View clinical trials related to Osteoarthritis, Knee.
Filter by:Treatment options for individuals who have advanced knee osteoarthritis (OA) and a body mass index (BMI) ≥35 kg/m2 are limited, and this patient population may be neglected in current clinical care pathways for OA management. These individuals are considered to be at high risk for complications with total knee arthroplasty (TKA), and as a result may not be eligible for this procedure unless they lose significant weight. However, there is limited evidence for endorsing weight loss as beneficial prior to TKA. Further, unsupervised weight loss could put patients at risk for muscle loss and development of sarcopenic obesity, a health condition that negatively impacts mobility and mortality. This suggests that weight loss might not be the primary treatment goal for this patient population. Integrated non-surgical treatment approaches are needed that can target the specific needs of this knee OA patient group. This study will examine the feasibility and acceptability of a personalized, multicomponent intervention, and its effects on body composition and physical function compared to usual care.
The primary objective of this study is to evaluate the safety and efficacy of CNTX-6970 for the treatment of pain related to OA of the knee compared to placebo. CNTX-6970 is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee.
The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.
In terms of the surgical treatment of the cartilage injury, various techniques and ways are created to repair or regenerate articular surface of synovial joint following traumatic damage or degeneration of the cartilage. The option for surgical treatments based on the size and depth of the cartilage knee injury may include knee debridement, radiofrequency, drilling, microfracture, mosaicplasty, allogenic osteochondral transplantation and autologous chondrocyte transplantation. The first two techniques mentioned have been used in treating the cartilage knee injury involving the partial defects meanwhile the latter techniques have been used for Grade III and IV cartilage defects based on ICRS. However, most of the surgical options up only provide more of Type I collagen rather than Type II collagen. The available treatments are more symptomatic rather than preventive or regenerative. Stem cell has big potential in this area where it has ability to differentiate to cartilage. As allogeneic umbilical cord blood MSCs are readily available and can be administered immediately, this study therefore aims to prove the efficacy of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) for treating large defects knee injury. The study is a prospective, randomized controlled, open label, phase IIb clinical trial, involving 50 patients with large defects of cartilage injury for follow-up duration of 24 months. Patients will be assigned into 2 arms; Arm A - 25 subjects will receive Chondrocell-EX (UC-MSCs) and Arm B - 25 subject will receive marrow cellution. All patients will undergo debridement prior to receiving their assigned treatment. The patients will be assessed on KOOS, IKDC, VAS and MRI.
The purpose of this open-label, thirty-nine weeks-long clinical study is to investigate the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to conventional treatment in comparison to conventional therapy alone and assessment of its eventual prolonged effectiveness after nine and twenty-four weeks without treatment. The long-term effects of acupuncture on KOA are not yet confirmed. A safety assessment will be done. It will be interesting to find possible additional benefits of acupuncture while treating knee/s with an advance determined acupuncture protocol for KOA and Kidney Deficiency Syndrome (KDS) since Traditional Chinese Medicine (TCM) theory connects KOA with KDS. Acupuncture treatment point prescription will use local points for KOA and non-local points with their influence on KOA through Kidney deficiency as a root cause. The deep layered chronic pathological condition like KOA requires a higher number of acupuncture treatments. This study will provide three cycles of acupuncture treatments to participants of the Acupuncture (A) group, which are three weeks long each, with treatment frequency three times weekly. It is expected that the study design with twenty-seven acupuncture treatments of KOA in fifteen weeks achieves improvement with the KOA and Kidney Deficiency Syndrome (KDS), additionally. Also, treatment effectiveness on KOA and KDS is expected to persist at the final assessment nine weeks after the last acupuncture treatment. That could confirm the holistic aspect of TCM. Sixty-four patients with symptomatic KOA will be randomly allocated into the A group or C group (standard care) according to their permanent, unique, and coincidental Personal Identification Number which is randomly given to all citizens in Croatia. Before the experiment starts participant's demographic and disease parameters of both groups will be compared at baseline. Prescribed acupuncture protocol will be provided firstly to the Acupuncture group. Objective assessments of therapeutic efficacy will be done by a physiatrist at three time-points: baseline, after final acupuncture treatment (15th Week), and at the 24th Week. Subjective evaluation of symptoms intensity, by participants, will be assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total score and subscales, Visual Analogue Scale (VAS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every three weeks till the 24th week (nine assessments with baseline one). Analgesics taken by participants in the last three days before every assessment will be recorded. Participants from the study were promised to receive equal acupuncture treatment after completion of the experiment and belonging assessments if they were randomised into the non-acupuncture group (Control). So, the participants of the C group cross over and after the 24th week of this study start with the identical acupuncture treatment protocol. This study added later the 10th identical assessment to both groups of participants to estimate the within-subject C group effect of the acupuncture treatment protocol and to estimate the duration of treatment effect in the A group 24 weeks after the last acupuncture treatment. Also, in the 24th week was added the Lequesne index, as a more objective and clearer measure of symptomatic and functional improvement of the knees. Participants were asked to fill out the questionnaire according to the actual condition and according to a memory of "how it was before the experiment start". Hypothesis: A decrease in symptom intensity could be achieved after treatment in the experimental group compared to the control.
