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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00731289
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
University Hospital Muenster
Information provided by:
Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: hyaluronic acid Drug: triamcinolone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intra-Articular Injections of Durolane® in the Treatment of Osteoarthritis in the Knee
Study Start Date : July 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Arm Intervention/treatment
Experimental: 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
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
Other Name: 20 mg/ml non-animal stabilized hyaluronic acid (NASHA)

Active Comparator: 2
single intraarticular injection of triamcinolone 1 ml (Volon A10®, 10mg triamcinolone acetonide, 10mg/ml)
Drug: triamcinolone

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

antiinflammatory intervention

Other Name: triamcinolone acetonide, 10mg/ml

Primary Outcome Measures :
  1. visual analogue scale for pain (VAS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. gait analysis [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00731289

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Department of Orthopaedics, Movement Analysis Lab, University Hospital Münster, Germany
Muenster, Germany, 48149
Sponsors and Collaborators
Philipps University Marburg Medical Center
University Hospital Muenster
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Study Chair: Susanne Fuchs-Winkelmann, Prof. MD University Hospital Marburg
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Responsible Party: Adrian Skwara, Department of Orthopaedics and Rheumatology, University Hospital Marburg Identifier: NCT00731289    
Other Study ID Numbers: 3II Fuchs
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: August 2008
Keywords provided by Philipps University Marburg Medical Center:
Gait Analysis
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Hyaluronic Acid
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Protective Agents