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Osteoarthritis, Knee clinical trials

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NCT ID: NCT01237405 Completed - Knee Osteoarthritis Clinical Trials

A Study of FolateScan in Patients With Knee Osteoarthritis

Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate 99mTc - EC20 imaging (FolateScan), a Nuclear Medicine imaging technology that enables localization of activated macrophages in the joints of participants with knee osteoarthritis (OA). Twenty five participants with symptomatic unilateral or bilateral knee OA will undergo a one-time evaluation of the knee as follows: knee radiography, FolateScan of the knees and whole body, musculoskeletal exam, questionnaires, sampling of blood, urine and synovial fluid for analysis of inflammatory markers. Data analysis will be cross-sectional and include a comparison of the location and intensity of EC20 uptake with the following: radiographic knee OA severity, clinical measures of disease severity, cytokine expression, and synovial fluid cell count.

NCT ID: NCT01227694 Completed - Clinical trials for Osteoarthritis, Knee

Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires. MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month. The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.

NCT ID: NCT01226615 Unknown status - Knee Osteoarthritis Clinical Trials

Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)

Start date: October 2010
Phase: Phase 4
Study type: Interventional

The main purposes of this study are: - to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis. - to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.

NCT ID: NCT01225133 Completed - Osteoarthritis Clinical Trials

Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.

CARAKA
Start date: October 2010
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and treatment compared to conventional standard care in patients with OA of the knee.

NCT ID: NCT01224522 Terminated - Clinical trials for Osteoarthritis of the Knee

Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks

Visionaire
Start date: March 2011
Phase: Phase 3
Study type: Interventional

- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION - Short Title: Visionaire Alignment - Methodology: Monocentric, Single Blinded, Randomized Controlled Trial - Study Duration: November 2010 to July 2014 - Study Centres: Leicester General Hospital, United Kingdom (UK)

NCT ID: NCT01221441 Completed - Clinical trials for Osteoarthritis, Knee

Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

NCT ID: NCT01210742 Recruiting - Knee Osteoarthritis Clinical Trials

The Efficacy of Viscosupplementation for Early Knee Osteoarthritis

EVOKE
Start date: May 2011
Phase: N/A
Study type: Interventional

Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the research into OA, to date, concentrates on predisposition, genetic and cellular aspects and the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early OA have great difficulty in recommending an appropriate and efficacious intervention. The first line of treatment for patients with early OA is exercise, self-management and weight loss. These tools are suggested to minimize the need for higher risk treatments such as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To date, the ideal patient for viscosupplementation has yet to be defined. It is not known whether incorporation of viscosupplementation into the overall clinical management will have beneficial influence for patients with early OA of the knee. This study will generate rigorous pilot data to assess the need and inform a larger randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study will be a single blind randomised RCT. 60 patients with documented early OA will be randomised into one of two groups; Group V will undergo "one shot" viscosupplementation using Synvisc One in addition to routine physiotherapy management for knee OA. Group No V (control) will have no viscosupplementation but will undergo similar routine management including physiotherapy management for knee OA. Outcome measures will include walking pain (The Western Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC score, Oxford Knee Score (OKS), American Knee Society score (AKS), complications, activity level and patient satisfaction. Health economics will also be evaluated. Measurements will be recorded pre-intervention and at six months following treatment. The risks associated with viscosupplementation are minimal. Considering the limited resources currently available in health care, if the latter is shown to have higher effectiveness than physiotherapy alone, in addition to patient benefit, there will be important health economic implications.

NCT ID: NCT01210183 Completed - Knee Osteoarthritis Clinical Trials

Biological Response of Stage IV Knee Osteoarthritis to Serial 12.5% Dextrose

Start date: July 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Dextrose injection in end-stage knee arthritis will cause growth of cartilage cells in a particular area of complete cartilage loss. Dextrose concentration will be 12.5%. Cartilage status will be monitored by pre and post treatment arthroscopy views with specialized (methylene blue) staining for cartilage.

NCT ID: NCT01209364 Completed - Knee Osteoarthritis Clinical Trials

Durolane Versus Methylprednisolone in Knee Osteoarthritis

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

NCT ID: NCT01207973 Terminated - Osteoarthritis Clinical Trials

Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee

Start date: September 2010
Phase: Phase 1
Study type: Interventional

The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.