NCT03063099已完成不适用
A Pilot Study of ReNu™ Hip Injection: Monitoring the Response of Hip Function and Pain in Patient With Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- IHOT12 - International Hip Outcome Tool 12
研究概览
简要总结
A pilot study to evaluate changes in hip function and pain in patients with osteoarthritis receiving the ReNu™ Hip Injection.
详细描述
This is a prospective, non-randomized pilot study evaluating the efficacy of ReNu™ hip injection on patients with moderate osteoarthritis. The effects will be measured primarily through patient-reported outcomes questionnaires after a single injection. Patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate hip osteoarthritis determined by a combination of clinical and radiographic findings
- •Radiographic findings consistent with osteoarthritis as documented by Tonnis radiographic classification (Grade 1 or 2)
- •Grade 1 Tonnis changes are defined as mild and include increased sclerosis, slight narrowing of the joint space, no or slight loss of head sphericity
- •Grade 2 Tonnis changes are defined as moderate and include small cysts, moderate narrowing of the joint space, moderate loss of head sphericity
- •Patients with bilateral grade 1or 2 Tonnis hip osteoarthritis who have bilateral symptoms may have their more symptomatic hip injected. If equivalent symptoms are reported by the patient, then the patient will choose which hip is to be injected. The other Hip can be treated with all standard local interventions that will not have a prolonged systemic effect that could affect the study hip (for example steroid injection, cold therapy, soft braces).
- •Between the Ages 18 to 70 with minimum activity level of 2 on the Tegner scale.
- •BMI less than 40
- •Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal
排除标准
- •Pain medication (including NSAIDs) less than 15 days before injection (may take acetaminophen)
- •Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index hip
- •Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion
- •History of substance abuse.
- •Failure to agree NOT to take additional hip symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team
- •Pregnancy or desire to become pregnant during study duration
- •Corticosteroid injection into the index hip within 6 months
- •Viscosupplement injection into the index hip within 6 months
- •Previous open or arthroscopic hip surgery of the involved index hip within the previous 6 months
- •Open or arthroscopic surgery of the contralateral hip within the last 6 months
- •Worker compensation
- •Acute index hip injury (injury within 3 months)
- •History of Diabetes mellitus
- •History of solid organ or hematologic transplantation
- •History of rheumatoid arthritis or other autoimmune disorder
- •Diagnosis of a non-basal cell malignancy within the preceding 5 years
- •Infection requiring antibiotic treatment within the preceding 3 months
- •Current therapy with any immunosuppressive medication, including corticosteroids at a dose > 5 mg per day
结局指标
主要结局
IHOT12 - International Hip Outcome Tool 12
时间窗: 3 & 6 months
Change from Baseline
Visual Analog Scale (VAS) Pain Scale
时间窗: 3 & 6 months
Change from Baseline
次要结局
- Modified Harris Hip Score(3, 6 & 12 months)
- SF12 Score(3, 6 & 12 months)
- Single Assessment Numerical Evaluation (SANE)(3, 6 & 12 months)
研究者
研究点 (4)
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