NCT00731289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

August 5, 2008

Last Update Submit

August 7, 2008

Conditions

Osteoarthritis

Keywords

OsteoarthritisKneeHyaluronanGait Analysis

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale for pain (VAS)

    12 weeks

Secondary Outcomes (1)

  • gait analysis

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Drug: triamcinolone

Interventions

hyaluronic acidDRUG

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

Also known as: 20 mg/ml non-animal stabilized hyaluronic acid (NASHA)
1
triamcinoloneDRUG

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

Also known as: triamcinolone acetonide, 10mg/ml
2

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic AcidTriamcinoloneTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Susanne Fuchs-Winkelmann, Prof. MD

    University Hospital Marburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

July 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

DE(1)