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

NCT ID: NCT00731289

Last Updated: 2008-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-12-31

Brief 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

Keywords

Osteoarthritis; Knee; Hyaluronan; Gait Analysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

single intraarticular injection of hyaluronan 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

Group Type: EXPERIMENTAL

hyaluronic acid

Intervention Type: DRUG

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

2

single intraarticular injection of triamcinolone 1 ml (Volon A10®, 10mg triamcinolone acetonide, 10mg/ml)

Group Type: ACTIVE_COMPARATOR

triamcinolone

Intervention Type: DRUG

one intraarticular injection of triamcinolone 1 ml (Volon A10®, 10mg triamcinolone acetonide, 10mg/ml)

antiinflammatory intervention

Interventions

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

Intervention Type: DRUG

triamcinolone

one intraarticular injection of triamcinolone 1 ml (Volon A10®, 10mg triamcinolone acetonide, 10mg/ml)

antiinflammatory intervention

Intervention Type: DRUG

Other Intervention Names

20 mg/ml non-animal stabilized hyaluronic acid (NASHA); triamcinolone acetonide, 10mg/ml

Eligibility Criteria

Inclusion Criteria

• men and women between 35 and 80 years of age
• radiographically verified degenerative osteoarthritis of the knee (grade II or III according to the Kellgren and Lawrence classification)
• pain of at least 40 mm on a 100 mm visual analogue scale (VAS) at initial examination
• persisting pain for at least 6 months
• Lequesne-Score of at least 10 points
• good physical and mental status
• good compliance and agreement to participate in this study

Exclusion Criteria

• non-degeneratively induced osteoarthritis
• rheumatoid arthritis
• ligamentous instability or complete resection of the meniscus
• Sudeck´s disease
• operations of the affected knee within the last three months
• varus or valgus deformity of more than 15 degrees
• patellofemoral arthritis
• intraarticular therapy of the affected joint within the last 6 months with hyaluronan and three months with glucocorticoids
• severe systemic diseases (tumor, exacerbated diabetes mellitus, hyperthyroidism)
• anti-thrombotic medication or regular medication with NSAID/psychiatric pharmaceuticals
• infectious diseases
• alcohol abuse
• drugs
• psychiatric diseases or suicidal tendencies
• involvement in another study
• non-compliance
• acute hemarthrosis or joint effusion
• allergic predisposition
• skin infections or skin diseases around the knee

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Department of Orthopaedics and Rheumatology, University Hospital Marburg

Principal Investigators

Susanne Fuchs-Winkelmann, Prof. MD

Role: STUDY_CHAIR

University Hospital Marburg

Locations

Department of Orthopaedics, Movement Analysis Lab, University Hospital Münster, Germany

Münster, , Germany

Countries

Germany

Other Identifiers

3II Fuchs

Identifier Type: -

Identifier Source: org_study_id