EUCTR2014-003412-37-GB进行中（未招募）1 期
Improving outcomes for patients with hip osteoarthritis: a randomised controlled trial - Hip Injection Trial (HIT)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 348
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
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