View clinical trials related to Osteoarthritis, Knee.
Filter by:This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to compare the safety and effectiveness of a single injection of Cingal® to a single injection of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of osteoarthritis of the knee.
Knee Osteoarthritis (OA) is a common degenerative knee condition of the knee which is treated symptomatically. Knee cartilage tissue has little regenerative ability With the developments in regenerative medicine, stem cells might also be used in knee OA. Recently, adipose tissue has been identified as means for autologous mesenchymal stem cells (aMAT) using non-enzymatic method. Lipogems® is FDA-approved closed-system and directly producing ready-to-use aMAT. Some observational studies showed its potential in knee chondropathy. With no clinical trial done as yet, the investigators will hereby study the comparative efficacy of corticosteroid (current practice) versus Lipogems® in patients with knee OA. The knee MRI changes, clinical and patient-based outcomes will compared between baseline and throughout till 6 months after treatment. This study aims to show the comparative efficacy of Lipogems® as compared to corticosteroid in knee OA patients and to demonstrate its cartilage regeneration potential, which will ultimately deter surgery.
The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.
This clinical trial is designed to determine safety and tolerability as well as the MTD of a single-dose 2ccPA and PK data in symptomatic knee OA.
A study to assess safety, tolerability and clinical effects of single and repeat dose intra-articular administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA).
This is a prospective cohort study comparing standard inpatient (overnight hospital stay) total knee arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be recruited. This study will compare patient satisfaction and costs from the perspectives of the Ministry of Health, the institution, society and the patient.
The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).
The management of knee osteoarthritis via a physical activity protocol for rehabilitation has convincing results. However, the effectiveness of these protocols could be improved with a connected instrumented knee brace with an exercise protocol adapted for the patient which is supervise by an online physiotherapist to check the progression during home-based rehabilitation.
Background: Duloxetine provides an analgesic effect of patients with OA. The mode of action of duloxetine is partly believed to act through modulating the descending inhibitory pain pathways from the brainstem towards the spinal cord thereby dampening pain by gating the afferent pain signals from the periphery during their passage to the brain. This study aims to investigate if the analgesic effect of duloxetine is due to modulation of pain mechanisms. Study Rationale: The present study will utilize a set of quantitative pain biomarkers developed to assess peripheral and central manifestations in OA and the influence of duloxetine on those manifestations. Treatment: Patients will be randomized to one of two treatment sequences: 1. Sequence 1: 20 mg duloxetine QD for 1 week, 40 mg Duloxetine QD for 1 week, 60 mg duloxetine QD for 10 weeks, 40 mg duloxetine QD for 1 week, 20 mg duloxetine QD for 1 week, followed by 14 weeks of corresponding placebo 2. Sequence 2: 14 weeks of placebo followed by 20 mg Duloxetine QD for 1 week, 40 mg duloxetine QD for 1 week, 60 mg duloxetine QD for 10 weeks, 40 mg duloxetine QD for 1 week and 20 mg duloxetine QD for 1 week. The two treatment periods of 14 weeks each are separated by a washout period of two weeks and include a two-week titration period. Primary Objective: To assess the effect of 60 mg daily maintenance dose administration of Duloxetine for 10 weeks compared with placebo on pain mechanisms. Sample Size Justification/Statistics: The sample size was calculated to 32 patients providing a power of 85% with a significant level of 0.05 to detect a group difference of 1 point in the change from baseline of the week 12 mean of 24-hour worst pain between duloxetine and placebo treatment. Patient Selection: Up to 40 patients with osteoarthritic knee pain will be enrolled in this study in order to complete 32 patients. Study sites: Mech-Sense Aalborg University Hospital, DK-9000 Aalborg, Denmark Study Assessments: As the primary objective of this study is the assessment of which pain mechanisms are modulated by administration of the study drug, the primary endpoints will be Experimental Mechanism Based Pain Measures (EPMs) including 1) Pressure Pain Thresholds (PPTs), Temporal Summation, Conditioned Pain Modulation (CPM) and Offset Analgesia. In addition, efficacy will be evaluated using 1) pain severity (worst daily pain and night pain), 2) Pittsburgh Sleep Quality Index (PSQI), 3) Brief Pain Inventory (BPI), 4) Investigator and Patient Global Assessment of Changes (IGIC and PGAC), 5) Western Ontario and MacMaster (WOMAC) OA physical function, 6) PainDetect, and 7) Central Sensitization Index (CSI). Safety: Discontinuation rates and Treatment Emergent Adverse Events (TEAEs). Key Inclusion/Exclusion Criteria: Males or females between 40 and 75 years of age, who are postmenopausal or using allowed contraception methods, and have a Body Mass Index (BMI) between 20-35 kg/m2 inclusive Patient with unilateral or bilateral OA of knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence with pain severity equal to or higher than 5 on a Visual Analogue Scale (VAS) assessed as the worst pain within the last 24 hours.
The goal of the proposed research is to compare the ERIPTO protocol for post-traumatic osteoarthritis of the knee with that of bone marrow aspirate concentrate (BMAC) only. The investigators will also conduct a statistical regression analysis looking into factors such as time frame from initial injury, the type of injury, gender, and age when injury first occurred. The investigators plan on evaluating clinically and radiographically the effects of the ERIPTO Protocol. There will be two arms of this study. The first arm will be our protocol arm and the second arm will be our BMAC treatment only arm. The investigators plan on collecting objective data on osteoarthritis (OA) severity by taking plain films and assessing the Kellgren-Lawrence (KL) grading scheme in assessing OA severity. The investigators will also administer MRI evaluations for cartilage and meniscal growth prior to treatment and after 1 year. The investigators also plan on collecting subjective symptom scores in the form of knee injury and osteoarthritis outcomes scores (KOOS), visual analog scores (VAS), and international knee documentation criteria (IKDC) score for OA severity. The investigators plan to track changes in both subjective and objective measures of knee OA in our patients through the course of one year.