NCT05849961招募中不适用
TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Exactech1 个研究点 分布在 1 个国家目标入组 2,946 人开始时间: 2023年10月13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
- 2,946
- 试验地点
- 1
- 主要终点
- Harris Hip Score
研究概览
简要总结
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
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 an Exactech Hip System for total hip arthroplasty (THA) 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
- Other
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
- •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).
- •The subject is willing and able to provide written informed consent for participation in the study.
- •Subject is to receive an Exactech Hip System THA for any approved indication for use.
- •The hip replacement will be performed by the investigator or a surgeon sub- investigator.
- •The devices will be used according to the approved indications.
- •Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will be collected from the subject's medical record for the time-period prior to enrollment in the study containing data pertaining to the preoperative time period and 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).
- •The subject is willing and able to provide written informed consent for participation in the study.
- •Subject received an Exactech Hip System THA for any approved indication for use.
- •The hip 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 Exactech Hip System 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:
- •Demographic Data
- •Age at surgery
- •Height/Weight
- •Indication for surgery
- •Prior Injuries/Surgeries on index hip
- •Comorbidities
- •Date of Surgery
- •Type of Surgery (Primary / Revision)
- •All component product information, including catalogue reference numbers.
- •Adverse Event Information, if applicable
- •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, in which case they should be part of Cohort
- •Skeletally mature (18 years of age or older).
- •The subject is willing and able to provide written informed consent for participation in the study.
- •Subject received an Exactech Hip System THA for any approved indication for use.
- •The hip 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 Exactech Hip System 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:
- •Demographic Data
- •Age at surgery
- •Height/Weight
- •Indication for surgery
- •Prior Injuries/Surgeries on index hip
- •Comorbidities
- •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 the 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
Harris Hip Score
时间窗: Annually up to 10 years; per standard of care
Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Oxford Hip Score
时间窗: Annually up to 10 years; per standard of care
Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.
次要结局
未报告次要终点
研究者
研究点 (1)
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