscal procedures together with age, sex, and diagnosis for patients who underwent meniscal procedures in the period 2000-2011 in Denmark. METHODS: Data on age, sex, diagnosis, and surgical procedures were extracted from the Danish National Patient Register for the years 2000-2011, for all records containing meniscal surgery as a primary or secondary procedure. RESULTS: The overall annual incidence of meniscal procedures per 100,000 persons in Denmark doubled from 164 in 2000 to 312 in 2011 (i.e. 8,750 procedures to 17,368 procedures). A 2-fold increase was found for patients aged between 35 and 55, and a 3-fold increase was found for those older than 55. Middle-aged and older patients accounted for 75% of all 151,228 meniscal procedures carried out between 2000 and 2011. INTERPRETATION: The incidence of meniscal procedures performed in Denmark doubled from 2000 to 2011, with the largest increase in middle-aged and older patients. This increase contrasts with the mounting evidence showing no added benefit of arthroscopic partial meniscectomy over non-surgical treatments. Our observations illustrate the long delay in the dissemination, acceptance, and implementation of research evidence into the practice of arthroscopic surgery.

Arthroscopic partial meniscectomy in middle-aged patients with mild or no knee osteoarthritis: a protocol for a double-blind, randomized sham-controlled multi-centre trial.

BACKGROUND: Arthroscopic partial meniscectomy has been shown to be of no benefit to patients with concomitant knee osteoarthritis, but the optimal treatment of a degenerative meniscus tear in patients with mild or no knee osteoarthritis is unknown. This article describes the rationale and methodology of a randomized sham-controlled trial to assess the benefit of arthroscopic partial meniscectomy of a medial meniscus tear in patients with mild or no knee osteoarthritis. The objective of the study is to test whether the benefit from arthroscopic partial meniscectomy in patients with knee pain, medial meniscus lesion and mild/no knee osteoarthritis, is greater after arthroscopic partial meniscectomy than following sham surgery. METHODS: We will conduct a randomized controlled trial of treatment for degenerative meniscus tears in middle-aged patients (aged 35-55 years) with an MRI-verified medial meniscus lesion and mild or no knee radiographic osteoarthritis (grade 0-2 on the Kellgren & Lawrence scale). Patients will be randomized to receive either conventional arthroscopic partial meniscectomy or a sham surgery procedure. The primary outcome will be the KOOS5 derived from the 'Knee Injury and Osteoarthritis Outcome Score' at 2 years follow-up. Secondary outcomes at 2 years will include all five individual subscales of the KOOS, a global perceived effect score, the Short-Form-36 health status score, EQ-5D for economic appraisal and objective tests of muscle strength and physical function. Radiographic knee osteoarthritis will be evaluated at 5 years. DISCUSSION: Demonstration of no additional benefit from arthroscopic partial meniscectomy on pain and function should lead to a change in clinical care of patients with a degenerative meniscus tear. The results of this study will provide empirical evidence for the potential benefit/harm of arthroscopic partial meniscectomy compared to a masked sham-therapeutics intervention.