Effectiveness Study of the Ivivi SofPulse for Pain Amelioration in Adults With Mild to Moderate...
Knee OsteoarthritisThe purpose of this study is to determine the effectiveness of non-thermal Pulsed Radio Frequency (PRF) treatment with the Ivivi SofPulse for amelioration of knee pain in patients with mild to moderate Osteoarthritis and to determine the duration of clinical benefit following discontinuation of treatment.
CRx-102 Osteoarthritis Multicenter Evaluation Trial
Knee OsteoarthritisCRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur...
Knee OsteoarthritisTraumatic Arthritis of Knee4 moreMicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty
Total Knee ArthroplastyKnee Disease2 moreThe aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice.
The Effect of AposTherapy on Knee Pain
Knee OsteoarthritisKnee PainAposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with knee osteoarthritis since patients with knee osteoarthritis have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee OA, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population.
Trial Evaluating multimOdal toPical Cream In CompArison to pLacebo (TOPICAL)
Knee OsteoarthritisRandomized controlled trial regarding the efficacy of a multimodal topical analgesic, Multiprofen, in comparison to placebo cream treatment on knee pain and function in patients with knee osteoarthritis.
Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)
OsteoarthritisKneeThis study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment...
OsteoarthritisKneeThis is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Patients with chronic knee pain, with moderate to severe osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed conservative therapy will be screened for the study. Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic guided single diagnostic block of the geniculate nerves (superior medial, superior lateral, and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine). Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4, 12, 24 and 52 weeks. Outcome measures will be: Visual analogue scale (VAS) both while at rest and during ambulation, Oxford knee scores, WOMAC, and global perceived effect.
Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823...
OsteoarthritisThe 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.
Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total...
OsteoarthritisKneeThis study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas: Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design? Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design? Answering these questions will allow surgeons to use both designs appropriately in different demand populations. This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.