Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Western Ontario McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows:
Specific Aim 1: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months).
Hypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection.
Specific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months).
Hypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time.
Specific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score.
Hypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected.
The investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient.
Patients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.
详细描述
The goal of the study is to enroll 50 subjects in the bone marrow arm (BMAC group) and 50 in the triamcinolone arm (triamcinolone group). Once part fulfill the inclusion criteria, participants will be randomized to either intervention.
Participants will be enrolled in a staggering manner for the BMAC arm. The first 4 participants will be enrolled with at least 1 week interval in between these patients. During these weeks, the investigators will obtain results from the BMAC culture and evaluate safety response to the procedure. Participants enrolled in the triamcinolone arm will not be enrolled in a staggering manner, as the safety and efficacy are established as this is part of standard of care for hip osteoarthritis.
Participants will have the study protocol explained to them and will consent to the study, agreeing to have the bone marrow aspiration (BMA) and hip injection performed. Prior to any interventions, the participants will complete the baseline patient reported outcomes scores, and blood draw.
Inclusion and exclusion criteria will be assessed during screening. Kellgren-Lawrence grade will be determined by blinded radiologists and co-investigators (Drs. Amer Hanano and Matthew Robbins). An average score will be taken.
In order to blind the patient of the intervention, the triamcinolone group will undergo a "sham" bone needling of the bone cortex to simulate bone marrow harvesting (BMH). The posterior iliac spine will be anesthetized and needled simulating a BMH. Following the needling, the group will then receive a triamcinolone injection.
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 (Participant)
盲法说明
Participant will undergo a sham bone needling if assigned to Triamcinolone group to keep patient blinded to their intervention. This will simulate the bone marrow aspiration process.
Outcomes assessor will receive de-identified data including the treatment type.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged between 18 - 75 years old
- •WOMAC Pain Subscale Total Score of 5 or higher in the Likert Scale (total score is 20)
- •Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays
- •Body Mass Index ≤ 35 kg/m^2
- •Unilateral or Bilateral Hip Osteoarthritis
- •Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program
- •Agreement to adhere to Lifestyle Considerations
- •Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
- •Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy/radiation therapy such as breast cancer, colon cancer, or skin cancer, and others could participate when deemed in remission for 1 year. Written approval from oncologist will be necessary prior to enrollment
- •Negative gram stain result
排除标准
- •Prior corticosteroid injection to the hip
- •History of hip replacement(s)
- •Noncompliance to preventive screening tests for cancer indicated by age
- •Active autoimmune disease
- •Current use of oral corticosteroid
- •Use of immunosuppressive medications, or who are known to me immunocompromised
- •Inability to be weaned of oral anti-inflammatory medications
- •History of Diabetes or HbA1c ≥ 6.5%
- •Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL
- •Vitamin D Level < 30 ng/ml
- •Anemia (Hgb < 11.7 g/dL for Women; Hgb < 13 g/dL for men)
- •eGFR < 60 mL/min/1.73 m^2
- •Thrombocytopenia with platelet count less than 150,000 x 10^9 L
- •Patients with coagulopathies based on known clotting disorder
- •Patients currently on anti-coagulation therapies
- •Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C
- •Moving over the next year
- •Inability to consent to the research study
- •Inability to complete forms electronically
- •Subjects in any other clinical trials
- •History of allergic reaction to lidocaine
- •Pregnancy or planning to be pregnant during trial
- •Breastfeeding
研究组 & 干预措施
Bone marrow aspirate concentrate
Bone marrow that is aspirated then concentrated using a device.
干预措施: Aspire Needle + Emcyte PureBMC (Combination Product)
Triamcinolone
Triamcinolone is a corticosteroid.
干预措施: Triamcinolone (Drug)
结局指标
主要结局
Western Ontario McMaster Universities Arthritis Index (WOMAC)
时间窗: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 weeks.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario McMaster Universities Arthritis Index (WOMAC)
时间窗: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 3 months.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario McMaster Universities Arthritis Index (WOMAC)
时间窗: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 months.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario McMaster Universities Arthritis Index (WOMAC)
时间窗: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
次要结局
- 6 Minute Walk Test (6MWT)(Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 weeks.)
- 6 Minute Walk Test (6MWT)(Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 3 months.)
- 6 Minute Walk Test (6MWT)(Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 months.)
- 6 Minute Walk Test (6MWT)(Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.)
研究者
LEONARDO OLIVEIRA
Principal Investigator
The Cleveland Clinic