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Osteoarthritis, Knee clinical trials

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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: NCT01668511 Completed - Osteoarthritis Clinical Trials

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee

Start date: September 2012
Phase: Phase 1
Study type: Interventional

To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.

NCT ID: NCT01666873 Completed - Clinical trials for Osteoarthritis of the Knee Joint

Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.

Start date: September 2012
Phase:
Study type: Observational

Evaluation of the clinical results after total knee prosthesis, and correlation with the alignment of the lower limb. Radiological measurements by means of 3D technology will be performed. The clinical result will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee score-questionnaire).

NCT ID: NCT01654575 Completed - Osteoarthritis Clinical Trials

Methotrexate in Symptomatic Knee Osteoarthritis

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

Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.

NCT ID: NCT01654302 Completed - Knee Osteoarthritis Clinical Trials

Efficacy and Safety of Synera in Osteoarthritis Pain

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Knee osteoarthritis (OA) can result in significant pain and limitation of function. A number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. This study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee OA.

NCT ID: NCT01649518 Completed - Clinical trials for Osteoarthritis, Knee

A Measurement of Knee Osteoarthritis Usual Care

Start date: November 2012
Phase: N/A
Study type: Observational

Osteoarthritis is the most common affection of joints worldwide. Multiple international guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless there seems to be a gap between usual care and the preferred one. A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy was developed by a multidisciplinary expert team. This project aims to map usual care and to explore the gaps between usual care and international guidelines in a second stage. This will enable us to develop a tightly targeted quality improvement intervention later on.

NCT ID: NCT01645176 Completed - Clinical trials for Osteoarthritis of the Knee

Hydroxychloroquine/Atorvastatin in the Treatment of Osteoarthritis (OA) of the Knee

Start date: May 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is to learn about the effects in inflammation and pain in patients with Osteoarthritis of the knee. These medications are FDA approved and commercially available.

NCT ID: NCT01641874 Completed - Knee Osteoarthritis Clinical Trials

The McKenzie System With Arthritic Knees: Do Some Knees Respond to Specific Exercise More Than General or no Exercise

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to explore if a subgroup of people with osteoarthritic knees can be identified using the McKenzie System of Mechanical Diagnosis and Therapy. In the spine this subgroup, termed derangement,has been shown to respond rapidly to specific directional exercises. The trial will explore whether these derangements in the knee respond to specific exercises compared to a control group with no exercises and non-derangement knees given general exercises.

NCT ID: NCT01641471 Completed - Pain Clinical Trials

Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relief Following Total Knee Arthroplasty (TKA)

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

Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)

NCT ID: NCT01638962 Completed - Clinical trials for Osteoarthritis, Knee

The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT

EXERPHARMA
Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effects of neuromuscular exercise and analgesic use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA). It is expected that the two groups will receive equipotent pain relieving effect, despite this, the investigators expect a between group difference in knee joint load, and the exercise group will have a reduction in knee joint load.