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Cartilage Diseases clinical trials

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NCT ID: NCT01747018 Completed - Clinical trials for Early Osteoarthritis

Platelet Rich Plasma Injection for Knee Pain

Start date: February 2011
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT01733186 Completed - Clinical trials for Degeneration Articular Cartilage Knee

Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects

Start date: January 7, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT01690689 Completed - Clinical trials for Articular Cartilage Disorder

Investigation of a Customized Femoral Resurfacing Implant

Knee100
Start date: December 2012
Phase: N/A
Study type: Interventional

The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.

NCT ID: NCT01670578 Completed - Clinical trials for Osteoarthritis, Knee

Platelet-rich Plasma vs Viscosupplementation in the Treatment of Knee Articular Degenerative Pathology

PRP2009
Start date: February 2009
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01656902 Completed - Clinical trials for Traumatic Articular Cartilage Defects in the Knee Joint

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects

N3D
Start date: May 2013
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01626677 Completed - Clinical trials for Degenerative Osteoarthritis

Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect

Start date: June 2012
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01576159 Completed - Osteoarthritis Clinical Trials

Serum Cartilage Oligomeric Matrix Protein Levels After 12 Weeks of Different Exercises

Start date: January 2008
Phase: Phase 0
Study type: Interventional

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)

NCT ID: NCT01527201 Completed - Meniscal Tear Clinical Trials

The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

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

The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.

NCT ID: NCT01476865 Completed - Clinical trials for Arthritis, Rheumatoid

Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients

Start date: March 2010
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01473199 Completed - Cartilage Injury Clinical Trials

BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Start date: November 2011
Phase: N/A
Study type: Interventional

Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.