The validity of a non-fluoroscopic fixed-flexion radiographic acquisition and analysis protocol for measurement of joint space width (JSW) in knee osteoarthritis is determined. A cross-sectional study of 165 patients with documented knee osteoarthritis participating in a multicenter, prospective study of chondroprotective agents was performed. All patients had posteroanterior, weight-bearing, fixed-flexion radiography with 10 degrees caudal beam angulation. A specially designed frame (SynaFlexer) was used to standardize the positioning. Minimum medial and lateral JSW were measured manually and twice by an automated analysis system to determine inter-technique and intra-reader concordance and reliability. A random subsample of 30 patients had repeat knee radiographs 2 weeks apart to estimate short-term reproducibility using automated analysis. Concordance between manual and automated medial JSW measurements was high (ICC=0.90); lateral compartment measurements showed somewhat less concordance (ICC=0.72). There was excellent concordance between repeated automated JSW measurements performed 6 months apart for the medial (ICC=0.94) and lateral (ICC=0.86) compartments. Short-term reproducibility for the subsample of 30 cases with repeat acquisitions demonstrated an average SD of 0.14 mm for medial JSW (CV=4.3%) and 0.23 mm for lateral JSW (CV=4.0%). Fixed-flexion radiography of the knee using a positioning device provides consistent, reliable and reproducible measurement of minimum JSW in knee osteoarthritis without the need for concurrent fluoroscopic guidance.
We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and efficacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07–1.37 (all P < 0.001). Compared to saline controls, SMDs with IAHA ranged from 0.38–0.43 for knee pain and 0.32–0.34 for knee function (all P < 0.001). There were no statistically significant differences between IAHA and saline controls for any safety outcome, including serious adverse events (SAEs) (P = 0.12), treatment-related SAEs (P = 1.0), study withdrawal (P = 1.0), and AE-related study withdrawal (P = 0.46). We conclude that intra-articular injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis.
Surgery is indicated for symptomatic knee osteoarthritis (OA) when conservative measures are unsuccessful. High tibial osteotomy (HTO), unicompartmental knee arthroplasty (UKA), and total knee arthroplasty (TKA) are surgical options intended to relieve knee OA pain and dysfunction. The choice of surgical intervention is dependent on several factors such as disease location, patient age, comorbidities, and activity levels. Regardless of surgical treatment, complications such as infection, loosening or lysis, periprosthetic fracture, and postoperative pain are known risks and are indications for revision surgery. The clinical and economic implications for revision surgery are underappreciated. Over 55,000 revision surgeries were performed in 2010 in the US, with 48% of these revisions in patients under 65 years. Total costs associated with each revision TKA surgery have been estimated to be in excess of $49,000. The current annual economic burden of revision knee OA surgery is $2.7 billion for hospital charges alone. By 2030, assuming a 5-fold increase in the number of revision procedures, this economic burden will exceed $13 billion annually. It is appealing to envision a therapy that could delay or obviate the need for arthroplasty. From an actuarial standpoint, this would have the theoretical downstream effect of substantially reducing the number of revision procedures. Although no known therapies currently meet these criteria, such a breakthrough would have a tremendous impact in lessening the clinical and economic burden of knee OA revision surgery.
Knee osteoarthritis (OA) has a significant negative impact on health-related quality of life (HRQoL). Identification of therapies that improve HRQoL in patients with knee OA may mitigate the clinical, economic, and social burden of this disease. The purpose of this commentary is to report the impact of knee OA on HRQoL, describe the change in HRQoL attributable to common knee OA interventions, and summarize findings from clinical trials of a promising therapy. Nonsurgical therapies do not reliably modify HRQoL in knee OA patients given their general inability to alleviate physical manifestations of OA. Surgical knee OA interventions generally result in good to excellent patient outcomes. However, there are significant barriers to considering surgery, which limits clinical utility. Therapies that most effectively control OA-related pain with a low risk: benefit ratio will likely have the greatest benefit on HRQoL with greater rates of patient adoption. Initial clinical trial findings suggest that less invasive joint unloading implants hold promise in bridging the therapeutic gap between nonsurgical and surgical treatments for the knee OA patient.
BackgroundWe compared the healing response of tibial delayed unions between subjects treated with low-intensity pulsed ultrasound (LIPUS) (n = 51) and subjects treated with a sham device (n = 50). Fracture age was ≥ 4 months in all cases. Study personnel and participants were blinded to random treatment assignment throughout the study.MethodsThis multi-center randomized sham-controlled trial was undertaken at six hospitals in Germany. Adult patients who had sustained a tibial shaft fracture that subsequently showed inadequate progress toward healing (i.e., delayed union) were enrolled and randomized to receive either LIPUS (Exogen 2000/2000+, Smith & Nephew GmbH, Schenefeld, Germany) or an identical nonoperative sham device. The daily treatment duration was 20 minutes, for a period of 16 weeks. Subjects randomly assigned to active treatment had the ultrasound pressure wave signal set at the following parameters: 1.5 MHz frequency, 1 kHz repetition rate, 200 μs pulse duration, 30 mW/cm2 spatial intensity. Progress toward healing was estimated from changes in bone mineral density (BMD) and gap area as determined from computed tomography scans. Intention-to-treat analysis was conducted using a multiple imputation methodology.ResultsBased on log-transformed data, mean improvement in BMD was 1.34 (90% confidence interval (CI) 1.14 to 1.57) times greater for LIPUS-treated subjects compared to sham (p = 0.002). A mean reduction in bone gap area also favored LIPUS treatment (p = 0.014).ConclusionsThese findings demonstrate significantly greater progress toward bone healing after LIPUS treatment compared to no LIPUS treatment in subjects with established delayed unions of the tibia.
Conservative management of medial compartment knee osteoarthritis (OA) is a misleading term used to describe the application of medical, orthotic, and/or rehabilitative therapies exclusive of surgical interventions. The implication of this nomenclature is that these therapies offer satisfactory symptom relief, alter disease progression, and have limited side effects. Unfortunately, conservative therapeutic options possesses few, if any, characteristics of an ideal treatment, namely one that significantly alleviates pain, improves knee function, and reduces medial compartmental loading without adverse side effects. As uncompensated mechanical loading is a primary culprit in the development and progression of knee OA, we propose that the therapeutic perspective of conservative treatment should shift from pharmacological treatments, which have no influence on joint loading, minimal potential to alter joint function, substantial associated risks, and significant financial costs, towards minimally invasive load absorbing therapeutic interventions. A safe and effective minimally invasive medical device specifically engineered for symptomatic relief of medial knee OA by limiting joint contact forces has the potential to reduce the clinical and economic knee OA burden. This review characterizes the current standard of care recommendations for conservative management of medial compartment knee OA with respect to treatment efficacy, risk profile, and economic burden.
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