The Use of Bone Marrow Aspirate Concentrate in the Context of Hip Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Functional Benefit and Pain Level Changes using iHOT33 Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate the effect of combined Bone marrow aspirate concentrate (BMAC) and Platelet Rich Plasma (PRP) action after a single hip intraarticular injection to young symptomatic patients with primary radiologic stage of hip OA (Kellgren-Lawrence grade I or II) compared to a control local anesthetic with cortisone injection group of patients. The hypothesis is that the patients with hip OA will benefit more and for longer from OA symptoms in the BMAC and PRP group rather than in the group of local anaesthetic and cortisone. Furthermore, this study could be valuable in determining the safety and effectiveness of the BMAC and PRP combined injection for early low grade hip OA in young active patients who are neither good candidates for total hip replacement nor preservative hip surgery.
详细描述
The protocol will be applied to a blinded randomized controlled study. Patients who fit the inclusion criteria and have consented to the trial, will be randomized to receive a single injection of BMAC with PRP or local anesthetic with cortisone.
Pre-Injection Procedures:
Patients will receive a clinical evaluation where they will complete the HHS, the WOMAC score, the VR-12 form, VAS score, and the two functional assessment tests to assess pain and function prior to the injection. The two functional assessments will be performed by the blinded researcher. Following the evaluation, the patients will receive an intra-articular hip injection.
Injection Procedures:
Control group: In the second group of patients, an intraarticular injection of 1cm3 with 80mg of methylprednisolone combined with 3cm3 of 0.25% bupivacaine will be performed in the same manner with the first group.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to the intervention
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age <60 years old
- •BMI of <40 kg/m2
- •Able to walk 50m unaided and not confined to a wheel chair
- •Unilateral hip pain and radiographically and arthroscopically verified OA of the hip within the last 6 months (Kellgren-Lawrence grade I or II)
- •HHS of less than 80
- •Ability to understand the informed consent and participation instructions Attempted to use over the counter therapy without relief
- •Able to participate for the entire protocol study period
- •Able to follow physicians directions
排除标准
- •Clinically significant OA in the contralateral hip
- •Clinically significant pain in any other joint
- •Have had intra-articular BMAC and or PRP injection within the preceding six months in the study hip
- •Have had intra-articular steroid injection within the preceding three months in the study hip
- •Have had previous surgical procedures on the affected hip within the preceding 6 months
- •Have had a serious injury to the study hip within the previous 3 months
- •Have had a serious psychological or medical condition that would interfere with their involvement
- •Have had treatment with pain medications other than Tylenol and the drug remains in their system at the baseline or first study visit
- •Have used of opioids other than weak opioids for OA pain more than 3 days/week within the last month
- •Have used of systemic glucocorticoids (excluding inhaled steroids) within the preceding 3 months
- •Treatment started with glucosamine/chondroitin sulfate or if the dosing has not been stable in the previous three months
- •Has had a history of septic arthritis, skin infection or disease in the region of the injection site
- •Currently using an anticoagulant excluding Aspirin 325 mg/day
- •Uncontrolled diabetes
- •Has any medical condition the principal investigator believes deems the patient unsuitable for the study
- •Has any pathology of lumbar spine, sacroiliac (SI) joints, neuropathic or extra-articular hip pain
- •Has a history of alcohol or drug abuse within the six months prior to enrolment in the study
- •Has had a diagnosis of rheumatoid arthritis
- •Has had a diagnosis of ankylosing spondylitis
- •Has had a diagnosis of psoriatic arthritis
- •Has had a diagnosis of reactive arthritis
- •Has had a diagnosis of gout
- •Has had a diagnosis of any connective tissue disease.
结局指标
主要结局
Functional Benefit and Pain Level Changes using iHOT33 Questionnaire
时间窗: 6 months
Assessment of functional benefit and pain level changes, using the International Hip Outcome Tool (iHot33) score at the 6-month time point post-injection, as well as, the pre-injection iHot33 score. The iHOT33 is a 33 question tool used to assess a patients ability to return to an active lifestyle through a subjective measurement of symptoms as well as emotional and social health status. Patients use a visual analog type scale (VAS) for each of the 33 questions to determine if activities are extremely difficult (to the left) to not difficult at all (to the right). Score is calculated as a mean on all VAS scores measured in millimeters, with 100 being the best score and 0 being the worst.
次要结局
- Burden of Disease and Quality of Life Changes using the Veterans RAND 12 Item Health Survey (VR-12)(6 months)
- Functional Benefit and Pain level Changes using the modified Harris Hip Score (HHS)(6 months)
- Functional Benefit and Pain level Changes using the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(6 months)
- Pain Changes using the Visual Analogue Scale (VAS)(6 months)
研究者
Ivan Wong
Orthopaedic Surgeon MD FRCS(C), Dip. Sports Medicine
Nova Scotia Health Authority