BackgroundArthroscopic 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.MethodsData 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.ResultsThe 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.InterpretationThe 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.

ObjectiveCompare arthroscopic partial meniscectomy to a true sham intervention.MethodsSham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35–55 years with persistent knee pain and an MRI-confirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, high-energy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5).ResultsForty-four patients (of the estimated 72) underwent randomisation; 22 in each group. Sixteen participants (36%) were non-blinded and eight participants (36%) from the sham group crossed over to the surgery group prior to the 2-year follow-up. At 2 years, both groups reported clinically relevant improvements (surgery 21.8, skin incisions only 13.6), the mean difference between groups was 8.2 in favour of surgery, which is slightly less than the cut-off of 10 prespecified to represent a clinically relevant difference; judged by the 95% CI (−3.4 to 19.8), a possibility of clinically relevant difference could not be excluded. In total, nine participants experienced 11 adverse events; six in the surgery group and three in the skin-incisions-only group.ConclusionWe found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years, with the statistical uncertainty of the between-group difference including what could be considered clinically relevant. Because of the study being underpowered, nearly half in the sham group being non-blinded and one-third crossing over to surgery, the results cannot be generalised to the greater patient population.Trial registration numberNCT01264991.

BackgroundRandomized 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.MethodsData 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.ResultsA 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%).ConclusionsPatients 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 registrationClinicalTrials.gov NCT01264991, registered 21 December 2010.

BackgroundArthroscopic 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.MethodsWe 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.DiscussionDemonstration 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.Trial registrationNCT01264991

ObjectivesA recent study reported a large increase in the number of meniscal procedures from 2000 to 2011 in Denmark. We examined the nation-wide distribution of meniscal procedures performed in the private and public sector in Denmark since different incentives may be present and the use of these procedures may differ from region to region.SettingWe included data on all patients who underwent an arthroscopic meniscal procedure performed in the public or private sector in Denmark.ParticipantsData were retrieved from the Danish National Patient Register on patients who underwent arthroscopic meniscus surgery as a primary or secondary procedure in the years 2000 to 2011. Hospital identification codes enabled linkage of performed procedures to specific hospitals.Primary and secondary outcome measuresYearly incidence of meniscal procedures per 100 000 inhabitants was calculated with 95% CIs for public and private procedures for each region.ResultsIncidence of meniscal procedures increased at private and at public hospitals. The private sector accounted for the largest relative and absolute increase, rising from an incidence of 1 in 2000 to 98 in 2011. In 2011, the incidence of meniscal procedures was three times higher in the Capital Region than in Region Zealand.ConclusionsOur study identified a large increase in the use of meniscal procedures in the public and private sector in Denmark. The increase was particularly conspicuous in the private sector as its proportion of procedures performed increased from 1% to 32%. Substantial regional differences were present in the incidence and trend over time of meniscal procedures.

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.

IntroductionUndisplaced femoral neck fractures (FNFs) are usually treated by internal fixation (IF) but two randomised controlled trials (RCTs) have demonstrated advantages of treatment with arthroplasty. The complication rate was lowered but there were no clinically improved patient-reported outcome measures (PROM), which could be due to underpowering or choice of selected PROM as the studies do appear to report a better functional outcome. We will conduct an RCT comparing IF with arthroplasties in patients aged over 65 years with an undisplaced FNF.Methods and analysisAll hospitals in Denmark treating patients with hip fracture can provide patients for this study; therefore, the study can be considered a national RCT. Patients over 65 years old with an undisplaced FNF will be screened for eligibility and patients will only be excluded if they are unable to understand the study information (due to dementia or language), if they have a posterior tilt >20°, a pathological fracture or they cannot walk. Participants will be electronically randomised (in alternating blocks of 4 or 6) into either IF or arthroplasty. Postoperative care will follow the department standards.Primary and secondary outcomes and measuring points have been established in collaboration with patients with hip fracture by focus group interviews. The primary outcome measure is the New Mobility Score assessed after 1 year. Secondary outcomes are the Oxford Hip Score, EuroQol 5 domain (EQ-5D-5L), degree of posterior tilt, pain Verbal Rating Scale, reoperation and mortality.Ethics and disseminationThe study is approved by the Danish Data Protection Agency (19/7429) and the scientific ethics committee (S-20180036). All participants will sign an informed consent before entering the trial. Because this is a national trial, all relevant healthcare professionals in Denmark will automatically receive the trial results that will be published in international peer-reviewed journals.Trial registration numberClinicalTrials.gov Registry (NCT04075461).

