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Osteoarthritis, Knee clinical trials

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NCT ID: NCT03513094 Completed - Clinical trials for Osteoarthritis, Knee

Effect of TA Contraction on Gait in Patients With Knee OA

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effects of core activation on knee joint loading during ambulation in patients with knee osteoarthritis (OA). This study aims to investigate the effects of transversus abdominis (TA) activation during simultaneous kinetic analysis of time to initial peak ground reaction force (T1) at the heel in the sagittal plane. The objective of this study is to determine whether patients with knee OA demonstrate changes in T1 during comfortable gait speeds when actively contracting the TA muscle. In addition, this study will serve as a pilot study in order to perform a post-hoc power analysis for future study on the effects of the independent variable (TA contraction/changes in core stability) on the dependent variable (T1). Null hypothesis: There will be no change in T1 in patients with knee OA during gait while contracting their TA. Alternate hypothesis: There will be a decrease in T1 in patients with knee OA during gait while contracting their TA.

NCT ID: NCT03513016 Completed - Clinical trials for Osteoarthritis, Knee

A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee

Start date: May 16, 2018
Phase: Phase 1
Study type: Interventional

A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.

NCT ID: NCT03509025 Completed - Knee Osteoarthritis Clinical Trials

Follow-up Study for Participants Jointstem Clinical Trial

Start date: February 8, 2017
Phase: Phase 2
Study type: Interventional

This study is a long term follow-up study to investigate the safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.

NCT ID: NCT03498833 Completed - Clinical trials for Osteo Arthritis Knee

Comprehensive Knee Osteoarthritis Index (CKOAI): Scale Development, Validation and Reliability Testing

CKOAI
Start date: April 17, 2018
Phase: N/A
Study type: Interventional

Background: Symptoms, balance, mobility, activities of daily life (ADL) and quality of life (QoL) are to be considered in rehabilitation of the individuals with knee osteoarthritis (IKOA). There are several scales to evaluate subjective perceptions and individual components in patients with osteoarthritis (OA). Till date, no scale is available to measure the combined balance, mobility, ADL and QoL in PKOA. Objectives: The objectives of the study are to develop a combined measure of symptoms, balance, mobility, ADL and QoL in PKOA, as comprehensive knee osteoarthritis index (CKOAI) and to validate the scale for its content, reliability and minimum detectable change (MDC) Methods: The study consists of a three stages. First stage is the scale (CKOI) item development and validation. This includes domain and item generating through systematic literature search to extract items related symptoms, balance, mobility, ADL and QoL in IKOA based on the International Classification of Functioning, Disability and Health (ICF) and through structured interviews. During scale validation, an expert panel will review the generated domains and items by Delphi Method, which will undergo revision and pilot testing. Based on the responsiveness of pilot testing will be revised finally. Second stage is to test re-test reliability. The third stage is to report the standard error of measurement (SEM) and minimal detectable change (MDC). Data analysis: All the domains and items in CKOAI will undergo reliability and criterion-related validity. Minimum 50 IKOA will be evaluated with the scale on two occasions within two weeks to establish test retest reliability. Cronbach's alpha for internal consistency and Intra class correlation coefficient for test retest reliability will be used to determine the degree of consistency of items in the scale. MDC will be calculated using the formulae, SEM = SD x √ (1-reliability) and MDC95 = √2 x (1.9) x (SEM). Significant level will be set at p value less than 0.05 (p < 0.05) to minimize the type-I error.

NCT ID: NCT03492320 Completed - Clinical trials for Total Knee Replacement

Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty

TKA HRQoL
Start date: March 1, 2013
Phase:
Study type: Observational

To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR

NCT ID: NCT03491904 Completed - Clinical trials for Osteoarthritis, Knee

To Assess the Patients' Ability to Self-Administer Fasinumab

FACT DEVICE
Start date: January 23, 2019
Phase: Phase 1
Study type: Interventional

The primary objective is to demonstrate that the auto-injector(AI) is suitable to be used to administer fasinumab at home by patients or their caregivers, as measured by collecting 12 weeks of actual-use data on the technical performance of the device. The secondary objectives of the study are: - To evaluate the successful injection of fasinumab by patients or their caregivers using the AI in an unsupervised setting - To evaluate patient/caregiver satisfaction with the AI for fasinumab injection in an unsupervised setting - To evaluate exposure in serum for fasinumab administered by patients or their caregivers using an AI in an unsupervised setting, or fasinumab administered by study staff using a PFS that has been used in the phase 3 program - To characterize the safety, tolerability, and immunogenicity of fasinumab administered by patients or their caregivers using an AI in an unsupervised setting, or fasinumab administered by study staff using a PFS that has been used in the phase 3 program

