Efficacy and Safety of Stempeucel in Osteoarthritis of the Knee: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study.

BACKGROUND: Osteoarthritis is a chronic, progressive, and degenerative condition with limited therapy options. Recently, biologic therapies have been an evolving option for the management of osteoarthritis. PURPOSE: To assess whether allogenic mesenchymal stromal cells (MSCs) have the potential to improve functional parameters and induce cartilage regeneration in patients with osteoarthritis. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 146 patients with grade 2 and 3 osteoarthritis were randomized to either an MSC group or placebo group with a ratio of 1:1. There were 73 patients per group who received either a single intra-articular injection of bone marrow-derived MSCs (BMMSCs; 25 million cells) or placebo, followed by 20 mg per 2 mL of hyaluronic acid under ultrasound guidance. The primary endpoint was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. The secondary endpoints were WOMAC subscores for pain, stiffness, and physical function; the visual analog scale score for pain; and magnetic resonance imaging findings using T2 mapping and cartilage volume. RESULTS: Overall, 65 patients from the BMMSC group and 68 patients from the placebo group completed 12-month follow-up. The BMMSC group showed significant improvements in the WOMAC total score compared with the placebo group at 6 and 12 months (percentage change: -23.64% [95% CI, -32.88 to -14.40] at 6 months and -45.60% [95% CI, -55.97 to -35.23] at 12 months P < .001; percentage change, -44.3%). BMMSCs significantly improved WOMAC pain, stiffness, and physical function subscores as well as visual analog scale scores at 6 and 12 months (P < .001). T2 mapping showed that there was no worsening of deep cartilage in the medial femorotibial compartment of the knee in the BMMSC group at 12-month follow-up, whereas in the placebo group, there was significant and gradual worsening of cartilage (P < .001). Cartilage volume did not change significantly in the BMMSC group. There were 5 adverse events that were possibly/probably related to the study drug and consisted of injection-site swelling and pain, which improved within a few days. CONCLUSION: In this small randomized trial, BMMSCs proved to be safe and effective for the treatment of grade 2 and 3 osteoarthritis. The intervention was simple and easy to administer, provided sustained relief of pain and stiffness, improved physical function, and prevented worsening of cartilage quality for ≥12 months. REGISTRATION: CTRI/2018/09/015785 (National Institutes of Health and Clinical Trials Registry-India).

Incidence and factors influencing tourniquet pain.

PURPOSE: The use of tourniquet in orthopedic surgery facilitates operation by establishing a bloodless surgical field. However, many complications following the use of tourniquets have been reported. Tourniquet pain is the most common complication. This study aimed to find the actual incidence of pain associated with tourniquet use in orthopedic surgery and the various factors. METHODS: It is a prospective observational study conducted on 132 consecutive cases. Patients aged 18-70 years with musculoskeletal problems of the forearm and leg requiring surgery were included in the study. Patients with open injuries or contraindications such as diabetes mellitus, compromised circulatory states, neurological deficit, compartment syndrome and unable to give informed consent were excluded. The parameters assessed included duration of tourniquet use, tourniquet pressure, type of anesthesia, any interval release of the tourniquet and reapplication after a reperfusion period, whether upper or lower limb surgery, severity of tourniquet pain, timing of tourniquet release and complications. Chi-square and non-parametric Mann-Whitney U test were used for data analysis. RESULTS: In upper limb surgeries, if duration of surgery was less than 60 min, 14 (51.8%) cases experienced tourniquet pain and 13 (48.1%) had no pain, and if duration of surgery was more than 60 min, 24 (60.0%) had pain and 16 (40.0%) experienced no pain. In lower limb surgeries if duration of surgery was less than 60 min, 2 (7.7%) experienced pain and 24 (92.3%) had no pain, and if duration of surgery was more than 60 min, 14 (35.8%) experienced pain and 25 (64.8%) had no pain. Degree of tourniquet pain increases with the duration of surgery. Statistically, there was significant association between tourniquet inflation time and tourniquet pain in both upper and lower limbs (p = 0.034 and 0.024, respectively) CONCLUSION: Incidence of tourniquet pain was in direct proportion to the duration of tourniquet use and was higher in cases with regional anesthesia. Other risk factors assessed including tourniquet pressure, upper or lower limb surgery, tourniquet release time and interval had no significant contribution to the incidence or severity of tourniquet pain.

Cross-sectional assessment of cardiovascular risk factors in patients with knee osteoarthritis.

