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Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

NCT00144820 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2005-09-05

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Injection of Hyaluronan or Saline

Sponsors & Collaborators

  • Glostrup University Hospital, Copenhagen

    lead OTHER

Principal Investigators

  • Charlotte Lundsgaard, MD · Copenhagen Trial Unit (CTU)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31
Completion
2001-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00144820 on ClinicalTrials.gov