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Joint Diseases clinical trials

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NCT ID: NCT02507258 Withdrawn - Joint Disease Clinical Trials

PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

Start date: December 2017
Phase:
Study type: Observational

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

NCT ID: NCT02341079 Withdrawn - Osteoarthritis Clinical Trials

Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

Start date: March 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.

NCT ID: NCT02324712 Withdrawn - Clinical trials for Temporomandibular Joint Disorders

Cytokine and Growth Factor Changes and Correlation With Clinical Outcomes Following Acupuncture for TMD

Start date: n/a
Phase: N/A
Study type: Interventional

Purpose: 1) To investigate differences in pro-inflammatory and anti-inflammatory cytokines and growth factors in the circulating blood (and cytokine levels only in saliva) of patients with chronic temporomandibular disorder (TMD) before and after acupuncture; 2) To determine differences in cytokine profiles between real and sham acupuncture in circulating blood of patients with chronic TMD; and 3) To explore correlations between these changes and clinical outcomes. Participants: Patients with chronic TMD pain recruited through the University of North Carolina-Chapel Hill (UNC-CH) Orofacial Pain Clinic. Procedures (methods): Participants will complete a self-administered questionnaire assessing TMD-related comorbidity. During the initial visit, study examiners will record clinical characteristics of muscles and joints of the head, neck and body according to newly recommended diagnostic criteria (DC) for TMD. Clinical outcomes include a pain index (computed from numeric rating scales) of masseter, temporalis and the supplemental painful muscles, and patient-reported symptoms (using the Measure Yourself Medical Outcome Profile; MYMOP) and pain intensity (using the Pain Scale). Blood (5 cc) will be taken before and after acupuncture treatments. Participants will self-collect pre-treatment and post-treatment saliva samples. Patients will receive 4 acupuncture treatments, once per week for 4 weeks. The primary outcome measure is change in IL-8 levels in circulating blood and saliva after 4 weeks of real acupuncture compared with sham acupuncture. Secondary outcome measures include comparing changes in levels of nerve growth factor (NGF), tumor necrosis factor-alpha (TNFα),vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), basic fibroblast growth factor (bFGF), and IL-1α, IL-2, IL-4, IL-6 and IL-10, before and after real acupuncture at Week 1 compared with sham acupuncture and before and after real acupuncture at Week 4 compared with sham acupuncture. The exploratory outcome measure is correlation between changes in cytokine levels and clinical variables after 4 weeks of real acupuncture compared with 4 weeks of sham acupuncture.

NCT ID: NCT02202070 Withdrawn - Clinical trials for Temporomandibular Joint Disorders

Botox for Treatment of TMJ Disorder With Bruxism

TMJ
Start date: January 2015
Phase: Phase 1
Study type: Interventional

Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up. The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study

NCT ID: NCT02093364 Withdrawn - Clinical trials for Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture

A Focused Registry to Document the Use of the Short- or Long-stemmed Radial Head Prosthesis (RHP)

Start date: July 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.

NCT ID: NCT02027974 Withdrawn - Clinical trials for Degenerative Joint Disease

Post-Market Study of the ICONACY Hip System

Start date: December 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.

NCT ID: NCT01954511 Withdrawn - Clinical trials for Temporomandibular Joint Dysfunction Syndrome

Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders

Start date: July 2012
Phase: N/A
Study type: Interventional

The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.

NCT ID: NCT01920373 Withdrawn - Clinical trials for Degenerative Joint Disease

Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint

Start date: November 2013
Phase: Phase 1
Study type: Interventional

1.0 BACKGROUND AND HYPOTHESES 1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint. 1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus. 1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation

NCT ID: NCT00808613 Withdrawn - Arthropathy of Knee Clinical Trials

Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

Start date: December 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs.

NCT ID: NCT00754637 Withdrawn - Joint Disease Clinical Trials

Microplasty Tibial Tray Data Collection

MTT
Start date: December 2009
Phase: N/A
Study type: Observational

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.