Phase 2 multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, and local tolerability of G001 topical gel compared to matching Vehicle topical gel in patients with symptomatic OA of the knee. Each patient's participation is approximately 7 weeks (~1 week screening, 4 weeks of treatment, and 2 weeks of post-treatment follow-up). Eligible patients with adequate OA pain in the index knee are randomized (1:1 allocation ratio) at the Baseline/Flare Visit 1. Following screening, prior NSAID and/or acetaminophen use is discontinued to allow for washout and symptom flare. Patients are instructed to rate their worst daily and nightly pain in their daily diary, as well as to document all study drug applications and any rescue medication (acetaminophen) use for breakthrough pain. Acetaminophen may be used as rescue medication only, except within 12 hours prior to the Baseline Visit and within 12 hours prior to any post-baseline efficacy assessments (Weeks 2, 4, and 5). Patients are instructed to return to the clinic 3 to 7 days after the last study drug application for Flare Visit 2, and within approximately 2 weeks after the last study drug application for end-of-study evaluations.
The purpose of this study is to report the feasibility and determine the initial effects of 18 sessions of real-time gait biofeedback delivered over a 6-week period on retention and transfer of normalized gait biomechanics and improvements in indicators of early post-traumatic osteoarthritis development in those with an anterior cruciate ligament reconstruction (ACLR) at 6 and 8-week posttests.
Umbilical cord blood mononuclear cells contain hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), endothelial progenitor cells and other pluripotent stem cells, as well as immature immune cells, which can differentiate into chondrocytes, hematopoietic, epithelial, endothelial and nerve cells. It gives the ability to promote wound healing and vascular microcirculation reconstruction, and has the potential to treat many diseasesHowever, clinical studies on cord blood mononuclear cells in knee osteoarthritis have not been reported in the literature. Therefore, this study aims to explore the safety and effectiveness of cord blood mononuclear cells in the treatment of patients with knee osteoarthritis.
This clinical trial study is conducted in Vietnam to assess the efficacy and tolerability of Proteoglycan F in the treatment of primary knee osteoarthritis. 72 outpatients (40-80 years old) were diagnosed with primary knee osteoarthritis and met the American College of Rheumatology 1991 criteria. Patients have to be symptomatic for ≥ 3 months before enrollment and have a radiologic grade II and III measured by the Kellgren-Lawrence criteria. The study was designed as a Prospective, Randomized, Double-blind Controlled trial. Each patient will be follow during 24 weeks of intervention, follow-up every 4 weeks.
Recent research in strength training physiology revealed that implementation of occlusion garments around the proximal aspect of the lower limbs in combination with low load strength training causes a reduced blood flow and thus providing a high metabolic stimulus, causing a training effect similar to high load training. This study will investigate the added effect of BFR focussing on functional outcome, pain-management and lower limb strength in patients with knee osteoarthritis. Therefore, 234 patiens will be divided into three equal groups (n=78), (control group, sham group and BFR-group) which will be subjected to a 12-week during standard strength training program, 2 times a week for 60 minutes. The first group, which will be submitted to low load resistance training commonly used in contemporary physiotherapy for OA, will serve as a control group whereas both the BFRT and Sham groups will objectify the additional value of implementing vascular occlusion in respective low load resistance training protocol.