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

August 7, 2008 updated by: Philipps University Marburg Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, 48149
        • Department of Orthopaedics, Movement Analysis Lab, University Hospital Münster, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • triamcinolone acetonide, 10mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual analogue scale for pain (VAS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
gait analysis
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Collaborators

University Hospital Muenster

Investigators

  • Study Chair: Susanne Fuchs-Winkelmann, Prof. MD, University Hospital Marburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3II Fuchs

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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