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临床试验/CTRI/2015/06/005841
CTRI/2015/06/005841Other1/2 期

Role of Autologous Chondrocyte Implantation in Chondral Defects of Knee Joint

Sri Sathya Sai Institute of Higher Learning1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月6日最近更新:

试验速览

阶段
1/2 期
状态
Other
入组人数
50
试验地点
1
主要终点
. reaching the pre-injury level of activities.

研究概览

简要总结

This study has been terminated due to lack of funding.

Articular (hyaline) cartilage, which is composed mainly of water and a collagenous extracellular matrix, provides a smooth and resilient surface at the ends of bones, allowing virtually frictionless movement within the knee joint. It also acts as a shock absorber, cushioning the bone from forces of more than five times the body’s weight. The cellular component of hyaline cartilage is the chondrocyte, which is responsible for the production and maintenance of the matrix. Cartilage lacks blood and nerve supplies, and it has a limited potential for self-repair. Hence, Autologous Chondrocyte Implantation (ACI) helps in regeneration of the chondral defects.

Cartilage damage in the knee can be caused directly by injury, often as a result of sporting activity, or spontaneously (a condition called osteochondritis dissecans). Loss of cartilage alone is referred to as chondral damage, whereas loss of bone and cartilage is known as osteochondral damage. Symptoms associated with the loss of hyaline cartilage include knee pain, knee swelling, Locking of knee and giving way of the knee joint. Ultimately, mechanical damage to the joint surface can lead progression of the chondral defect and eventually to osteoarthritis, which will warrant a total knee replacement in future. Following ACI procedure, the patient may lead a normal active lifestyle and participate in sporting activities.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with Femoral chondral defects in the age group of 18 to 50.

排除标准

  • a)Patients below the age of 18 years and above the age of 50 years.
  • b)Co-morbidities such as inflammatory arthritis and metabolic and endocrinal diseases.
  • c)Patients unfit for surgical procedures from anaesthesia point of view.
  • d)Patients with joint deformities in lower extremity.

结局指标

主要结局

. reaching the pre-injury level of activities.

时间窗: 3 months

.Improvement in pain scores

时间窗: 3 months

.Improvement in range of motion of knee.

时间窗: 3 months

. prevention of the progression of the chondral defect to Osteoarthritis of knee.

时间窗: 3 months

次要结局

  • . The patient may be able to participate in active sports and other activities(. the procedure would help in the healing of the cartilage which is almost similar to hyaline cartilage present in non-injured knee.)

研究者

申办方类型
Research institution

研究点 (1)

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