Hip Injection Trial (HIT)

Phase 1

• Conditions: Hip osteoarthritis; MedDRA version: 21.1 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-003412-37-GB
• Lead Sponsor: Keele University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 348

Inclusion Criteria

1. Male or female aged = 40 years
2. A clinical diagnosis of unilateral or bilateral hip OA, and confirmed on plain radiography within the last 2 years, as made by a trained clinician in the musculoskeletal service
3. Moderate to severe current hip pain (a score of 4 or more on a 0-10 numeric rating scale)
4. Symptom duration of episode of at least 6 weeks
5. Hip pain occuring on most days of the last month
6. Informed written consent provided by the patient
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 116
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 232

Exclusion Criteria

Participants with the following characteristics are ineligible for the trial:
1. Hip pain due to other disorders (e.g. trochanteric bursitis, avascular necrosis, pain referred from back)
2. Intra-articular corticosteroid injection into the affected hip or ipsilateral trochanteric bursa injection within the proceding 3 months
3. Any previous surgery on the affected hip
4. Clinical suspicion of local or systemic sepsis or infection
5. Current or previous infection of the affected hip
6. Significant trauma to the affected hip requiring immobilisation in the previous 3 months
7. Unwillingness to undergo study interventions
8. Unable to understand and complete self report questionnaires written (or spoken) in English
9. Significant illness (known or suspected) including, but not limited to:
- inflammatory joint disease (e.g rheumatoid arthritis, seronegative spondyloarthropathy (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory-bowel disease associated with inflammatory arthritis))
- polymyalgia rheumatica or other condition requiring regular oral steroid use
- malignancy (where malignancy is thought to be causing hip pain eg. suspected bony metastases)
- any other severe medical illness which in the opinion of the local principal investigator (or other authorised clinical delegate) precludes trial participation
10. Pregnant or lactating females
11. Receiving anticoagulants (warfarin, dabigatran, rivaroxaban, low molecular weight heparin or apixaban)
12. Any history of hypersensitivity to triamcinolone acetonide or 1% lidocaine hydrochloride or any of their excipients (1N Hydrochloric Acid QS, 1N Sodium Hydroxide QS, Benzyl alcohol. Polysorbate 80, Sodium carboxymethylcellulose and Sodium chloride).
13. Contraindications to use of local anasesthetic: Complete heart block and hypovolaemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified