Condition category
Musculoskeletal Diseases
Date applied
16/12/2011
Date assigned
04/04/2012
Last edited
13/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thierry Appelboom

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

Erasme Hospital Ethics Committee, University Libre of Bruxelles, Belgium [Le Comite d’Ethique Hopital Erasme], 20/12/2007

Study design

Single-center open-label phase IV study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial 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

Phase

Phase IV

Drug names

Chondroitin sulphate, hyaluronic acid

Primary outcome measures

Pain (VAS) and function (Lequesne’s 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 trial start date

10/03/2008

Overall trial end date

13/10/2008

Reason abandoned

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. Patient’s written informed consent

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://www.pierre-fabre.com/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22862789

Publication citations

  1. Results

    Henrotin Y, Hauzeur JP, Bruel P, Appelboom T, Intra-articular use of a medical device composed of hyaluronic acid and chondroitin sulfate (Structovial CS): effects on clinical, ultrasonographic and biological parameters., BMC Res Notes, 2012, 5, 407, doi: 10.1186/1756-0500-5-407.

Additional files

Editorial Notes

13/10/2016: Plain English summary added.