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Osteoarthritis, Knee clinical trials

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NCT ID: NCT01674816 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration

Start date: December 1, 2025
Phase: N/A
Study type: Interventional

Problem: Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee. Hypothesis: A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting. Objectives : - Demonstrating the capacity of the system to precisely measure 3D knee kinematics - Quantifying the reproducibility of the kinematic measurements - Measuring the impact of knee surgical procedures on knee kinematics - Assessing the correlations between measured articular kinematics and clinical results after knee surgery - Integrating the novel measuring system to the surgical flow of three knee surgical procedures - Quantifying the precision and reproducibility of the surgical actions guided by the system - Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

NCT ID: NCT01671917 Completed - Knee Osteoarthritis Clinical Trials

Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

EDEX
Start date: October 4, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

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: NCT01659229 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Fluoroscopic Analysis of PFC CR 150 Versus Standard PFC CR Total Knee Arthroplasty Implants in Deep Flexion

Start date: October 2011
Phase: N/A
Study type: Observational

The investigators are comparing the range of movements the knees of patients who had total knee replacement surgery for knee osteoarthritis. In the study arm, the implant used was a Sigma Cruciate Retaining (CR) Press Fit Condylar (PFC) 150, which is a high flexion knee system designed to combine function with wear resistance. It can accommodate up to 150 degrees of knee flexion. In the cohort arm, the implant used was the standard Sigma CR which can accommodate up to 120 degrees of flexion.

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: NCT01647243 Recruiting - Clinical trials for Osteoarthritis, Knee

Preoperative Strength Training in Patients With Total Knee Arthroplasty

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

The purpose of this study is to investigate if preoperative strength training will result in faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).