ISRCTN ISRCTN04950164
DOI https://doi.org/10.1186/ISRCTN04950164
Protocol serial number N/A
Sponsor Dorset County Hospital NHS Foundation Trust (UK)
Funder Dorset County Hospital NHS foundation Trust (UK)
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

Primary study designInterventional
Study designProspective randomised single-blind single-centre study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleIntraarticular injections for hip osteoarthritis: Steroid versus Hyaluronic acid: a randomised controlled trial
Study objectivesIntraarticular 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) studiedHip osteoarthritis
InterventionThe 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Triamcinolone (steroid), hyaluronic acid
Primary outcome measure(s)

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

Key secondary outcome measure(s)

1. Duration of pain relief
2. Any complications, followed-up for 6 months

Completion date31/12/2010
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration110
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Consultant in Orthopaedics
Dorchester
DT1 2JY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes