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

Recruiting now

Conditions studied: Hip Arthroplasty, Total

In brief

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

Key facts

Study ID

NCT05849961

Run by

Exactech

People needed

2946

Starts

2023-10-13

Expected to finish

2036-12-31

Last updated by the study team

2024-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Tulsa Bone & Joint Associates — Tulsa, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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