NCT00731289

Gait Patterns After Intraarticular Treatment of Patients With Osteoarthritis of the Knee

Efficacy and Safety of Intra-Articular Injections of Durolane® in the Treatment of Osteoarthritis in the Knee

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to analyse the difference of the functional and clinical outcome after intraarticular treatment of patients with osteoarthritis of the knee with a single injection of hyaluronan (HA) or Triamcinolone (TA) with respect to the quality of life during the study period.

Detailed description

Osteoarthritis (OA) is the most common chronic joint disease of the aging patient. The primarily affected joints are the knee and hip. The progress of the disease has an important influence on the patient´s life, including functional and social activities, body image and emotional well being. Furthermore, socioeconomic aspects play an eminent role in the treatment of osteoarthritis in joints. In non-operative treatment, pain reduction and improved function are the primary goals. It is important to distinguish between systemic and local therapeutic options. In the systemic treatment, palliation of pain can be achieved by simple analgetics, non- steroidal anti-inflammatory drugs and opioids. Local therapy can selectively treat the symptomatic joint. Intraarticular application of different drugs by injection can be performed. Glucocorticoids are the most commonly used intraarticular agents, which reduce pain and improve function and well being. In recent years, the intraarticular use of different hyaluronan (HA) products became more widely accepted. Hyaluronan is a physiological component of the synovial fluid and cartilage matrix. It is responsible for the viscoelastic properties of the synovial fluid. In osteoarthrotic joints, the molecular weight and the concentration of endogenous HA are decreased compared with healthy joints. This implies a reduction of the viscoelasticity of the synovial fluid. In order to restore this viscoelasticity, augment the flow of the synovial fluid, normalise the synthesis and inhibit the degradation of endogenous hyaluronan, an application of exogenous HA can be performed. The therapeutic effects and the safety of intraarticular application of HA in the treatment of OA in the knee have been demonstrated in several clinical trials. Until now there are only three studies that objectively analysed few aspects of the functional outcome after treatment with HA.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	hyaluronic acid	one intraarticular injection of hyaluronan (HA) 3 ml (Durolane®, 20 mg/ml non-animal stabilized hyaluronic acid (NASHA) in buffered physiological sodium chloride solution pH 7 in one pre-filled glass syringe in sterile pack
DRUG	triamcinolone	one intraarticular injection of triamcinolone 1 ml (Volon A10®, 10mg triamcinolone acetonide, 10mg/ml) antiinflammatory intervention

Timeline

• Start date: 2003-07-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2008-08-08
• Last updated: 2008-08-08

Locations

1 site across 1 country: Germany