Aspirin (Acetylsalicylic Acid) in the Prevention of Collapse of the Femoral Head in Early-stage Non-traumatic Osteonecrosis: a Two-year Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Evaluation of radiologic progression of osteonecrosis
研究概览
简要总结
The purpose of this study is to determine if prolonged administration of low-dose aspirin will prevent the progression of early-stage osteonecrosis of the femoral head and may even reduce the extent of involvement of the femoral head by the necrotic process The design is intended to be parallel group where a total of 114 patients will be randomized in a 1:1 ratio to the treatment (ASA) and the control (Placebo) arms.
详细描述
- TRIAL OBJECTIVES The primary objective of this study is to evaluate the radiologic progression of ONFH on either radiographs or MRI. A successful outcome is defined as no difference in ONFH staging according to the Ficat & Arlet or Steinberg classifications at last patient follow-up compared to initial radiological staging. This translates into lack of progression over the course of the study while the natural evolution is progression over time.
The secondary objective is to evaluate the percentage of involvement of the femoral head on radiographs and/or MRI which measures the extent of the disease. We expect that the extent of the disease will be reduced at 2 years. 2. STUDY DESIGN AND DURATION This study is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that aims to test the efficacy of the proposed medical intervention (ASA). The design is intended to be parallel group where a total of 114 patients will be randomized in a 1:1 ratio to the treatment (ASA) and the control (Placebo) arms.
All patients presenting to the osteonecrosis clinic of one of the participating centres will be first evaluated by an orthopedic surgeon to confirm the diagnosis of early ONFH on at least one hip. Selected patients will be screened for eligibility according to specific inclusion and exclusion criteria.
Eligible patients who accept to participate in this study will be randomized to either a control arm (placebo) or a treatment arm (Aspirin). Recruited patient will take their assigned treatment daily at breakfast from enrolment and for a minimum of two years They will be followed over a period of 2 years. Evaluations will be taken at baseline and every 6 months (5 visits in total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to the objectives of the study, the identity of ASA and Placebo treatments will not be known to investigators, research staff, or patients. Access to the randomization code will be strictly controlled in order to ensure double-blind administration of study treatments. Packaging and labeling of ASA and Placebo treatments will be identical to maintain the blind.
All of the study drug profiles will be prepared in order to be identical in appearance to preserve the study blinding. The investigator and the subject, as well as all staff involved in the conduct or management of the study will be blinded to which treatment is assigned.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old
- •Patients with early osteonecrosis of the hip as defined above
- •Diagnosis confirmed within 3 months of the screening visit
- •Patients accept to take the study medication
排除标准
- •A history of hip trauma or surgery affecting the hip involved with early stage osteonecrosis as per criteria above
- •Concurrent use of anticoagulants
- •Concurrent use of bisphosphonates
- •Concurrent use of Aspirin for any reason
- •Patients with recent active severe peptic ulcer disease that are not on PPI.
- •Patients with advanced osteonecrosis of the hip with signs of collapse or end-stage joint arthritis of the hip that are immediately referred for surgical consultation for THA
- •Patients who are hypersensitive to ASA, salicylates, or non-steroidal anti-inflammatory drugs
- •Hepatic impairment (Bilirubin total, AST, ALT > 2-3x upper limit of normal), renal failure (creatinine level above normal with glomerular filtration rate < 45 ml/minute), or congestive heart failure
- •Platelets number should be more than 100,000 ( > 100 x 109 /L)
- •Pregnancy. If the patient is not sure whether she may be pregnant or not, a screening for pregnancy should be done.
研究组 & 干预措施
Aspirin
Aspirin 100 mg
1 tablet/ day for 2 years
干预措施: Aspirin (Drug)
Placebo
Placebo
1 tablet/ day for 2 years
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of radiologic progression of osteonecrosis
时间窗: 6 months
The primary endpoint is to evaluate the radiologic progression of ONFH by measuring the difference in ONFH staging according to the Ficat \& Arlet or Steinberg classifications at last patient follow-up compared to initial radiological staging.
次要结局
- Measure the percentage involvement of the femoral head on MRI.(6 months)
研究者
Chantal Seguin
Hematologist-oncologist
McGill University Health Centre/Research Institute of the McGill University Health Centre