MultiCenter Prospective Parallel Registry Controlled Investigational Device Exemption Clinical Study to Determine Non-Inferiority of the PEEK-OPTIMA™ Femoral Component Versus a CoCr Alloy Femoral Component of Similar Design for TKA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Original Knee Society Score
研究概览
简要总结
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).
详细描述
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).
PEEK is a high-performance, engineering thermoplastic characterized by an unusual combination of properties. These properties range from high temperature performance to mechanical strength and excellent chemical resistance.
The PEEK-OPTIMA® femoral component, is an investigational device and is the subject of this study approved for IDE by the Federal Food and Drug Administration (FDA).
Maxx Orthopedics, Freedom Total Knee System is used with instrumentation to assist with surgery of the knee. The Maxx Orthopedics, Freedom Total Knee System implants are approved by the FDA for use in the United States and is not investigational.
All patients will receive the Freedom Total Knee System with the PEEK femoral component. Patient / study participents' records will be reviewed for identification of any and all complications, post-operative care, component safety and efficacy, and if re-operation is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 years of age or older.
- •Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
- •Subjects with a pre-operative Knee Society Score (KSS) Knee score of >25 and <
- •Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last 6 months.
- •Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).
- •Subjects with known osteoporosis and/or previous history of fracture related to osteoporosis.
- •Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.
- •Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.
- •Subjects who have a neuromuscular or neurosensory deficit.
- •Female subjects who are pregnant or lactating.
- •Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
- •Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
- •Subjects with a fixed flexion deformity of over 20 degrees.
- •Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
- •Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.
- •Subjects that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.
- •Evidence of active or suspected (systemic or local) infection at time of surgery.
研究组 & 干预措施
Treatment arm utilizing primary TKA with PEEK femoral component
This study is a single arm, multi-center, prospective IDE trial. Two hundred (200) patients recruited and consented will receive the PEEK-OPTIMA™ Femoral Component and results will be compared to matched historic controls from the Maxx Orthopedics Freedom Total Knee System product registry (PK-00002 REV-01, WCG IRB# 20241890). Male and female patients 18 years of age or older with Knee Society Score (KSS) of >25 and <75 will be eligible for enrollment.
干预措施: Total Knee Arthroplasty (Device)
结局指标
主要结局
Original Knee Society Score
时间窗: 24 months post-treatment.
The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices. The Knee Society Score is usually reported as the two scores, "Knee Score" and "Function Score," rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).
次要结局
- Knee Society Score (Knee Scores)(Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment)
- Knee Society Score (Function Scores)(Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment)
- Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)(• Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment)
- The Patient Reported Outcomes Measurement Information System (PROMIS) Global-10(• Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment)
- Visual-Analog Scale (VAS) score(Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment)
- Forgotten Joint Score (FJS-12)(Subject reported outcomes at 3-6 weeks 3-, 6-, 12- and 24-months post-treatment)