Contact information
Type
Scientific
Primary contact
Mr Peter Ward
ORCID ID
Contact details
Consultant in Orthopaedics
Dorset County Hospital
Dorchester
DT1 2JY
United Kingdom
Peter.Ward@dchft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intraarticular injections for hip osteoarthritis: Steroid versus Hyaluronic acid: a randomised controlled trial
Acronym
Study hypothesis
Intraarticular hyaluronic acid injections are better than steroid injections for treatment of hip osteoarthritis.
25/06/2013: Please note that this trial was stopped in March 2012
Added 11/07/2013: NRES research summary: http://www.nres.nhs.uk/researchsummaries/?entryid29=151798
Ethics approval
Added 11/07/2013: NRES Committee London - Central, 18/11/2009, 09/H0718/52
Study design
Prospective randomised single-blind single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hip osteoarthritis
Intervention
The participants will be randomly allocated to the following two groups:
Group 1: Kenalog® (triamcinolone) 80 mg intraarticular injection into hip joint, used once on Day 1.
Group 2: Hyaluronic acid 2 ml intraarticular injection into hip joint, used once on Day 1.
Intervention type
Drug
Phase
Not Applicable
Drug names
Triamcinolone (steroid), hyaluronic acid
Primary outcome measures
The following will be assessed at 6 weeks, 3 and 6 months:
1. Visual Analogue Scale (VAS) for pain
2. Oxford hip score for function
Secondary outcome measures
1. Duration of pain relief
2. Any complications, followed-up for 6 months
Overall trial start date
01/07/2009
Overall trial end date
31/12/2010
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
1. Clinical and radiological diagnosis of osteoarthritis (primary or secondary)
2. Both males and females, age over 16 years
3. Ability to understand the process and consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110 (55 in each arm)
Participant exclusion criteria
1. Presence of any active infection elsewhere
2. History of previous hip joint infection
3. Patients with a diagnosis of avascular necrosis of femoral head
4. Rheumatoid arthritis
5. Underlying joint replacement
Recruitment start date
01/07/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant in Orthopaedics
Dorchester
DT1 2JY
United Kingdom
Sponsor information
Organisation
Dorset County Hospital NHS Foundation Trust (UK)
Sponsor details
Dorset County Hospital
Dorchester
DT1 2JY
United Kingdom
+44 (0)1305 251150
Peter.ward@dchft.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Dorset County Hospital NHS foundation Trust (UK)
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