Early Regenerative Intervention for Post-Traumatic Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Radiographic Changes
研究概览
简要总结
The goal of the proposed research is to compare the ERIPTO protocol for post-traumatic osteoarthritis of the knee with that of bone marrow aspirate concentrate (BMAC) only. The investigators will also conduct a statistical regression analysis looking into factors such as time frame from initial injury, the type of injury, gender, and age when injury first occurred. The investigators plan on evaluating clinically and radiographically the effects of the ERIPTO Protocol. There will be two arms of this study. The first arm will be our protocol arm and the second arm will be our BMAC treatment only arm. The investigators plan on collecting objective data on osteoarthritis (OA) severity by taking plain films and assessing the Kellgren-Lawrence (KL) grading scheme in assessing OA severity. The investigators will also administer MRI evaluations for cartilage and meniscal growth prior to treatment and after 1 year. The investigators also plan on collecting subjective symptom scores in the form of knee injury and osteoarthritis outcomes scores (KOOS), visual analog scores (VAS), and international knee documentation criteria (IKDC) score for OA severity. The investigators plan to track changes in both subjective and objective measures of knee OA in our patients through the course of one year.
详细描述
The field of regenerative medicine and orthobiologics have raised the interests of many clinicians and members of the scientific community. Over the last 20 years there has been a great interest and growth in this field, a Scopus search for musculoskeletal and stem cells resulted in over 3000 documents, with more than a third being reviews. A PubMed search in the past 6 years resulted in 52 publications in the last 5 years.
Unfortunately, the fragmentation of regenerative medicine has occured with many clinicians using generalized protocols resulting in little significant clinical improvement or short-term benefits that often fade over time.
There is still a great deal of research which needs to be done to elucidate how best to utilize the various components of regenerative medicine as well as the pathophysiology of osteoarthritis.
The ERIPTO study seeks to study a proposed protocol utilizing various components of regenerative medicine including platelet rich plasma (PRP), hyaluronic acid (HA), and human bone marrow aspirate concentrate (BMAC).
In trauma and normal wound healing collagen is often the initial activator of platelets with development of platelet monolayers over the exposed collagen surfaces as seen in post-traumatic joints. This is opposed to immediate proteolytic cleavage of platelets by thrombin with subsequent immediate release of stored growth factors. Investigations of gene expression within joints following mechanical injury to articular cartilage have been studied. In a shear versus impaction model investigators found an increase in the expression of collagen type 1 following trauma to the articular surface. This expression of collagen may act as an anchor for percutaneously injected PRP in post-traumatic joints to help facilitate steady secretion of growth factors.
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)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 25-60 men and women
- •evidence of OA both clinically and on plain films, at least KL grade 1
- •no previous intra-articular treatment in the past 3 months
- •In good health and active individuals exercising 1-2 times per week
- •BMI 25-30
- •History of meniscal, ligamentous, capsular, or articular cartilage lesions in the past
- •History of impaction injury, femoral condyle fracture, tibial plateau fracture, or any OCD lesions within ≤ 5 years
排除标准
- •Patients receiving regenerative therapies within the last 12 months
- •Patients receiving corticosteroid injections within the last 3 months
- •Patients with artificial joints
- •Patients with secondary OA from non-traumatic mechanisms (i.e. RA or any inflammatory arthropathies)
- •Patients with multiple co-morbidities that may affect the inflammatory state
- •History of sleep disorders
- •History of residual irregularity of articular surfaces, excessive joint instability
- •History of impaction injury, femoral condyle fracture, tibial plateau fracture, or OCD lesions > 5 years
- •History of malignancy, blood dyscrasias, or platelet dysfunction
- •Active systemic or local infections, particularly with Klebsiella Pneumoniae, Enterococcus, and Pseudomonas
结局指标
主要结局
Radiographic Changes
时间窗: 1 year
Magnetic resonance imaging evaluations pre-treatment and post-treatment measuring evidence of changes in post-traumatic osteoarthritis of the knee including articular cartilage quality, presence of subchondral bone marrow edema, presence of osteophytes, medial and lateral meniscal quality, ligamentous integrity, and presence of effusion.
次要结局
- Subjective Knee Symptom Changes(1 year)