Intra-articular hyaluronic acid and chondroitin sulfate in osteoarthritis of the knee

ISRCTN	ISRCTN91883031
DOI	https://doi.org/10.1186/ISRCTN91883031
Protocol serial number	V00220 IA 402
Sponsor	Pierre Fabre Research Institute [Institut de Recherche Pierre Fabre] (France)
Funder	Pierre Fabre Research Institute (France)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Prof Thierry Appelboom
Scientific

Erasme Hospital Ethics Committee
University Libre of Bruxelles
[Le Comite dEthique Hopital Erasme]
808 Route de Lennik
Brussels
1070
Belgium

Study information

Primary study design	Interventional
Study design	Single-center open-label phase IV study
Secondary study design	Non randomised study
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Chondroitin sulphate, hyaluronic acid
Primary outcome measure(s)	Pain (VAS) and function (Lequesnes Algo-Functional Knee Index) over a period of 12 weeks
Key secondary outcome measure(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]
Completion date	13/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key 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
Key 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)
Date of first enrolment	10/03/2008
Date of final enrolment	13/10/2008

Locations

Countries of recruitment

Belgium

Study participating centre

Erasme Hospital Ethics Committee

Brussels
1070
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/10/2016: Plain English summary added.