Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)
NCT ID: NCT05849961
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2946 participants
OBSERVATIONAL
2023-10-13
2036-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
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.
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).
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.
Retrospective Only Subjects
Subjects enrolled in the study post-study surgery with no intent to continue as prospective subjects. 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
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.
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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Exactech
INDUSTRY
Responsible Party
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Locations
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Tulsa Bone & Joint Associates
Tulsa, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TM-2023-017318
Identifier Type: -
Identifier Source: org_study_id
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