Steroid versus hyaluronic acid injections for hip arthritis

ISRCTN	ISRCTN04950164
DOI	https://doi.org/10.1186/ISRCTN04950164
Secondary identifying numbers	N/A

Submission date: 30/04/2009
Registration date: 11/05/2009
Last edited: 11/07/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Peter Ward
Scientific

Consultant in Orthopaedics
Dorset County Hospital
Dorchester
DT1 2JY
United Kingdom

Email	Peter.Ward@dchft.nhs.uk

Study information

Study design	Prospective randomised single-blind single-centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Intraarticular injections for hip osteoarthritis: Steroid versus Hyaluronic acid: a randomised controlled trial
Study objectives	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(s)	Added 11/07/2013: NRES Committee London - Central, 18/11/2009, 09/H0718/52
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Triamcinolone (steroid), hyaluronic acid
Primary outcome measure	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 study start date	01/07/2009
Completion date	31/12/2010
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	110 (55 in each arm)
Key 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
Key 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
Date of first enrolment	01/07/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Consultant in Orthopaedics

Dorchester
DT1 2JY
United Kingdom

Sponsor information

Dorset County Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Dorset County Hospital
Dorchester
DT1 2JY
England
United Kingdom

Phone	+44 (0)1305 251150
Email	Peter.ward@dchft.nhs.uk
Website	http://www.dchft.nhs.uk/
"ROR"	https://ror.org/04nckd528

Funders

Funder type

Government

Dorset County Hospital NHS foundation Trust (UK)

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?
HRA research summary			28/06/2023	No	No