Safety and Performance of FibroFix™ Cartilage P Implant and Drill Set for Articular Cartilage Repair Within the Knee Joint
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Safety endpoint - year 1
研究概览
简要总结
This is a multi-center first-in-human prospective clinical investigation to evaluate the safety and performance of the FibroFix™ Cartilage P Implant and Drill Set. The Implant is a medical device designed by Orthox Ltd. to repair a damaged area of cartilage within the knee joint.
The aim is to 75 participants over two Stages:
In STAGE I, up to a total of 6 subjects will be recruited and safety assessed after 6 months of follow-up.
In Stage II an additional 69 subjects. The subjects will be followed up for 2 years with MRI imaging, then a further 8 years with patient outcome questionnaires.
详细描述
This is a multi-center, prospective, non-randomized, open-label clinical investigation. Safety oversight throughout will be provided by an independent data monitoring committee (DMC). The clinical investigation will be split into two stages.
Stage I of the clinical investigation will enroll a small cohort of subjects, up to a total of 6 (accounting for a 17% dropout rate) having been implanted with the FibroFix Cartilage P, to provide a minimum of 5 evaluable subjects. The initial safety of the FibroFix Cartilage P implant and the FibroFix Cartilage P Drill Set will be evaluated in these subjects across a maximum of 2 sites. Recruitment into the clinical investigation will then be paused.
Following the implantation of FibroFix Cartilage P in the initial cohort of subjects, the DMC will monitor all emerging safety issues against the stopping rules of the clinical investigation. Any treatment-emergent Serious Adverse Events (SAE) or other safety concerns during Stage I of the clinical investigation will immediately be referred, on a case-by-case basis, to the DMC for review against the stopping rules.
A formal review of safety against the stopping rules will be undertaken by the DMC at two-time points:
- when all of the initial cohort of subjects complete 3 months post-surgery follow-up;
- when all of the initial cohort of subjects complete 6 months post-surgery follow-up.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to provide written informed consent;
- •Age ≥18 years at time of enrolment;
- •Able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and imaging evaluations and the recommended rehabilitation regimen as determined by the Investigator;
- •Has a joint surface lesion, ICRS Grade 3 or above, on femoral condyles;
- •Female subjects of child-bearing potential: a negative urine pregnancy test at time of enrolment.
- •Patient has been diagnosed by MRI or other imaging technique to confirm presence of cartilage lesion and the lesion remains symptomatic. Only patients for whom the decision to perform surgery has already been made will be invited to participate. Asymptomatic lesions will NOT be included;
- •Intra-Operative Inclusion criterion:
- •Lesion area of less than of 26.6 mm height and less than 20.0 mm width in the index knee after debridement.
排除标准
- •Age >65 years or <18 years at time of enrolment;
- •Body Mass Index (BMI) > 35;
- •Lesion area of more than 26.6 mm length and more than 20.0 mm width in the index knee after debridement;
- •Patient has multiple lesions to be treated;
- •Articular cartilage lesions in the tibia or patella, ICRS grades 3 and above;
- •KOOS Pain Subscale score at baseline that is < 20 or >
- •(Scale range: Maximum pain = 0, pain free = 100);
- •Patient has previously received the FibroFix™ Cartilage P implant;
- •Patient suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee;
- •Clinically significant untreated ligament instability of the same knee,
- •Patient is post op from surgery on the same knee within 6 months which stipulates on-going rehabilitation,
- •Untreated, symptomatic, unstable meniscal lesions on patients with residual meniscus volume of <50% in the same compartment,
- •Joint malalignment that in the opinion of the treating surgeon, requires osteotomy to correct,
- •Any previous surgical cartilage treatment in the index knee within the previous 6 months,
- •Evidence of osteonecrosis of the involved knee.
- •A known allergy to:
- •General and/or regional anaesthetic,
- •Silk or silk containing products, or
- •Glycerol or products containing glycerol.
- •Demonstrating an active local or systemic infection;
- •Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Cartilage P implant and clinical outcome;
- •A history of confirmed anaphylactoid reaction;
- •Has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery;
- •Medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis;
- •If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6 months at time of enrolment;
- •Currently participating in another device or drug clinical investigation or has done so in the previous 3 months which would impact the results of the surgery in the opinion of the surgeon or be a barrier to participation.
结局指标
主要结局
Safety endpoint - year 1
时间窗: up to year 1 after surgery
Incidence of device related Adverse Events
Change in Knee injury and Osteoarthritis Outcome score (KOOS) - year 1(Pain and Sport/Rec only)
时间窗: baseline (pre-surgery) to 1 year after surgery
The knee injury and Osteoarthritis Outcome Score is a patient-assessed outcome score. Questions use a 5-point Likert scale response. KOOS is scored into 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL) Sport and Recreation Function (Sport/Rec), and knee-related quality of life (QoL). Each subscale ranges from 0 indicating extreme symptoms to 100 indicating no symptoms. Subscale scores will be aggregated and averaged as a primary outcome. Change from baseline of 8 points in KOOS Pain scores and Function (Sport/Rec) scores at 1-year post-surgery.
