View clinical trials related to Cartilage Diseases.
Filter by:The purpose of this study is to determine how safe a knee injection called Synvisc-One® is in patients with a condition called chondromalacia patella and how well in works in treating the condition. Chondromalacia patella is a common cause of kneecap pain or front knee pain. Often called "Runner's Knee," this condition often affects young, otherwise healthy individuals. Chondromalacia is due to irritation of the undersurface of the kneecap. The undersurface of the kneecap, or patella, is covered with a layer of smooth cartilage. This cartilage normally glides effortlessly across the knee during bending of the joint. In some individuals, the cartilage on the undersurface of the knee cap becomes irritated and soft, resulting in pain. Potential treatments for this condition include rest, injections (numbing or anti-inflammatory medications to reduce swelling and pain), and/or guided strengthening exercises which may help reduce pain. Other Treatments are being evaluated. This study is about Synvisc-One® an experimental device that has been approved by the Food and Drug Administration (FDA) for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond to treatments that do not involve drugs or surgery and simple pain medication such as acetaminophen. Synvisc-One® is a gel-like substance that, when injected into a joint, acts to lubricate and cushion the joint. Synvisc-One® is made from hyaluronan, which is a molecule that is found normally in joint fluid. Synvisc-One® has not been proven to be safe or helpful in patients with chondromalacia patella (cartilage irritation or softening of the undersurface of the 'knee cap'). So far, this drug/device has been given to over 10,000 people who have knee pain (due to osteoarthritis) and has been proven safe and effective in patients with moderate to severe pain due to knee joint osteoarthritis.
Platelet-rich plasma (PRP) has been used as an alternative to non-operative treatments for increasing the rate of cure in bone and soft-tissue regeneration, although there are very few clinical studies regarding the treatment of articular cartilage damage. Therefore, our study proposes non-surgical intervention for patients with articular cartilage damage and who are experiencing knee pain caused by this damage. This study was conducted as a single medical center. It was an uncontrolled, prospective clinical trial, and the study subjects included 44 patients who were suffering from early osteoarthritis and degenerative chondropathy; they were between 18 and 65 years of age and were included in the study irregardless their sex. PRP was injected twice intraarticulary within an interval of four weeks. The pain scores and functional scores were compared two months, four months, and six months following the second injection was completed, using the VAS, the Lysholm knee scale, and the Cincinnati knee rating system.
The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP) to treat knee degenerative articular cartilage pathology could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation. A power analysis has been performed for the primary endpoint of IKDC (International Knee Documentation Committee) subjective score improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group. Considering a possible drop out of 15%, 96 patients per group are required for total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then assigned to two different treatment groups, according to a randomization list. The first group of treatment consists of three weekly intra-articular injections of autologous PRP obtained with the following procedure: a 150-ml autologous venous blood sample undergoes 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of PRP. This unit of PRP is then divided into 4 small units of 5 ml each. One unit is sent to the laboratory for analysis of platelet concentration and for a quality test, 3 units are stored at -30° C. The second treatment group consists of patients receiving three weekly injections of hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500 kDa). To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain autologous PRP which will be used only in half of them, according to the aforementioned randomization list. One week after the PRP production, the injective treatment starts, with 3 weekly injections of PRP or HA. At the moment of the injection the syringe is properly covered to prevent the patient from discovering the substance he was receiving. After the injection, patients are sent home with instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the affected area to relieve pain. During this period, the use of non-steroidal medication is forbidden. Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using clinical subjective scores and objective parameters to determine clinical outcome (see 'Outcome measure' section). Patient satisfaction and adverse events will be also reported. All the clinical evaluations are performed by a medical staff not involved in the injective procedure, in order to keep the study double blinded. At the end of the study, the nature of the injected substance is revealed to the patients.
In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.
This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.
Acute effects of physical exercise on the deformational behavior of articular cartilage and changes in cartilage oligomeric matrix protein (COMP) are definite. However, conclusive positive effects of fitness exercise on functional adaptation of articular cartilage have not been proved.Therefore, in this parallel-group randomized control trial, the investigators tested the hypothesis that adequate amount of physical exercise with enough impact would be able to stimulate the functional behavior of articular cartilage. The investigators evaluated 44 healthy males for their physical fitness levels and their blood samples were obtained before, immediately after and 0.5 h after a 30-min walking exercise. Thereafter, participants were assigned to the running, the cycling, the swimming and the control groups. At the end of 12-weeks of intervention, same measurement procedures were applied. Mixed repeated-measures ANOVA design was used for statistics. (Level of evidence: 2)
The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.
The purpose of this study is to establish the normality of sonographic synovial measures in joints more affected in rheumatoid arthritis patients and establish, in those joints, a sonographic value of synovium predictive of rheumatoid arthritis.