search
Back to results

Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Injection of Hyaluronan or Saline
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Hyaluronan, Gonarthrosis, Osteoarthritis,knee, Double-blinded, Placebo controlled, Randomised

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients, men/women age > 60 years with clinical, Radiological and possible arthroscopical verified knee osteoarthritis. Knee pain on the day of examination scoring more than 20 mm on a visual analogue scale (VAS) at baseline. Exclusion Criteria: Age below 60 Unconsciousness Psychosis Demens Ingestion of drugs that may influence the results of the clinical examinations Inflammatory diseases of the joints Rheumatoid arthritis or other inflammatory arthritis as diagnosed by American College of Rheumatology criteria Contraindication to hyalgan treatment Previous intraarticular fracture of a knee joint Infection or skin disease located at the place of injection and invasive procedures done to the knee joint within previous two months inclusive intra-articular injections of steroids. Any other condition that might interfere with the efficacy assessment or completion of the trial.

Sites / Locations

  • Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102

Outcomes

Primary Outcome Measures

Pain measured on a visual scale on movement (VAS-movement)
At rest (VAS-rest)
During the night (VAS-night)

Secondary Outcome Measures

KOOS scores (knee injury and osteoarthritis outcome score)
Daily consumption of analgetics
Cartilage and bone degradation markers
The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
Global assessment patient
Global assessment investigator

Full Information

First Posted
September 2, 2005
Last Updated
September 2, 2005
Sponsor
Glostrup University Hospital, Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT00144820
Brief Title
Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
Official Title
Intra-Articular Injections of Hyaluronan Versus 20 Ml NaCl Versus Placebo in Treatment of Knee Osteoarthritis: a Randomised, Double-Blind, Placebo Controlled Single Centre Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

5. Study Description

Brief Summary
251 consecutive patients with knee arthrosis were randomized to one of three interventions: Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate (hyaluronan) or 20 ml isotonic saline (excessive saline). They all suffered from clinically and radiologically verified arthrosis of the knee with daily pain that did not respond to treatment with analgetics. Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and cartilage degradation were measured in urine/blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Hyaluronan, Gonarthrosis, Osteoarthritis,knee, Double-blinded, Placebo controlled, Randomised

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
251 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Injection of Hyaluronan or Saline
Primary Outcome Measure Information:
Title
Pain measured on a visual scale on movement (VAS-movement)
Title
At rest (VAS-rest)
Title
During the night (VAS-night)
Secondary Outcome Measure Information:
Title
KOOS scores (knee injury and osteoarthritis outcome score)
Title
Daily consumption of analgetics
Title
Cartilage and bone degradation markers
Title
The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
Title
Global assessment patient
Title
Global assessment investigator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients, men/women age > 60 years with clinical, Radiological and possible arthroscopical verified knee osteoarthritis. Knee pain on the day of examination scoring more than 20 mm on a visual analogue scale (VAS) at baseline. Exclusion Criteria: Age below 60 Unconsciousness Psychosis Demens Ingestion of drugs that may influence the results of the clinical examinations Inflammatory diseases of the joints Rheumatoid arthritis or other inflammatory arthritis as diagnosed by American College of Rheumatology criteria Contraindication to hyalgan treatment Previous intraarticular fracture of a knee joint Infection or skin disease located at the place of injection and invasive procedures done to the knee joint within previous two months inclusive intra-articular injections of steroids. Any other condition that might interfere with the efficacy assessment or completion of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Lundsgaard, MD
Organizational Affiliation
Copenhagen Trial Unit (CTU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
City
Copenhagen
State/Province
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18415773
Citation
Lundsgaard C, Dufour N, Fallentin E, Winkel P, Gluud C. Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial. Scand J Rheumatol. 2008 Mar-Apr;37(2):142-50. doi: 10.1080/03009740701813103.
Results Reference
derived

Learn more about this trial

Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

We'll reach out to this number within 24 hrs