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
Protocol serial number	Q47_09_01
Sponsor	Fidia Farmaceutici S.p.A (Italy)
Funder	Fidia Farmaceutici S.p.A (Italy)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Nicola Giordan
Scientific

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

Primary study design	Interventional
Study design	Prospective cohort study
Secondary study design	Cohort study
Study type	Participant 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 objectives	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.)
Health condition(s) or problem(s) studied	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(s)	Changes from baseline to the final visit with respect to Lequesne index
Key secondary outcome measure(s)	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)
Completion date	13/12/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	304
Key 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
Key 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
Date of first enrolment	13/10/2008
Date of final enrolment	13/12/2009

Via Ponte della Fabbrica 3/A

Abano Terme
35031
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes