View clinical trials related to Osteoarthritis, Knee.
Filter by:The purpose of this study is to determine the safety and efficacy of the 40 mg and 100 mg doses of allogeneic micronized dehydrated human amnion/chorion membrane (micronized DHACM) injectable compared to 0.9% sodium chloride injection, placebo control for the treatment of knee osteoarthritis
This is a multi-center first-in-human prospective clinical investigation to evaluate the safety and performance of the FibroFix™ Cartilage P Implant and Drill Set. The Implant is a medical device designed by Orthox Ltd. to repair a damaged area of cartilage within the knee joint. The aim is to 75 participants over two Stages: In STAGE I, up to a total of 6 subjects will be recruited and safety assessed after 6 months of follow-up. In Stage II an additional 69 subjects. The subjects will be followed up for 2 years with MRI imaging, then a further 8 years with patient outcome questionnaires.
This is a pilot investigator initiated/sponsored clinical trial to evaluate the feasibility of using real-time DexCom G6 continuous glucose monitor (CGM or glucose sensor) trend data and an insulin-dosing algorithm to control the glucose levels of type 2 diabetic patients undergoing hip/knee orthopedic surgery at Thomas Jefferson University Hospital (TJUH). Blinded CGM glucose data will be recorded prior to hospital admission, during hospital admission, and after hospital discharge to evaluate glucose control in this diabetic patient population in relationship to clinical outcomes (20 days of recorded blinded CGM data maximum). Prior studies have associated hyperglycemia, hypoglycemia, and glycemic variability with an increased incidence of nosocomial infection, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias, mental status changes, hospital length of stay, and cost. The 20 type 2 diabetic patients in the Control Group will be managed according to standard-of-care methods at TJUH using finger-stick blood glucose measurements in an attempt to maintain the patient's blood glucose levels in the desired target range (80 to 180 mg/dL). Three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The 40 type 2 diabetic patients in the Investigational Group will be managed by the orthopedic floor nurses using the real-time DexCom G6 CGM trend data to determine the appropriate therapy to maintain the patient's glucose levels in the desired target range (80 to 180 mg/dL). In addition, three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The primary objective of this pilot study is to observe the blood glucose values and glucose sensor (CGM) values of diabetic patients before, during and after hospitalization for hip and knee arthroplasty surgery to determine whether there is a correlation between glucose control and clinical outcomes. This pilot data will be used to plan a future clinical trial in orthopedic surgery patients using CGM to determine patterns of hyperglycemia, hypoglycemia, and glycemic variability that correlate with clinical complications, hospital length of stay, and cost.
This study is a 3-arm, double-blind, randomized trial comparing the clinical outcomes of Zilretta, Synvisc One, and Monovisc for knee OA.
The study purpose is to determine if giving pregabalin before and after total knee arthroplasty (TKA) can improve pain and meaningful function after surgery in patients that have central sensitization (CS). Participants will be identified who are indicated for TKA. Interested patients will complete a standard Knee Injury and Osteoarthritis Outcomes Score (KOOS), asked their pain score (on a scale of 0 to 10), and complete the Central Sensitization Inventory (CSI). If they meet inclusion criteria and agree to participate, they will complete the informed consent before being randomized 1:1 to usual care (control group) or pregabalin (study group). The study group participants will take pregabalin starting 7 days prior to surgery. They will also be scheduled to have a pre-operative physical therapy (PT) appointment which will include tests and measures standard to PT. Tests will include a Timed Up and Go Test (TUG), a Sit to Stand 5 Times Repeat Test (5TSTS) and Patient Specific Functional Scale (SFS) measures. On the day of surgery participants will be asked about any adverse effects of study medication and determine need to withdraw from study. The post-operative plan will be reviewed, including dose of study medication. For the pregabalin group the doses will be doubled for 7 days, then reduced for 7 days, then off. All participants will be given standard peri-operative pain management for TKA . All participants will complete standard of practice physical therapy. After surgery (usually within 7 days) a physical therapist will perform standard post-operative evaluation and treatment for all participants. This includes a re-evaluation of the same pre-operative functional tests of TUG, 5TSTS and PSFS outcome measures. The study pharmacist will also call the patient to determine if there are any medication-related adverse effects and how much opioid medication the patient is taking at that time (morphine milligram equivalents- MME/day on average). At the 6 week post-operative visit all participants will again complete the KOOS survey, report a pain score, complete the CSI survey and determine MME based on patient report of quantity of opioid medication used. A physical therapist will complete the functional assessment of the TUG, 5TSTS and PSFS outcome measures.
Medial subperiosteal release is a commonly performed technique to improve surgical exposure and aid in joint balancing. This is a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery. The intervention will be randomly assigning subjects undergoing TKA into two groups, one receiving subperiosteal release using a scalpel (aka sharp medial peel) and the other via electrocautery.
Over 30 million Americans are currently affected by osteoarthritis (OA), with prevalence expected to increase 40% by 2025 as a result of the aging population and obesity epidemic. Specifically, symptomatic knee OA is a leading cause of disability. Although originally classified as non-inflammatory arthritis, recent studies suggest that a relationship exists between joint inflammation and OA. Specifically, the complex interaction between sites of local tissue damage and immune cells leads to a state of chronic joint inflammation which may play a key role in disease pathogenesis. The evidence suggesting a role of inflammation in disease progression makes anti-inflammatory agents ideal candidates for symptom management. Astaxanthin, a keto-carotenoid present in many aquatic animals, including salmon, shrimp, and lobster, is an FDA-approved nutraceutical that has powerful antioxidant and anti-inflammatory properties coupled with remarkable safety and tolerability. This prospective, blinded, randomized, placebo-controlled pilot study will evaluate the effect of astaxanthin in reducing inflammation, controlling pain, and improving physical function in patients with advanced knee osteoarthritis awaiting total joint replacement surgery. Levels of pro- and anti-inflammatory cytokines and chemokines will be measured following the completion of a daily oral regimen of astaxanthin vs. placebo. Additionally, patient-reported outcome measurements assessing physical function and pain interference will be obtained prior to and following completion of treatment allowing for a comparison between treatment groups. Study outcomes will provide evidence to support astaxanthin supplementation as a cost-effective, added strategy for symptom management in patients with advanced osteoarthritis.
To evaluate the efficacy of ACP-044 compared with placebo in the treatment of pain associated with osteoarthritis of the knee
This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.
This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.