Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 7
- 主要终点
- Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.
详细描述
- Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).
- All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.
- Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)
- All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).
- Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
- Measures to assess effectiveness and safety will be conducted at all follow-ups.
- Safety will be assessed by the collection of adverse events at all timepoints.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 50
- •One or two cartilage defects Grade III or IV according to Outerbridge classification
- •Defect size between 2 and 10 cm2 (inclusive)
- •Intact normal surrounding cartilage to suture the Chondro-Gide® membrane
- •Informed consent
- •Patient willing to fulfill a strict postoperative physiotherapy scheme
排除标准
- •More than 2 defects
- •Defects on both knees
- •X-ray signs of osteoarthritis
- •Bone lesion > 0.7 cm in the defect
- •Knee instability, varus or valgus deformation, status after complete meniscus resection, status after mosaicplasty, patella dysplasia
- •Rheumatoid, infectious disease
- •Skin lesion on the operated knee
- •Treatment with cartilage building medication
- •Drug and alcohol abuse
- •Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B
- •Pregnancy or lactation
- •Collagen allergy
- •Participation in other Trials
研究组 & 干预措施
microfracture
Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair
干预措施: Microfracture (Procedure)
Microfracture with Chondro-Gide sutured
Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure
干预措施: Chondro-Gide sutured (Device)
Microfracture with Chondro-Gide glued
Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure
干预措施: Chondro-Gide glued (Device)
结局指标
主要结局
Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
时间窗: 2 years post-surgery
The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score
MRI (magnetic resonance imaging) assessment of structural repair parameters.
时间窗: 6 months and 1,2 and 5 years post-surgery
Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).
次要结局
- Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.(6 months and 1,2 and 5 years post-surgery)
- Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).(6 months and 1,2 and 5 years post-surgery)
- Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".(6 months and 1,2 and 5 years post-surgery)
- Adverse Events (AE) Review(5 years post-surgery)