Background Knee fractures may lead to post-traumatic knee osteoarthritis and subsequent TKA in some patients. However, absolute risk estimates and risk factors for TKA in patients with knee fractures compared with those of the general population remain largely unknown. Such knowledge would help establish the treatment burden and direct patient counseling after a knee fracture is sustained. Questions/purposes (1) What is the short-term risk of TKA after knee fracture? (2) What is the long-term risk of TKA after knee fracture? (3) What are the risk factors for TKA in patients with knee fractures? Methods A nationwide 20-year, matched-case comparison cohort study of prospectively collected data from the Danish National Patient Registry included all patients at least 15 years old with International Classification of Diseases, 10th revision codes DS724, DS820, or DS821 (knee fractures) on the date their knee fracture was registered. Each patient with a knee fracture was matched (by sex and age) to five people without knee fractures from the general Danish population on the date the knee fracture patient’s knee fracture was registered (population controls). Patients with knee fractures and people in the population control group were followed from the date the knee fracture patient’s knee fracture was registered to the date of TKA, amputation, knee fusion, emigration, death, or end of follow-up in April 2018. TKA risks for patients with knee fractures versus those for population controls and TKA risk factors in patients with knee fractures were estimated using hazard ratios (HRs) with 95% CIs. A total of 48,791 patients with knee fractures (median age 58 years [interquartile range 41-73]; 58% were female) were matched to 263,593 people in the population control group. Results The HR for TKA in patients with knee fractures compared with population controls was 3.74 (95% CI 3.44 to 4.07; p < 0.01) in the first 3 years after knee fracture. Among knee fracture patients, the risk of undergoing TKA was 2% (967 of 48,791) compared with 0.5% (1280 of 263,593) of people in the population control group. After the first 3 years, the HR was 1.59 (95% CI 1.46 to 1.71) and the number of patients with knee fractures with TKA events divided by the number at risk was 2% (849 of 36,272), compared with 1% (2395 of 180,418) of population controls. During the 20-year study period, 4% of patients with knee fractures underwent TKA compared with 1% of population controls. Risk factors for TKA in patients with knee fractures were: primary knee osteoarthritis (OA) versus no primary knee OA (HR 9.57 [95% CI 5.39 to 16.98]), surgical treatment with external fixation versus open reduction and internal fixation and reduction only (HR 1.92 [95 % CI 1.01 to 3.66]), proximal tibia fracture versus patellar fracture (HR 1.75 [95 % CI 1.30 to 2.36]), and distal femur fracture versus patellar fracture (HR 1.68 [95 % CI 1.08 to 2.64]). Surgical treatment of knee fractures was also a risk factor for TKA. The HRs for TKA in patients with knee fractures who were surgically treated versus those who were treated non-surgically were 2.05 (95% CI 1.83 to 2.30) in the first 5 years after knee fracture and 1.19 (95% CI 1.01 to 1.41) after 5 years. Conclusions Patients with knee fractures have a 3.7 times greater risk of TKA in the first 3 years after knee fracture, and the risk remains 1.6 times greater after 3 years and throughout their lifetimes. Primary knee OA, surgical treatment of knee fractures, external fixation, proximal tibia fractures, and distal femur fractures are TKA risk factors. These risk estimates and risk factors highlight the treatment burden of knee fractures, building a foundation for future studies to further counsel patients on their risk of undergoing TKA based on patient-, fracture-, and treatment-specific factors. Level of Evidence Level III, prognostic study.