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ISRCTN
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ISRCTN86638547
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ClinicalTrials.gov identifier
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Public title
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Efficacy of intra-articular injection for end stage hip osteoarthritis: can pain and disability be relieved?
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Scientific title
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Acronym
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N/A
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Serial number at source
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NT/41/04/JC
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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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.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Hip osteoarthritis
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Participants - inclusion criteria
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1. Age >/=50 years
2. Primary hip osteoarthritis
3. Listed for Total Hip Replacement (THR)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2005
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Anticipated end date
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01/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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160
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Interventions
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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)
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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1. Euroqol EQ-5D
2. Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI)
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Sources of funding
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1. Northumbria Healthcare NHS Trust
2. NT/41/04/JC - an 'own account' trial, funded via the NHS R&D Support Funding stream
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Trial website
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Publications
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Contact name
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Dr
Fraser
Birrell
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Address
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Institute of Cellular Medicine
Musculoskeletal Research Group
4th Floor Catherine Cookson Building
The Medical School
Framlington Place
Newcastle University
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City/town
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Newcastle
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Zip/Postcode
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NE2 4HH
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Country
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United Kingdom
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Tel
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+44 (0)191 222 5548
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Fax
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+44 (0)191 222 5455
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Email
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fraser.birrell@ncl.ac.uk
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Sponsor
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Northumbria Healthcare NHS Trust (UK)
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Address
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North Tyneside General Hospital
Rake lane
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City/town
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North Shields
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Zip/Postcode
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NE29 8NH
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Country
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United Kingdom
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Date applied
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08/07/2005
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Last edited
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28/10/2010
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Date ISRCTN assigned
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10/02/2006
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