Osteoarthritis, KneePhase 4NCT00144820
Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
A Phase 4 study testing Injection of Hyaluronan or Saline in people with Osteoarthritis, Knee, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Injection of Hyaluronan or Saline
- Type of treatment
- Injection or infusion
- How many people
- 251 participants
- Where
- 1 siteDenmark
- Study dates
- May 1999to Nov 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age below 60
- Unconsciousness
- Psychosis
- Demens
- Ingestion of drugs that may influence the results of the clinical examinations
- Inflammatory diseases of the joints
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
Copenhagen, Copenhagen Ø, 2100
About this study
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.
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Injection of Hyaluronan or Saline
- Keywords
- Hyaluronan, Gonarthrosis, Osteoarthritis,knee, Double-blinded, Placebo controlled, Randomised
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Hyaluronan or SalineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured on a visual scale on movement (VAS-movement)
At rest (VAS-rest)
During the night (VAS-night)
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMay 1999
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 251 participants
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte Lundsgaard, MD, Principal investigator, Copenhagen Trial Unit (CTU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144820
- Sponsor's protocol ID
- KA 99005gs
- Status last verified
- Aug 2005
- First submitted
- 2 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Publications
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.
PubMed 18415773
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00144820
- Acronym / sponsor ID
- KA 99005gs
- Conditions
- Osteoarthritis, Knee
- Keywords
- Hyaluronan, Gonarthrosis, Osteoarthritis,knee, Double-blinded, Placebo controlled, Randomised
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 251 participants
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 1999
- Study completion
- Nov 2001
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Age below 60
- Unconsciousness
- Psychosis
- Demens
- Ingestion of drugs that may influence the results of the clinical examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of Hyaluronan or Saline | Drug | – |
Primary outcome
Pain measured on a visual scale on movement (VAS-movement)
At rest (VAS-rest)
During the night (VAS-night)
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2005.
- Derived from this study: PubMed 18415773Lundsgaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Lundsgaard, MD principal investigator
Copenhagen Trial Unit (CTU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injection of Hyaluronan or Saline in people with Osteoarthritis, Knee, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured on a visual scale on movement (VAS-movement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2005.