Condition category
Musculoskeletal Diseases
Date applied
08/07/2005
Date assigned
10/02/2006
Last edited
01/10/2013
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 Fraser Birrell

ORCID ID

Contact details

Institute of Cellular Medicine
Musculoskeletal Research Group
4th Floor Catherine Cookson Building
The Medical School
Framlington Place
Newcastle University
Newcastle
NE2 4HH
United Kingdom
+44 (0)191 222 5548
fraser.birrell@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NT/41/04/JC

Study information

Scientific title

Acronym

Study hypothesis

Intra-articular injection of either steroids or Hyaluronic Acid (HA) are now being recommended for patients with knee OsteoArthritis (OA), but there is a lack of studies in hip OA to demonstrate its safety and efficacy. Due to lack of adequate guidance, the lack of response in early research may reflect poor accuracy of injection, rather than lack of benefit.
This study, using an injection technique proven to be accurate, will aim to demonstrate the duration of objective improvement in pain, disability (function and patient’s global health assessment) and objective mobility in patients with end stage hip osteoarthritis with ultrasound guided hip injection compared to standard care.

Ethics approval

Ethical approval was initially obtained [2002] from the Northumberland Ethics committee with revisions to the protocol being approved in Aug 2005, reference number: NLREC 54/2002.
Subsequently, approval was also obtained from Newcastle/North Tyneside Committee in Aug 2005, reference number: NNT SSA 05/Q0905/155.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hip osteoarthritis

Intervention

The study is a prospective, randomised, blind, controlled (three arm) trial, with a further randomised standard care arm. The four groups are:

1. Standard care (no injection)
2. Standard care and injection of 3 ml normal saline
3. Standard care and injection of 3 ml steroid (depomedrone 120 mg)
4. Standard care and injection of 3 ml durolane (injection will be performed under local anaesthetic with ultrasound guidance)

Intervention type

Drug

Phase

Not Specified

Drug names

1. Depomedrone
2. Durolane

Primary outcome measures

1. Visual Analogue Scale (VAS) for global pain
2. Pain and function scales of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3. Numact (objective activity monitor)

Secondary outcome measures

1. Euroqol EQ-5D
2. Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI)

Overall trial start date

01/08/2005

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >/=50 years
2. Primary hip osteoarthritis
3. Listed for Total Hip Replacement (THR)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Secondary hip OA
2. Collapse of femoral head on anteroposterior pelvic radiograph
3. Listed for bilateral THR
4. Co-morbid conditions resulting in gross lower limb asymmetry (e.g. stroke, amputees, severe leg shortening)
5. Inability to communicate in verbal or written English

Recruitment start date

01/08/2005

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cellular Medicine
Newcastle
NE2 4HH
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Trust (UK)

Sponsor details

North Tyneside General Hospital
Rake lane
North Shields
NE29 8NH
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Northumbria Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NT/41/04/JC - an 'own account' trial, funded via the NHS R&D Support Funding stream

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/21068096

Publication citations

  1. Results

    Atchia I, Kane D, Reed MR, Isaacs JD, Birrell F, Efficacy of a single ultrasound-guided injection for the treatment of hip osteoarthritis., Ann. Rheum. Dis., 2011, 70, 1, 110-116, doi: 10.1136/ard.2009.127183.

Additional files

Editorial Notes