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临床试验/NCT02308358
NCT02308358撤回不适用

Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee.

University of Missouri-Columbia1 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Activity Level

研究概览

简要总结

The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

详细描述

Localized articular cartilage defects are a common and challenging problem, particularly in young patients. These defects cause significant disability and, as participation in sports activity grows, are increasing in overall number annually. A recent systematic review evaluating the overall full-thickness focal chondral defects in athletes revealed the prevalence to be 36%, with 22% of the athletes being symptomatic. As the prevalence of these injuries increases, they pose increasingly significant challenges to the clinicians who treat them.

Normal joint cartilage is a firm, elastic tissue that covers the ends of bones to protect them and allow smooth, pain-free movement over each other. Joint cartilage is described, macroscopically and microscopically, as articular or "hyaline" cartilage. Hyaline cartilage is often described as a "glass-like" structural tissue because of its shiny appearance and translucency. The tissue structure is a hydrated matrix consisting of proteoglycans and at least 90% (dry weight) Type II collagen fibers. The collagen fibers contribute to the overall tensile strength and the proteoglycans provide the stiffness and tissue resiliency. Cartilage cells, or chondrocytes, produce dense matrix, which effectively incarcerate the cells themselves. In the event of injury, the motility of these cells is restricted due to their inclusion deep inside the matrix, and the avascularity of the cartilage itself. This lack of a vascular network prevents the infiltration of inflammatory cells and bioactive molecules following damage. Thus, once damaged, adult articular cartilage will not effectively heal or regenerate.

Treatment techniques of osteochondral lesions are relatively new and frequently changing and evolving. The treatment algorithms for these injuries are complex and often involve multiple procedures, including non-surgical interventions with pharmacological agents such as oral non-steroidal anti-inflammatory drugs (NSAIDs), injectable corticosteroids, and activity modification including rehabilitation and support braces that may provide incomplete or temporary relief. Lesion characteristics such as grade and thickness may also impact treatment options and recovery. Arthroscopic debridement and lavage is effective as a first-line surgical approach for subjects with low physical demands. This procedure eliminates debris and decreases inflammation in the joints, but the symptomatic relief is usually transient and the lesion is not repaired. Treatments providing long-term results may be achieved through a variety of surgical options.

There are many surgical treatments options currently available and each have limitations. Marrow stimulation techniques include microfracture, drilling, and abrasion arthroplasty. The Microfracture technique has been described to address lesions up to 1 cm2 while other authors cite more specific applications depending on lesion size, patient age and physical demands. While microfracture is considered a reparative treatment, the procedure can produce less than optimal results because of the inferior nature of fibrocartilaginous tissue formed. Unlike the Type II collagen normally found in articular cartilage, fibrocartilage consists predominately of Type I collagen. Because it lacks the long-term wear characteristics of normal hyaline cartilage, fibrocartilage can degrade with time.

ACI is a two-staged procedure developed to treat cartilage defects in the knee. For ACI, a primary arthroscopic procedure is performed to assess the defect and a small amount (200mg to 400 mg) of healthy, autologous cartilage is harvested. The tissue is then expanded using a cell-culture process over a period of several weeks. The expanded cells are then implanted into the area of the defect during a second surgical procedure. Studies have demonstrated through histology and quantitative measurements that ACI produces a "hyaline-like cartilage" with a collagen type II content of between 35 percent and 55 percent. Literature indicates that hyaline cartilage may have greater biomechanical strength and integrity than the fibrocartilaginous tissue generated in lesions treated with microfracture. There are several disadvantages using ACI, however, such as the need for two surgeries. It has increased surgical time due to and it is associated with substantial cost to account for ex vivo cell expansion. Potential postoperative complications related to the periosteal patch include cell leakage, hypertrophy and/or delamination, and unequal chondrocyte distribution within the lesion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age ≥18 years
  • Femoral condyle osteochondral defect ≥10mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation, defect <10mm for microfracture treatment
  • Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
  • Must be able and willing to follow a standardized rehabilitation protocol.
  • Must be able to read and understand English or a language for which translated versions of the patient reported questionnaires and Informed consent form are available.
  • Must be able to sign informed consent and must voluntarily sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved subject Informed Consent Form.

排除标准

  • Presence of ipsilateral articular fractures, knee ligament injuries or extensor mechanism injuries
  • Presence of severe soft tissue injuries around the knee that have required or may require skin grafting or flap coverage.
  • Presence of a previous below knee amputation
  • Presence of inflammatory systemic arthritis or disease involving the index joint (i.e. gout)
  • Is a prisoner
  • Is receiving workman's compensation
  • Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements
  • Based on a clinical history, physical examination and/or subject presentation, subject has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements

结局指标

主要结局

Activity Level

时间窗: 1 Year

Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

Pain Level

时间窗: 1 Year

Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Stannard

Professor and Chairman - Orthopaedic Surgery

University of Missouri-Columbia

研究点 (1)

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