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临床试验/NCT01947374
NCT01947374已完成3 期

Matrix-encapsulated Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures for Articular Cartilage Regeneration. Randomised Clinical Trial.

Instituto Nacional de Rehabilitacion1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
48
试验地点
1
主要终点
MRI T2 Mapping

研究概览

简要总结

This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm
  • •Signed patient informed consent.
  • •Agree to adhere to rehabilitation protocol.

排除标准

  • •Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
  • •Total meniscectomy
  • •Malalignment
  • •Evidence of osteoarthritis

研究组 & 干预措施

Chondrocyte implantation

Experimental

From a previous biopsy, articular cartilage matrix is digested and chondrocytes are cultured in 2 passages until implants with at least 6,000,000 cells are constructed. These constructus of 8 mm in diameter are implanted arthroscopically by means of biodegradable anchor (MINILOK QUICKANCHOR TM from DePuy-Mitek ) located at the defect and tied securely.

干预措施: Matrix encapsulated chondrocyte implantation (Procedure)

Microfractures

Experimental

Subchondral bone perforations that allow a clot to be formed, and subsequent scar at the cartilage defect area.

干预措施: Microfracture awl (Procedure)

结局指标

主要结局

MRI T2 Mapping

时间窗: 24 months

Special magnetic resonance imaging technique for measurement of collagen and water content, expressed in milliseconds.

次要结局

  • Clinical evaluation(0, 10, 30 days; 3, 6, 9 ,12, 24, 36 months)

研究者

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

Aldo Izaguirre

Dr./Study Director

Instituto Nacional de Rehabilitacion

研究点 (1)

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