Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)

Официальное название

TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems

Обзор

A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems

Подробное описание

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).

Вмешательства

• Устройство Exactech Hip Systems
  The Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements.

Первичные конечные точки

• Harris Hip Score [Срок оценки: Preoperative]
• Harris Hip Score [Срок оценки: 4-6 week Post-op; per standard of care]
• Harris Hip Score [Срок оценки: 3-6 month Post-op; per standard of care]
• Harris Hip Score [Срок оценки: Annually up to 10 years; per standard of care]
• Oxford Hip Score [Срок оценки: Preoperative]
• Oxford Hip Score [Срок оценки: 4-6 week Post-op; per standard of care]
• Oxford Hip Score [Срок оценки: 3-6 month Post-op; per standard of care]
• Oxford Hip Score [Срок оценки: Annually up to 10 years; per standard of care]

Критерии участия

Критерии включения

Cohort 1:

• 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.

Cohort 2:

• 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

• Gender
• Age at surgery
• Height/Weight
• Indication for surgery
• Prior Injuries/Surgeries on index hip
• Comorbidities

Operative:

• Date of Surgery
• Type of Surgery (Primary / Revision)
• All component product information, including catalogue reference numbers.
• Adverse Event Information, if applicable

Cohort 3:

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 2.

• 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

• Gender
• Age at surgery
• Height/Weight
• Indication for surgery
• Prior Injuries/Surgeries on index hip
• Comorbidities

Operative:

• Date of Surgery
• Type of Surgery (Primary / Revision)
• All component product information, including catalogue reference numbers.
• Adverse Event Information, if applicable

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Tulsa Bone & Joint Associates — Tulsa

Идентификаторы

NCT: NCT05849961 · TM-2023-017318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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