Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
Osteoarthritis (OA) is a leading cause of disability around the world. The aging population is only further increasing its prevalence. Moreover, increasing rates of obesity, as well as increasing athletic participation, is leading to patients developing OA at younger ages. Although total joint replacement is effective for alleviating the effects of OA for many patients, it is less beneficial for younger patients given the resultant reduced mobility and the ~15 year life of a total joint replacement. Therefore, new options are needed for OA.
One such option is bone marrow aspirate concentrate (BMAC) injection into the diseased joint. Several recent studies have shown significant symptomatic improvement from this therapy. Now, efforts are needed to better understand how to optimize this therapy, as numerous variables are involved, including: the volume of aspirate, adjuvant, aspiration location or locations, anesthetic, etc. Additionally, several FDA-approved needles are available for the aspiration step. Thus, the purpose of this study is to compare two different styles of FDA-approved needles--an open-ended trocar vs. a fenestrated blunt trocar--with respect to clinical outcomes, cell counts, and colony forming units.
In addition to the comparison arms, taking these two groups together, this study will serve as prospective case series of 30 patients undergoing BMAC injection for knee osteoarthritis without a platelet-rich plasma (PRP) or any other adjuvant/carrier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-79
- •Patients have tried at least 6 weeks of conservative therapy including: activity modification, weight loss, brace, NSAIDs, corticosteroid injection
- •Radiographically confirmed Kellgren-Lawrence I-III OA (no bone-on-bone)
- •Patients can provide written informed consent
排除标准
- •Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiencies
- •History of meniscal injury other than degenerative meniscal tears
- •Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
- •Major mechanical axis deviation of more than 50% into either compartment (varus or valgus)
- •Intra-articular injection to affected knee within 3 months of intra-articular BMA injection or HA within 6 months
- •Body mass index of 35 or more; 18.5 or less (malnourished)
- •Active infection
- •Ongoing infectious diseases, including HIV and hepatitis
- •Clinically significant diabetes, cardiovascular, hepatic, or renal disease
- •Active malignancy, undergoing treatment, has undergone treatment, or has decline treatment
- •Use of anti-inflammatory medications, including herbal therapies, within 7 days of BMA
- •Use of anti-rheumatic medications, including methotrexate and other antimetabolites, within 3 months prior to study entry
- •History of radiation therapy
- •History of or current drug or alcohol use disorder
- •Current cigarette smokers
- •History of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)
- •History of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)
- •Pregnant or currently breast-feeding
- •Participation in a study of an experimental drug within 60 days of study entry
结局指标
主要结局
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 1 week, 6 weeks, 6 months
Will assess for change in patient reported outcome measure that assesses symptoms, stiffness, pain, function, and quality of life from pre-procedure to post-procedure.
次要结局
- Change in Visual Analog Pain Scale (VAS) of affected knee(Baseline, 1 week, 6 weeks, 6 months)
- Change in Tegner Score(Baseline, 1 week, 6 weeks, 6 months)
- Visual Analog Pain Scale (VAS) of aspiration site(Baseline (immediately after intervention), 1 week, 6 weeks, 6 months)
- Change in Lysholm Score(Baseline, 1 week, 6 weeks, 6 months)