A Prospective, Multi-center Clinical Study to Evaluate the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal Allograft Transplantations (MAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Reoperations at 12 Months
研究概览
简要总结
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.
详细描述
This PMCF study is to satisfy the post-market surveillance obligations to the European Medical Device Regulation (EU MDR 2017/745). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.
The objectives of the study are to assess the clinical success rate of both clinical indications (meniscal repair and meniscal allograft transplantations) and the performance and safety of the FAST-FIX FLEX meniscal repair system.
The sample size for this study is precision-based, and not based on statistical power considerations, thus no formal statistical hypothesis is formulated.
The primary endpoint for the study upon which sample size is determined is meniscal repair success rate in the study device at 12 months.
Additionally, secondary endpoints in this study assess success rate, meniscus healing and clinical performance of Patient Reported Outcomes (PRO) for meniscal repair and meniscal allograft transplantations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meniscal Repair Inclusion Criteria:
- •Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form;
- •Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening;
- •Subject is willing and able to participate in required follow-up visits and is able to complete study activities;
- •Subject requires a meniscal repair;
- •Subject is suitable to participate in the study in the opinion of the Investigator;
- •Subject requires a meniscus repair concerning the red-red or red-white zones for acute or chronic 1-, 2- or 3-segment lesions, with or without associated anterior cruciate ligament (ACL) reconstruction.
- •Meniscal Allograft Transplantation Inclusion Criteria:
- •Subject provides written informed consent for study participation using an independent ethical committee (IEC) / institutional review board (IRB) approved consent form;
- •Subject is between sixteen (16) and seventy (70) years of age, inclusive at the time of screening;
- •Subject is willing and able to participate in required follow-up visits and is able to complete study activities;
- •Subject requires a meniscal allograft transplantation;
- •Subject is suitable to participate in the study in the opinion of the Investigator.
- •Subject requires a MAT for symptomatic meniscal insufficiency (load-related pain and swelling in the compartment post meniscectomy) for which conservative treatment has failed, with or without cartilage repair or restoration (including ACL reconstruction or repair).
- •Meniscal Repair
排除标准
- •Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX FLEX implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation;
- •Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study;
- •Women who are pregnant or nursing;
- •Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their legally authorized representative);
- •Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation;
- •Patients with irreparable meniscal tears (i.e. multiple tears);
- •Subjects with full thickness cartilage defects greater than 10mm in diameter and/or serious defects;
- •Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury);
- •Performance of a significant concomitant procedure, specifically a cartilage repair or restoration (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee;
- •History of ipsilateral knee surgery, septic joint, or fracture;
- •Pathological conditions in the soft tissue that would prevent secure fixation of the device;
- •Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
- •The presence of infection;
- •Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
- •Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;
- •Patients who have an Ahlback grade greater than II;
- •Patients with a body mass index larger than 35;
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- •Meniscal Allograft Transplantation Exclusion Criteria:
- •Contraindications (per the FAST-FIX FLEX IFU) or hypersensitivity to the use of the FAST-FIX FLEX implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation;
- •Enrolled in the treatment period of another clinical trial within thirty (30) days of operative visit, or during the study;
- •Women who are pregnant or nursing;
- •Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (except for subjects aged sixteen (16) or seventeen (17) years of age with consent from their legally authorized representative);
- •Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation;
- •Patients with concomitant ligament injuries that do not require surgical repair (i.e. ACL with Grade 3 lateral collateral ligament (LCL) injury or medial collateral ligament (MCL) injury);
- •Performance of a significant concomitant procedure (excluding ACL reconstruction or repair, lateral extra-articular tenodesis, anterolateral ligament (ALL) reconstruction) intended as a therapeutic intervention on the study knee;
- •History of ipsilateral knee surgery, septic joint, or fracture (excluding MAT indication);
- •Pathological conditions in the soft tissue that would prevent secure fixation of the device;
- •Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing;
- •The presence of infection;
- •Conditions which would limit the patient's ability or willingness to restrict activities or follow directions during the healing period;
- •Malalignment: genu varus and genu valgus angles greater than 5° as evaluated by the patient's physician as per their standard of care;
- •Patients who have an Ahlback grade greater than II;
- •Patients with a body mass index larger than 35;
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
Meniscal Insufficiency
Subject requires a MAT for symptomatic meniscal insufficiency (load related pain and swelling in the compartment undergoing meniscectomy) for which conservative treatment has failed, with or without cartilage repair or restoration (including ACL reconstruction or repair).
干预措施: FAST-FIX FLEX Meniscal Repair System (Device)
Meniscal Tear
Subject requires a meniscus repair concerning the red-red or red-white zones for acute or chronic 1-, 2- or 3-segment lesions, with or without associated anterior cruciate ligament (ACL) reconstruction.
干预措施: FAST-FIX FLEX Meniscal Repair System (Device)
结局指标
主要结局
Reoperations at 12 Months
时间窗: 12 months
Count of participants with reoperations due to meniscal repair failure at 12 months postoperative. Failure was defined as revision surgery at the primary site of the tear.
次要结局
- Reoperations at 6 Months(6 months)
- Reoperations From Month 6 to Month 12(Month 6 to Month 12, approximately 6 months)
- Meniscal Healing by Meniscal Repair Status Grading(6 months and 12 months)
- Meniscal Healing by Meniscal Transplant Status Grading(6 months and 12 months)
- Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score(Pre-operatively, 6 months and 12 months)
- Patient Reported Outcome (PRO): Lysholm Score(Pre-operatively, 6 months and 12 months)
- Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L): Visal Analogue Scale (VAS) Score(Pre-operatively, 6 months and 12 months)
- Patient Reported Outcome (PRO): EuroQol 5 Dimension 5 Level (EQ-5D-5L): Health Score(Pre-operatively, 6 months and 12 months)