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

This study has been completed.
Sponsor:
Collaborator:
University Hospital Muenster
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00731289
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Osteoarthritis
Drug: hyaluronic acid
Drug: triamcinolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intra-Articular Injections of Durolane® in the Treatment of Osteoarthritis in the Knee

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • visual analogue scale for pain (VAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • gait analysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731289

Locations
Germany
Department of Orthopaedics, Movement Analysis Lab, University Hospital Münster, Germany
Muenster, Germany, 48149
Sponsors and Collaborators
Philipps University Marburg Medical Center
University Hospital Muenster
Investigators
Study Chair: Susanne Fuchs-Winkelmann, Prof. MD University Hospital Marburg
  More Information

No publications provided

Responsible Party: Adrian Skwara, Department of Orthopaedics and Rheumatology, University Hospital Marburg
ClinicalTrials.gov Identifier: NCT00731289     History of Changes
Other Study ID Numbers: 3II Fuchs
Study First Received: August 5, 2008
Last Updated: August 7, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Philipps University Marburg Medical Center:
Osteoarthritis
Knee
Hyaluronan
Gait Analysis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014