Intra-articular injection of hyaluronic acid (MW 1500-2000 KDa; HyalOne®) in symptomatic osteoarthritis of the hip

ISRCTN	ISRCTN32694665
DOI	https://doi.org/10.1186/ISRCTN32694665
Secondary identifying numbers	Q47_09_01

Submission date: 11/05/2010
Registration date: 20/05/2010
Last edited: 08/08/2013

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

Not provided at time of registration

Contact information

Dr Nicola Giordan
Scientific

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

Study information

Study design	Prospective cohort study
Primary study design	Interventional
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Intra-articular injection of hyaluronic acid (MW 1500-2000 KDa; HyalOne®) in symptomatic osteoarthritis of the hip: a prospective cohort study
Study hypothesis	The aim of the study is to appraise rate and incidence of total hip replacement (THR) in patients suffering from hip osteoarthritis (OA), treated with ultrasound-guided intra-articular injections of Hyalubrix®.
Ethics approval(s)	Bioethics Committee of the Roman Province of Fatebenefratelli (Comitato di Bioetica della Provincia Romana dei FBF) approved on the 13/10/2008 (ref: 61/2008/C.B.)
Condition	Patients suffering from hip osteoarthritis
Intervention	Ultrasound-guided intra-articular injections of hyaluronic acid (MW 1500-2000 KDa) Injections were performed at least every 6 months, but some patients were treated as often as every 3 months. The study follow-up visits were performed every 3 months.
Intervention type	Other
Primary outcome measure	Changes from baseline to the final visit with respect to Lequesne index
Secondary outcome measures	1. Changes from baseline to the final visit with respect to 1.1. Visual Analogue Scale (VAS) 1.2. Non-steroidal anti-inflammatory drug (NSAID) intake 2. Assessment of predictive indices for the response variables (lequesne and VAS indexes)
Overall study start date	13/10/2008
Overall study end date	13/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	304
Participant inclusion criteria	1. Age > 40 years 2. Hip OA with joint pain of at least one years duration 2.1. Symptomatic hip OA according to the American College of Rheumatology (ACR) 2.2. Grade I, II, III or IV hip OA according to the Kellgren-Lawrence classification 2.3. Evaluated on an X-ray taken no more than two months before enrolment
Participant exclusion criteria	1. Concomitant use of oral anticoagulant therapy 2. Severe reduction of joint space narrowing evident on X-ray 3. Significant co-morbidities, hypersensitivity to HA or to avian proteins 4. Chronic systemic steroid treatment
Recruitment start date	13/10/2008
Recruitment end date	13/12/2009

Locations

Countries of recruitment

Italy

Study participating centre

Via Ponte della Fabbrica 3/A

Abano Terme
35031
Italy

Sponsor information

Fidia Farmaceutici S.p.A (Italy)
Industry

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

"ROR"	https://ror.org/00dy5wm60

Funders

Funder type

Industry

Fidia Farmaceutici S.p.A (Italy)

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	01/12/2011		Yes	No