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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
V00220 IA 402
Study information
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
Acronym
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
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
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
30
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
Erasme Hospital Ethics Committee
Brussels
1070
Belgium
Sponsor information
Organisation
Pierre Fabre Research Institute [Institut de Recherche Pierre Fabre] (France)
Sponsor details
3 Avenue Hubert Curien
Toulouse
31035
France
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Industry
Funder name
Pierre Fabre Research Institute (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/08/2012 | Yes | No |