次要结局
- Safety endpoint -year 10(up to year 10 after surgery)
- Change in KOOS -year 2(baseline (pre-surgery) to year 2 after surgery)
- Change in KOOS - year 10(baseline (pre-surgery) to year 10 after surgery)
- Change in KOOS -month 6(baseline (pre-surgery) to month 6 after surgery)
- Change in KOOS -year 4(baseline (pre-surgery) to year 4 after surgery)
- Change in KOOS -year 3(baseline (pre-surgery) to year 3 after surgery)
- Change in KOOS -year 5(baseline (pre-surgery) to year 5 after surgery)
- Change in KOOS -month 3(baseline (pre-surgery) to month 3 after surgery)
- Change in KOOS -year 6(baseline (pre-surgery) to year 6 after surgery)
- Change in Tegner Activity Scale -month 3(baseline (pre-surgery) to month 3 after surgery)
- Change in Tegner Activity Scale -month 6(baseline (pre-surgery) to month 6 after surgery)
- Change in EQ-5D-5L -month 6(baseline (pre-surgery) to month 6 after surgery)
- Magnetic Resonance Imaging -year 1(baseline (pre-surgery) to year 1 after surgery)
- Safety endpoint - month 3(up to month 3 after surgery)
- Safety endpoint -year 6(up to year 6 after surgery)
- Safety endpoint -year 9(up to year 9 after surgery)
- Change in KOOS -week 6(baseline (pre-surgery) to week 6 after surgery)
- Change in KOOS -year 1(baseline (pre-surgery) to year 1 after surgery)
- Change in KOOS -year 9(baseline (pre-surgery) to year 9 after surgery)
- Change in Lysholm knee score -week 2(baseline (pre-surgery) to week 2 after surgery)
- Change in Tegner Activity Scale -year 1(baseline (pre-surgery) to year 1 after surgery)
- Safety endpoint -year 8(up to year 8 after surgery)
- Change in Lysholm knee score -year 1(baseline (pre-surgery) to year 1 after surgery)
- Change in Lysholm knee score -year 2(baseline (pre-surgery) to year 2 after surgery)
- Change in Tegner Activity Scale -week 6(baseline (pre-surgery) to week 6 after surgery)
- Change in Tegner Activity Scale -year 2(baseline (pre-surgery) to year 2 after surgery)
- Change in Visual Analogue Score (VAS) - week 2(baseline (pre-surgery) to week 2 after surgery)
- Change in Visual Analogue Score (VAS) - month 3(baseline (pre-surgery) to month 3 after surgery)
- Usability Questionnaire - Processing staff(after processing of instruments)
- Safety endpoint -year 3(up to year 3 after surgery)
- Change in KOOS -year 7(baseline (pre-surgery) to year 7 after surgery)
- Change in KOOS -year 8(baseline (pre-surgery) to year 8 after surgery)
- Change in Lysholm knee score -month 3(baseline (pre-surgery) to month 3 after surgery)
- Change in Tegner Activity Scale -week 2(baseline (pre-surgery) to week 2 after surgery)
- Change in Visual Analogue Score (VAS) - year 1(baseline (pre-surgery) to year 1 after surgery)
- Change in EQ-5D-5L -year 1(baseline (pre-surgery) to year 2 after surgery)
- Magnetic Resonance Imaging -month 3(baseline (pre-surgery) to month 3 after surgery)
- Change in Lysholm knee score -week 6(baseline (pre-surgery) to week 6 after surgery)
- Change in Lysholm knee score -month 6(baseline (pre-surgery) to month 6 after surgery)
- Change in Visual Analogue Score (VAS) - week 6(baseline (pre-surgery) to week 6 after surgery)
- Change in Visual Analogue Score (VAS) - month 6(baseline (pre-surgery) to month 6 after surgery)
- Change in Visual Analogue Score (VAS) - year 2(baseline (pre-surgery) to year 2 after surgery)
- Magnetic Resonance Imaging -month 6(baseline (pre-surgery) to month 6 after surgery)
- Magnetic Resonance Imaging -year 2(baseline (pre-surgery) to year 2 after surgery)
- Safety endpoint -year 2(up to year 2 after surgery)
- Safety endpoint -year 5(up to year 5 after surgery)
- Safety endpoint -year 7(up to year 7 after surgery)
- Usability Questionnaire - Surgeons and Theatre nurses(immediately post-surgery)
- Usability Questionnaire - Patients(pre-discharge from hospital)
- Safety endpoint - month 6(up to month 6 after surgery)
- Safety endpoint -year 4(up to year 4 after surgery)