Background: Osteoarthritis (OA) and cardiovascular disease (CVD) are prevalent in India. However, there is dearth of literature among Indians studying the relationship between the two. This study was carried out to assess various cardiovascular (CV) risk factors in patients with knee OA with an objective to investigate their association, screening and management.  Methods: In total, 225 patients were included in this cross-sectional study. Participants were diagnosed with knee OA on the basis of the Kellgren and Lawrence (K-L) classification of their radiograph. Participants were also assessed for CV risk factors; age, body mass index, systolic blood pressure, diabetes mellitus, total cholesterol, high-density lipoprotein, smoking. Joint British Society QRisk3 calculator (JBS3) a comprehensive risk score calculator as well as a screening tool, which produces three more variables, namely 10-years risk of developing CVD, physiological heart age and life expectancy, was used. Chi Square, Fishers exact test and one-way ANOVA tests were used to compare the categorical and quantitative variables, respectively.. Multiple regression analysis was done to adjust the multiple con-founders and determine their significance. Results: Patients with severe knee OA had a statistically significantly higher prevalence of CV risk factors (p<0.05). Grade 4 knee OA patients were found to have a mean JBS3 risk of 38%, heart age of 82 years and life expectancy of 77 years as compared to grade 2 patients who had a mean JBS3 risk of 11%, heart age of 63 years and life expectancy of 82 years.  Conclusions: Our study concluded that there is a strong relation between knee OA and CVD, with CV risk score being positively correlated to the severity of OA.

A Case Report of Isolated Cysticercosis of Biceps Muscle.

INTRODUCTION: Cysticercosis is more commonly seen in developing countries like India caused by larval stage of Taenia solium. Neurocysticercosis is more commonly seen than isolated muscle involvement. There are very few sporadic cases of isolated biceps muscle involvement, but most of them are managed medically. We are reporting an isolated case of cysticercosis of biceps muscle managed surgically. CASE REPORT: A 32-year-old male, security personnel by occupation, comes with complaints of painful swelling of the right arm for past 1 week. There was no trauma to the limb and no similar swellings elsewhere in the body. On examination, there was an anteromedial tender swelling of mid-third of arm. X-ray was normal with soft tissue shadow on the anterior aspect. Ultrasound showed cystic lesion with central hyperechoic lesion. Magnetic resonance imaging of arm showed 7.7 mm × 4.8 mm lesion in anteromedial aspect of arm with surrounding edema s/o granuloma. The patient underwent excision of the cyst and biopsy was suggestive of cysticercosis and surrounding granuloma. CONCLUSION: Isolated cysticercosis of muscle is very rare, but when it is symptomatic and hindering in daily activities, surgical excision can be done for faster relief and early return to normal day-to-day activities.

Lasègue's Sign.

Lasègue's sign is an interesting and important clinical sign in medicine for the last 150 years. The Lasègue test is commonly used in the physical examination of patients with low back pain. It is a test for lower lumbosacral nerve root irritation for example, due to disc prolapse. It is evident that the method of performance of this diagnostic sign varies with the physician. This article reviews the historical background and method of eliciting the sign.

Accuracy of Needle Placement into the Intra-Articular Space of the Knee in Osteoarthritis Patients for Viscosupplementation.

INTRODUCTION: Knee osteoarthritis is characterized by inflammation in the intra-articular space or synovial membrane, breakdown of articular cartilage, and sclerosis of the subchondral bone. Intra-articular injections of Sodium hyaluronate which have viscoelastic and protective effect on articular cartilage and restores normal articular homeostasis. The efficacy of these injections is diminished when they are placed inadvertently outside the joint. For the maximum benefit, injection of hyaluronic acid derivatives needs to be placed accurately into the knee joint. AIM: The study was performed to know the correct placement of needle inside the knee joint prior to Viscosupplementation by fluoroscopy using a contrast material. MATERIALS AND METHODS: The accurate placement of needle was evaluated in a prospective series of 94 consecutive injections in patients without clinical knee effusion. All the injections were performed by single orthopaedic surgeon using a 5 cm 21-gauge needle through anterolateral, and lateral midpatellar portals. The needle placement in the knee joint was confirmed with fluoroscopy using the contrast material. RESULTS: The accuracy rates through Lateral midpatellar and Anterolateral portals were lower than expected rate (100%). A total of 43 out of 47 injections were intra-articular, indicating accuracy of 91.5% through lateral midpatellar portal, 41 out of 47 injections were intra-articular through anterolateral portal with accuracy of 87.4%. CONCLUSION: Study showed that the accuracy of needle placement was higher through Lateral midpatellar than the Anterolateral portal.