|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
7 November 2016 |
|
Main ID: |
ISRCTN91883031 |
|
Date of registration:
|
04/04/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Intra-articular hyaluronic acid and chondroitin sulfate in osteoarthritis of the knee
|
|
Scientific title:
|
Evaluation of a medical device comprising hyaluronic acid and chondroitin sulfate for intra-articular use in patients suffering from femorotibial osteoarthritis of the knee |
|
Date of first enrolment:
|
10/03/2008 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN91883031 |
|
Study type:
|
Interventional |
|
Study design:
|
Single-center open-label phase IV study (Treatment)
|
|
Phase:
|
Phase IV
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Thierry
Appelboom |
|
Address:
|
Erasme Hospital Ethics Committee
University Libre of Bruxelles
[Le Comite d?Ethique Hopital Erasme]
808 Route de Lennik
1070
Brussels
Belgium |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Male or female patients aged between 45 and and 80 years
2. Suffering from internal and/or external femoro tibial OA:
2.1. Meeting the criteria of the American College of Rheumatology (ACR)
2.2. Lasting for at least 6 months
2.3. Pain > = 40mm as measured on a visual analogue scale (VAS)
2.4. Stage Kellgren and Lawrence II or III
3. OA deemed to justify a treatment with intra articular HA according to the investigator
4. Patient?s written informed consent
Exclusion criteria: 1. Symptomatic femoro-patellar arthrosis or hip arthrosis on the same side, concomitant skeletal disease (Paget disease, rheumatoid arthritis, ankylosing spondylitis)
2. Former or concomitant treatment (intra-articular corticosteroids, topical or oral NSAIDs, anti-arthritis slow acting treatment, recent surgery)
3. Individual characteristics incompatible with a drug trial (pregnancy or lack of contraception, serious concomitant disease, participation in a clinical trial within the preceding 30 days)
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Osteoarthritis of the knee
Musculoskeletal Diseases
Gonarthrosis
|
|
Intervention(s)
|
Three weekly intra-articular injections of HA/CS in knees affected by femoro-tibial osteoarthritis
over a 3 week period
|
|
Primary Outcome(s)
|
|
Pain (VAS) and function (Lequesne?s Algo-Functional Knee Index) over a period of 12 weeks
|
|
Secondary Outcome(s)
|
1. Ultrasound parameters (joint effusion, synovial and popliteal cysts)
2. OA biomarkers of inflammation [IL-6], degradation [Coll2-1] and synthesis [CPII] of collagen type II, degradation of aggrecan [CS846], and markers of oxidative stress [Coll2-1NO2]
|
|
Secondary ID(s)
|
|
V00220 IA 402
|
|
Source(s) of Monetary Support
|
|
Pierre Fabre Research Institute (France)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|