How Effective are Topical NSAIDs in the Treatment of Hip Osteoarthritis: An In Vivo Study in Patients Undergoing Total Hip Arthroplasty.

How Effective are Topical NSAIDs in the Treatment of Hip Osteoarthritis: An In Vivo Study in Patients Undergoing Total Hip Arthroplasty - TOPHIP: Topical NSAIDs in the Treatment of Hip Osteoarthritis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000178-13-GB

Enrollment

Registered

2017-02-23

Start date

2017-04-13

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the hip MedDRA version: 19.1 Level: LLT Classification code 10031167 Term: Osteoarthritis NOS System Organ Class: 100000004859

Interventions

Trade Name: Voltarol 1.16% Emulgel Product Name: Voltarol 1.16% Emulgel Pharmaceutical Form: Gel INN or Proposed INN: Diclofenac diethylammonium CAS Number: 15307-86-5 Concentration unit: % percent C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

United Kingdom

Contacts

Public ContactStudy co-ordinator

Bournemouth University

timmins@bournemouth.ac.uk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026