How Effective are Topical NSAIDs in the Treatment of Hip Osteoarthritis: An In Vivo Study in Patients Undergoing Total Hip Arthroplasty.
Phase 1
- Conditions
- Osteoarthritis of the hipMedDRA version: 19.1Level: LLTClassification code 10031167Term: Osteoarthritis NOSSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-000178-13-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
1. Listed for total hip replacement for osteoarthritis
2. Aged 18 - 95 years
3. Able to consent to the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Exclusion Criteria
1. Allergy to NSAIDs
2. Known contraindications to NSAIDs eg asthma, peptic ulcer disease, renal impairment
3. Pregnancy
4. History of skin sensitivity to topical agents
5. Pre-existing skin disease at site of application, eg psoriasis, eczema
6. Inability to comply with regular application of the gel
7. Unable to provide informed consent due to insufficient English
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does the application of a topical NSAID preparation penetrate the hip joint?;Secondary Objective: None;Primary end point(s): Concentration of diclofenac within synovium and synovial fluid.;Timepoint(s) of evaluation of this end point: Analysis will be commenced by the Centre for Forensic Science at Bournemouth University on day of surgery once samples have been collected.
- Secondary Outcome Measures
Name Time Method