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193 active trials for Osteoarthritis

DSJ-2016-07 ATTUNE® Cementless CR RP Japan

The primary objective is to investigate the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score) in the Japanese patient population.

Start: June 2017

Geniculate Artery Embolization for Treatment of Osteoarthritis

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.

Start: December 2020

Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee

This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford (Warsaw, IN) mobile bearing unicompartmental knee arthroplasty. Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis from the investigating gait lab. The investigators hypothesize that post-operative UKA patients will display higher clinical scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The investigators further hypothesize that the biomechanics data will assist in the understanding of the outcome score differential both pre- and post-operatively in both groups, as well as between-groups. Total follow up period will be two years.

Start: February 2016

Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty

The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient's leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA)

Start: February 2021

Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty

The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.

Start: December 2014

Acute Pain Genomic Study

In preparation for future large-scale genome wide association studies, reliable methods must be developed for measuring perceived pain and for estimating the effects of potentially confounding factors such as appropriate covariates. The major objectives of our pilot investigation are to develop optimal methods to characterize the primary endpoint of the study-knee pain, and to gather preliminary data on genetic markers in the human genome that are associated with a certain pain phenotype. The specific issues for this study will be to carry out a preliminary gene association analysis of acute perioperative pain in individuals undergoing total knee replacement and to define a pain phenotype that is composed of multidimensional domains such as opioid consumption, inflammatory markers, anxiety level, degree of catastrophizing, etc. This pain phenotype has to be sensitive enough to pick up changes in pain experience that can be attributed to single nucleotide polymorphisms.

Start: February 2010

AR-Power Patient Powered Research Network

ArthritisPower is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), and other musculoskeletal conditions. Participants will provide information from their smartphones or personal computers. The information will be used by researchers to help patients and their providers make better, more informed decisions about treatment of RA/SpA and other musculoskeletal conditions. ArthritisPower is part of a larger national research network called PCORnet whose 33 network members have mapped their data to a common data model. Network members will be able to submit queries through PCORnet in order to answer a range of comparative effectiveness research questions. Data sharing across PCORnet will be accomplished using secure methods to prevent patient identification. There is no cost to participants for participating and no compensation is provided. Objectives: To establish a research registry to enable comparative effectiveness research in rheumatic diseases and other musculoskeletal conditions. All data collected using the ArthritisPower mobile app as part of a subject's use is stored with the ArthritisPower registry. This data will be used in conjunction with existing and future research studies. To use the data from this study to improve treatment and to further advance finding a cure for rheumatic diseases.

Start: April 2015

Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer.

In this study, in addition of conventional treatment, the efficacy of the medical device, Remedee One, in medical care of patients with peripheral osteoarthritis pain is evaluated.

Start: December 2020

Zimmer POLAR Persona - TKA (EMEA Study)

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include: Implant survivorship based on removal of a study device. Safety based on incidence and frequency of adverse events. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

Start: November 2013

Vivacit-E Post-market Follow-up Study

The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.

Start: October 2013

Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)

This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.

Start: June 2014

Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.

Start: November 2017

Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial

Osteoarthritis of the knee joint causes pain, stiffness, and restriction of joint movement in the knee joint due to degeneration of the knee cartilage. The purpose of osteoarthritis treatment is to improve the joint pain and prevent further damage to the joint. Selective Cox-2 inhibitors are the most commonly used nonsteroid anti-inflammatory drugs(NSAIDs) for the treatment of osteoarthritis of the knee joint. However, the safety of selective Cox-2 inhibitors is still controversial. Although these NSAIDs are effective in reducing pain and inflammation, they cannot be called a fundamental treatment for knee arthritis. Accordingly, interest in SYSADOA (Symptomatic Slow-acting Drugs for Osteoarthritis) is gradually increasing. Joins is a herbal anti-arthritic drug that has various physiological activities and a new concept of osteoarthritis treatment. It has anti-inflammatory, analgesic and joint cartilage protection effects as well as fundamental treatment. Joins is used to improve articular cartilage metabolism, can delay the progression of degenerative arthritis in the knee and compensate for the disadvantages of Selective Cox-2 inhibitors. However, when the selective Cox-2 inhibitor and Joins tablet are used alone, the therapeutic effect on knee degenerative arthritis may be limited. The purpose of this study is to investigate the therapeutic effect and safety of joining together with celecoxib for degenerative arthritis of the knee joint, and to determine the degree of analgesic and anti-inflammatory effects of the combination therapy.

Start: January 2021

Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)

The purpose of the SWIFT Trial is to answer two research questions. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative and long-term outcomes of TKA in extreme obesity? Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?

Start: January 2016

Reducing Recurrent Knee Flexion Contracture by Correcting Leg Length Discrepancy After Total Knee Arthroplasty for OA

Moving one's joints through their full range of motion (ROM) is crucial for health and wellbeing. Those who are unable to do so have difficulty carrying out simple activities like walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA) is the most common form of arthritis. About a third of people with knee OA develop knee flexion contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC before a knee replacement is a big risk factor for redeveloping one after the operation. Many people with a KFlC in the knee for surgery also have a KFlC in the other knee. The investigators believe that this non-surgical KFlC increases the risk of re-developing a KFlC in the surgical knee after surgery by encouraging bending of the surgical knee to avoid one leg being shorter than the other. No one has ever looked at whether fixing this leg length difference using a shoe lift would prevent this problem and there is little information to help design such a study. Here the investigators will see if testing shoe lift use for preventing KFlC is feasible. The investigators hypothesis is that a study evaluating the benefit of using a shoe lift to correct leg length difference in the non-surgical knee is feasible.

Start: August 2016

Virtual Environment Rehabilitation for Patients With Motor Neglect Trial

Motor neglect describes a loss of function without a loss of strength, reflexes or sensation. Motor neglect has been described in patients with traumatic brain injury, stroke and chronic pain conditions, e.g. complex regional pain syndrome. These conditions affect hundreds of thousands of patients in the UK each year and motor neglect is a significant obstacle in their rehabilitation towards a good outcome. By focussing on improving motor neglect, outcomes including function and quality of life for these groups of patients may significantly improve. Motor neglect is potentially reversible. Rehabilitation using repetition, feedback and motivation are beneficial for optimal outcome. Current protocols use face-to-face physical therapies which can not optimise intensity due to a lack of resources. Furthermore, engagement with exercise is recognised to be poor, in part, due to a lack of attention. Innovative technologies may well improve engagement. Furthermore, telemedicine, or remote delivery of healthcare, offer opportunities in resource management, which can be delivered through the use of such innovative technologies. Virtual reality systems have been designed and utilised in rehabilitation in various conditions, e.g post-stroke, cerebral palsy and Parkinson's disease. Studies demonstrate improved function in both upper and lower limbs. Potentially more effective treatments for motor neglect utilising such technology are therefore available but need more formal evaluation. This protocol describes a Phase II randomised controlled trial for both in-patients and out-patients requiring rehabilitation with motor neglect from neurological causes (stroke, traumatic brain injury) and chronic pain conditions (Complex Regional Pain Syndromes, chronic low back pain and referred leg pain (sciatica)). The intervention will be a novel interactive virtual reality system using established technology and tailored software used in conjunction with a treadmill. The control group will be the same screen showing random static images whilst on the treadmill. Rehabilitation for each group will be offered in 3-4 sessions per week for 2 weeks. Each session will last about 30 minutes supervised by a physiotherapist. Follow-up will be by questionnaire at weeks 2, 6 and 12 and by face-to-face consultation at weeks 2 and 12.

Start: May 2017

NexGen TM Tibia Clinical Outcomes Study

The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.

Start: October 2017

Massachusetts General Hospital Evaluation of DePuy ASR Hip System

DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery: ASR XL Hip System ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years. The purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.

Start: September 2012

Precision Assessment of Platelet Rich Plasma for Joint Preservation

Knee Osteoarthritis (OA) is a leading cause of premature disability in Veterans who develop knee OA at higher rates and younger ages than the population in general. For those with symptomatic early knee OA, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. In recent years, platelet rich plasma (PRP) injections have gained increasing attention for improving pain and function in patients with knee OA. Basic science studies also suggest that PRP may also potentially stimulate repair responses to articular cartilage. However, the mechanisms of action of PRP in the treatment of knee OA are unknown. Because autologous blood is used, the PRP composition differs between patients. It is also unknown whether these differences in PRP composition affect clinical outcomes. This study will address these gaps and provide critical new and objective information on PRP treatment effects in Veterans and additional women with early knee OA important to improving clinical use of this new treatment.

Start: April 2018

Colchicine for the Treatment of Osteoarthritis of the Knee

This prospective, double-blinded, placebo-controlled, randomized trial will enroll 120 SKOA subjects at the NYU Center for Musculoskeletal Care. Patients meeting entry criteria will be randomized 1:1 to treatment with colchicine or placebo daily for 3 months. Subjects will have detailed evaluation of standardized clinical pain outcomes, candidate peripheral blood biomarkers, baseline knee radiographs as well as MSK-US, and a subset will undergo evaluation of their synovial fluid.

Start: May 2019