NCT ID: NCT03491397 Completed - Knee Osteoarthritis Clinical Trials

Genicular Artery Embolization for the Treatment of Knee Osteoarthritis

GAE-OA
Start date: February 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

NCT ID: NCT03485157 Completed - Knee Osteoarthritis Clinical Trials

Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

Start date: March 27, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

NCT ID: NCT03484910 Completed - Exercise Therapy Clinical Trials

Biofeedback With Cycling Exercise in OA Knee Patients

Start date: March 2, 2018
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) is one of the most common joint diseases causing pain, muscle weakness and disability in older population. Quadriceps muscle weakness is one of the recognized risk factors for the development and the progression of the disease. Increasing the muscle strength could actually bring many benefits to the knee OA patients. The purposes of this study are 1) to investigate the effects of combining the EMG biofeedback technique into a stationary cycling exercise on the activities of vastus medialis (VM) in people with medial compartment knee OA; 2) To investigate the efficiency of a 6-week cycling exercise program on improving of quadriceps muscle strength and endurance, physical functions and pain in these patients and compare between the conditions of with or without EMG biofeedback; 3) To determine the relationships between the muscle activities and the kinematics of the knee joint during this cycling exercise program; and therefore to find the mechanism of the improvement on muscle activities in the intervention of cycling combining EMG biofeedback. In this study, we will enroll the knee OA patients from our hospital, and they will be randomly assigned either to the control group, who will cycle without biofeedback, or the biofeedback group, who will cycle with a real-time visual EMG biofeedback, during the six-week training program. The exercise program consisted of a 5-minute warm-up with low-resistance cycling, 30-minute moderate-resistance cycling exercise, and 5-minute cool down session. . The knee adduction angle, quadriceps strength and endurance, KOOS Chinese version, VAS scale will also be measured at baseline and after six weeks of intervention. Mixed-model repeated measure analysis of variance (ANOVA) will be used to determine if there are any differences in the kinematic, myoelectric, muscle strength and endurance. It is hoped that the results of this study could provide information regarding the proper and efficient training strategy for the OA knee patients, and deliver the concepts of proper exercise technique to enhance health in the community.

NCT ID: NCT03483090 Completed - Clinical trials for Osteoarthritis, Knee

Investigating the Effect of Deep Sea Krill Oil Supplementation in Osteoarthritis of the Knee

Start date: February 27, 2018
Phase: Phase 2
Study type: Interventional

To evaluate the effectiveness of 4 g Swisse High Strength Deep Sea Krill Oil (Superba BOOST) daily on pain reduction in adults with mild to moderate osteoarthritis of the knee compared to placebo over a 6 month period. This is a multicentre, randomised, double-blind, placebo-controlled parallel-arm study. Applicants will be eligible to participate if they have mild to moderate OA of the knee. Diagnosis of OA of the knee will be made according to clinical diagnosis, using the American College of Rheumatology (ACR) Criteria for the classification of Idiopathic OA of the Knee and the Kellgren-Lawrence grading scale. In addition, eligible applicants will have been experiencing knee pain on at least 4 days per week, for at least 3 months and they will report knee pain between 4 and 8 cm (inclusive) on a visual analogue scale (VAS) for the 7 days prior to Day 1 of the trial (Baseline). Severity of OA of the knee will be assessed based on X-ray performed at the Screening Visit using the Kellgren-Lawrence (KL) radiographic criteria, and participants with severe radiographic knee OA (KL joint space narrowing (JSN) above grade 3) will be excluded. Applicants will attend a screening visit following pre-screening assessments to assess their general health and eligibility for inclusion into the study. On Day 1 eligible participants will be randomly allocated to receive one of two study treatments. Participants will take the assigned treatments daily for six months. Participants will return to the clinic at 3 months and 6 months for study assessments. Participants will complete an online survey at 1, 2, 4 and 5 months to assess protocol compliance, adverse events and use of concomitant medications. Any queries from the survey will be followed up by phone call. A final participant online survey and phone call (if needed) will be conducted 28 days after the 6 month visit for a final safety assessment.