NCT05653102招募中不适用
CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Exactech5 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月23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
- 1,000
- 试验地点
- 5
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
研究概览
简要总结
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System
详细描述
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective / Subjects- Enrolled in the study pre-surgery
- •Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- •Skeletally mature (18 years of age or older).
- •Subject is willing and able to provide written informed consent for participation in the study.
- •Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
- •The knee replacement will be performed by the investigator or a surgeon sub-investigator.
- •The devices will be used according to the approved indications.
- •Retrospective to Prospective / Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.
- •Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).
- •Skeletally mature (18 years of age or older).
- •Subject is willing and able to provide written informed consent for participation in the study.
- •Subject received a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee.
- •The knee replacement was performed by the investigator or a surgeon sub-investigator.
- •The devices are/were used according to the approved indications.
- •Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission: Pre-Operative:
- •o Demographic Data
- •Age at surgery
- •Height/Weight
- •Indication for surgery
- •Prior Injuries/Surgeries on index knee
- •Comorbidities
- •Operative:
- •Date of Surgery
- •Type of Surgery (Primary / Revision)
- •All component product information, including catalogue reference numbers
- •Adverse Event Information, if applicable
- •Retrospective Only Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. Note: No prospective data may be collected from a subject if they are enrolled under this cohort unless the subject is willing and able to provide written informed consent for participation in the study.
- •Skeletally mature at the time of the surgery (18 years of age or older).
- •The patient's clinical record includes a signed HIPAA waiver allowing for the use of clinical record data for the purpose of clinical research outside of the operating institution.
- •The patients clinical record includes a documented procedure that includes, or is related to, TKA with a Truliant® Knee system device.
- •The knee replacement was performed by the investigator or a surgeon sub-investigator.
- •The devices are/were used according to the approved indications.
- •Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for submission:
- •Pre-Operative:
- •Demographic Data
- •Age at surgery
- •Height/Weight
- •Indication for surgery
- •Prior Injuries/Surgeries on index knee
- •Comorbidities
- •Operative:
- •Date of Surgery
- •Type of Surgery (Primary / Revision)
- •All component product information, including catalogue reference numbers Adverse Event Information, if applicable
排除标准
- •Patient was <18 years of age at time of surgery
- •Patient does not meet indicated population for use criteria for this device
- •Patient is pregnant
- •Patient is a prisoner
- •Patient has a physical or mental condition that would invalidate the results
- •Patient is contraindicated for the surgery (e.g., metal allergy)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR.
时间窗: 10 year
KOOS JR. - validated outcome score
Oxford Knee Score
时间窗: 10 year
OKS - validated outcome score
Visual Analog Scale (VAS) - Pain
时间窗: 10 year
Visual scale from 1-10 (high score is better)
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
不适用
Optetrak Knee System Post Market Clinical Follow-UpKnee Arthroplasty, TotalNCT05788757Exactech4,588
已完成
不适用
A Post-Market, Retrospective Study on 3D Metal Tibial and Femoral ConesTotal Knee ArthroplastyNCT06578897Medacta International SA118
已完成
不适用
Post-Market Study of the 3DKnee™ SystemDegenerative Joint DiseaseTraumatic ArthritisOsteoarthritisRheumatoid ArthritisNCT00819481Encore Medical, L.P.229
进行中（未招募）
不适用
JOURNEY II XR Safety and Effectiveness PMCFRheumatoid Vasculitis With Rheumatoid Arthritis of KneeUnilateral Post-Traumatic Osteoarthritis of KneeDegenerative Arthritis Peripheral JointKnee OsteoarthritisFailed OsteotomiesFailed Unicompartmental ReplacementNCT03136887Smith & Nephew, Inc.176
进行中（未招募）
不适用
Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™Degenerative Joint DiseaseNCT02380092Smith & Nephew, Inc.163