NCT06344481招募中不适用
A Prospective, Multicenter, Single-Arm, 2-Phase First-in-Human Feasibility Study of the HYALEX® Cartilage System
Hyalex Orthopaedics, Inc.4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Freedom from implant rejection and infection.
研究概览
简要总结
The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-65 years.
- •Body Mass Index (BMI) ≤
- •Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.
- •Symptomatic, single treatable area 1 - 3.8cm
- •Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and
- •Stable knee.
- •Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
- •Inclusion Criteria - Phase 2
- •21-65 years.
- •Body Mass Index (BMI) ≤
- •Up to three treatable joint surface lesion(s), ICRS Grade 3 or 4, located on the medial or lateral femoral condyle(s).
- •Symptomatic total treatable area 1 - 10cm
- •Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and
- •Stable knee.
- •Non-responsive to a minimum of 3 weeks of conservative treatment, consisting of non-steroidal anti-inflammatory drugs and/or physical therapy.
排除标准
- •Phase 1 & 2
- •HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:
- •Known allergy to polyurethanes, bone cement, acrylic, or titanium.
- •Lack of 2mm of healthy cartilage (ICRS Grade 0 or 1) and 2mm of vital bone wall on all sides of the implant site.
- •Osteochondral defect affecting subchondral bone more than 11mm in depth from adjacent non-defect articular surface.
- •Bipolar cartilage lesions involving patellar or tibial lesions ICRS Grade 3 - 4 opposite the lesion intended for treatment.
- •Insufficient bone stock or bone density determined intra-operatively preventing implant press fit.
- •Patient Orthopaedic Health Exclusions:
- •Kellgren and Lawrence (KL) grade 3 or 4 on standing radiographs as defined:
- •Hip-knee-ankle (HKA) angle of greater than +/- 5 degrees (varus or valgus malalignment > 5 degrees) on standing X-ray.
- •Lack of normally functioning contralateral knee that restricts activity.
- •Insufficiency fracture of the femoral condyle or tibial plateau.
- •Recent Osteochondritis Dissecans within 1 year.
- •Diagnosis of a concomitant knee injury which the investigator believes may interfere with study participation or confound effectiveness assessment.
- •Any known systemic cartilage and/or bone disorder, such as but not limited to osteoporosis, chondrodysplasia or osteogenesis imperfecta.
- •A symptomatic musculoskeletal condition in the lower limbs that could impede effectiveness measurements in the target knee.
- •Any known tumor of the treatment knee.
- •Prior radiation therapy to the knee joint.
- •Clinically significant or symptomatic vascular or neurological disorder of the lower extremities affecting gait or function.
- •Untreated ACL and/or PCL deficiency or complex ligamentous instability of the study knee according to IKDC Grade C (abnormal) or D (severely abnormal).
- •Previous Surgery and Intervention Exclusions:
- •Previous surgery in the past 6 months on the index knee except for:
- •Diagnostic knee arthroscopy and/or debridement / chondroplasty, and
- •Meniscectomy
- •Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.
结局指标
主要结局
Freedom from implant rejection and infection.
时间窗: Through 24 months.
Assess the safety (implant rejection, infection) and tolerability of the Hyalex Cartilage Implant.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months.
时间窗: Through 12 months.
The KOOS assesses patient pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
次要结局
未报告次要终点
研究者
研究点 (4)
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