Collecting data on Exactech Hip Systems after surgery

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

This study is collecting information from people who have had or will have an Exactech Hip System to see how well it works and how safe it is after surgery.

Quick facts

• Study type: Observational
• Enrollment: 2946 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Exactech (Industry-sponsored)
• Locations: 1 site (Tulsa, Oklahoma)
• Trial ID: NCT05849961 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather clinical and patient outcomes data for individuals who have received or will receive an Exactech Hip System for total hip arthroplasty. It includes both prospective data collection from new patients and retrospective data from patients who have already undergone surgery. The study focuses on assessing the safety and effectiveness of these orthopedic devices in real-world settings. By analyzing this data, the study seeks to provide insights into the survivorship and performance of Exactech Hip Systems.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are scheduled to receive or have already received an Exactech Hip System for total hip arthroplasty.

Not a fit: Patients who have not received an Exactech Hip System or those who are not eligible for hip arthroplasty may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the long-term safety and effectiveness of Exactech Hip Systems, leading to improved patient outcomes.

How similar studies have performed: Other studies assessing post-market outcomes of orthopedic devices have shown success in improving device safety and effectiveness, making this approach both relevant and valuable.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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 this trial is running

Tulsa, Oklahoma

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

Study contacts

• Study coordinator: Pearl Harris

Conditions Hip Arthroplasty, Total