Efficacy of intra-articular injection for end stage hip osteoarthritis: can pain and disability be relieved?

ISRCTN	ISRCTN86638547
DOI	https://doi.org/10.1186/ISRCTN86638547
Secondary identifying numbers	NT/41/04/JC

Submission date: 08/07/2005
Registration date: 10/02/2006
Last edited: 01/10/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Fraser Birrell
Scientific

Institute of Cellular Medicine
Musculoskeletal Research Group
4th Floor Catherine Cookson Building
The Medical School
Framlington Place
Newcastle University
Newcastle
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 5548
Email	fraser.birrell@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
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 patients global health assessment) and objective mobility in patients with end stage hip osteoarthritis with ultrasound guided hip injection compared to standard care.
Ethics approval(s)	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.
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	1. Depomedrone 2. Durolane
Primary outcome measure	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 study start date	01/08/2005
Overall study end date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	160
Participant inclusion criteria	1. Age >/=50 years 2. Primary hip osteoarthritis 3. Listed for Total Hip Replacement (THR)
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

England
United Kingdom

Study participating centre

Institute of Cellular Medicine

Newcastle
NE2 4HH
United Kingdom

Sponsor information

Northumbria Healthcare NHS Trust (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/01gfeyd95

Funders

Funder type

Government

Northumbria Healthcare NHS Trust

No information available

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

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?
Results article	results	01/01/2011		Yes	No