RecruitingNCT05849961

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

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

Sponsor

Exactech

Enrollment

2,946 participants

Start Date

Oct 13, 2023

Study Type

OBSERVATIONAL

Conditions

Hip Arthroplasty, Total

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria47

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.
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 Criteria6

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)

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Interventions

DEVICEExactech 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.