The HYALEX Freestyle™ Resurfacing System Pivotal Study: A Multicenter, Single-Arm, Pivotal Study of the HYALEX Freestyle Resurfacing Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Freedom from implant rejection and infection.
研究概览
简要总结
A multicenter, open-label, single-arm, pivotal study to evaluate the safety and effectiveness of the HYALEX Freestyle Resurfacing System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Freestyle Resurfacing Implant.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22-70 years.
- •Body Mass Index (BMI) ≤
- •Up to two treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial and/or lateral femoral condyle.
- •Up to 2 implants (one implant per condyle) to treat up to 2 individual symptomatic lesions with a total summative area up to 4.52cm2 / condyle.
- •Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score between 20 and
- •Ligamentously stable knee.
- •Failure of non-operative treatment (e.g., physical therapy, physician-directed at home exercise program, intra-articular injections, bracing) for at least 4 months prior to consideration for participation in the study.
排除标准
- •HYALEX Implant, Surgical Technique, and Lesion Site Exclusions:
- •Known allergy to polyurethanes, bone cement, acrylic, or titanium.
- •Lack of 2mm of cartilage (ICRS Grade 0 to 2) 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.
- •Hip-knee-ankle (HKA) angle of greater than +/- 8 degrees (varus or valgus malalignment > 8 degrees) on standing X-ray.
- •Lack of normally functioning contralateral knee that restricts activity.
- •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.
- •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 surgical cartilage treatment in the index knee within the last 6 months
- •Previous intra-articular injections, including HA and steroids, within the last 3 months prior to the date of surgery.
- •Patient Overall Health and Health History Exclusions:
- •Any known history of inflammatory arthropathy or untreated or uncontrolled crystal-deposition arthropathy.
- •Current cigarette smoker or user of other nicotine products.
- •Known Type 1 or Type 2 insulin-dependent diabetes mellitus.
- •Currently undergoing immunosuppressive therapy or long-term steroid use (corticosteroid, excluding inhalers) or within 3 months prior to surgery.
研究组 & 干预措施
HYALEX Freestyle Resurfacing System
Implantation of the HYALEX Implant
干预措施: Hyalex Knee Cartilage System (Device)
结局指标
主要结局
Freedom from implant rejection and infection.
时间窗: 12 months
To assess the safety (implant rejection, implant dislocation or disassociation (delamination), infection) and tolerability of the Hyalex Knee Cartilage Implant.
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months.
时间窗: 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.
Composite Primary Endpoint
时间窗: 12 months
* A clinically significant improvement in KOOS Pain score; * A clinically significant improvement in KOOS ADL score; * Lack of treatment-related SAEs; and * Absence of secondary surgical intervention defined as HYALEX Freestyle Resurfacing Implant removal or revision due to a treatment-related finding.
次要结局
未报告次要终点