Intra-articular hyaluronic acid and chondroitin sulfate in osteoarthritis of the knee
| ISRCTN | ISRCTN91883031 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91883031 |
| Secondary identifying numbers | V00220 IA 402 |
- Submission date
- 16/12/2011
- Registration date
- 04/04/2012
- Last edited
- 13/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff. In the treatment of osteoarthritis, it is now agreed that surgical procedures should be at least delayed, and even avoided as far as possible. Hyaluronic acid is found in the synovial fluid in joints and acts as both a lubricant and shock absorber. Hyaluronic acid can be injected into the joint (intra-articular injections) to improve joint lubrication. Structovial CS is the only one of the currently available solutions to treat knee osteoarthritis that combines chondroitin sulphate and hyaluronic acid (HA/CS). Chondroitin sulfate is a chemical that is normally found in cartilage around joints in the body. The aim of this study is to assess the effectiveness of three weekly intra-articular injections of HA/CS in knees affected by osteoarthritis.
Who can participate?
Patients aged between 45 and 80 with osteoarthritis of the knee
What does the study involve?
All participants receive three intra-articular injections of HA/CS over a 3-week period. Pain and knee function are assessed over a period of 12 weeks.
What are the possible benefits and risks of participating?
HA/CS may improve participants’ health and physical function. There are no known risks to participants.
Where is the study run from?
The study takes place at various rheumatological clinics at hospitals and at private centres in France and Belgium
When is the study starting and how long is it expected to run for?
March to October 2008
Who is funding the study?
Pierre Fabre Research Institute (France)
Who is the main contact?
Prof. Thierry Appelboom
Contact information
Scientific
Erasme Hospital Ethics Committee
University Libre of Bruxelles
[Le Comite dEthique Hopital Erasme]
808 Route de Lennik
Brussels
1070
Belgium
Study information
| Study design | Single-center open-label phase IV study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study hypothesis | Evaluate the efficacy of three weekly intra-articular injections of hyaluronic acid/chondroitin sulfate in knees affected by femoro-tibial osteoarthritis over a period of 12 weeks |
| Ethics approval(s) | Erasme Hospital Ethics Committee, University Libre of Bruxelles, Belgium [Le Comite dEthique Hopital Erasme], 20/12/2007 |
| Condition | Osteoarthritis of the knee |
| Intervention | Three weekly intra-articular injections of HA/CS in knees affected by femoro-tibial osteoarthritis over a 3 week period |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Chondroitin sulphate, hyaluronic acid |
| Primary outcome measure | Pain (VAS) and function (Lequesnes Algo-Functional Knee Index) over a period of 12 weeks |
| Secondary outcome measures | 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] |
| Overall study start date | 10/03/2008 |
| Overall study end date | 13/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Participant 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. Patients written informed consent |
| Participant 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) |
| Recruitment start date | 10/03/2008 |
| Recruitment end date | 13/10/2008 |
Locations
Countries of recruitment
- Belgium
Study participating centre
1070
Belgium
Sponsor information
Research organisation
3 Avenue Hubert Curien
Toulouse
31035
France
| Website | http://www.pierre-fabre.com/ |
|---|---|
"ROR" |
https://ror.org/04hdhz511 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/08/2012 | Yes | No |
Editorial Notes
13/10/2016: Plain English summary added.
