Condition category
Musculoskeletal Diseases
Date applied
30/04/2009
Date assigned
11/05/2009
Last edited
11/07/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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: KenalogĀ® (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

http://www.dchft.nhs.uk/

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

Publication citations

Additional files

Editorial Notes