Condition category
Musculoskeletal Diseases
Date applied
11/05/2010
Date assigned
20/05/2010
Last edited
08/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicola Giordan

ORCID ID

Contact details

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Q47_09_01

Study information

Scientific title

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

Acronym

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

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.)

Study design

Prospective cohort study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

13/10/2008

Overall trial end date

13/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 40 years
2. Hip OA with joint pain of at least one year’s 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

304

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

Trial participating centre

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

Sponsor information

Organisation

Fidia Farmaceutici S.p.A (Italy)

Sponsor details

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Fidia Farmaceutici S.p.A (Italy)

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21814776

Publication citations

  1. Results

    Migliore A, Alberto M, Massafra U, Umberto M, Bizzi E, Emanuele B, Lagana B, Bruno L, Germano V, Valentina G, Piscitelli P, Prisco P, Granata M, Mauro G, Tormenta S, Sandro T, Intra-articular injection of hyaluronic acid (MW 1,500-2,000 kDa; HyalOne) in symptomatic osteoarthritis of the hip: a prospective cohort study., Arch Orthop Trauma Surg, 2011, 131, 12, 1677-1685, doi: 10.1007/s00402-011-1353-y.

Additional files

Editorial Notes