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

Recruiting

• Conditions: Hip Arthroplasty, Total
• Interventions: Device: Exactech Hip Systems

• Registration Number: NCT05849961
• Lead Sponsor: Exactech

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-09
• Study Start: 2023-10-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2036-07-31
• Study Completion: 2036-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2946

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Subjects	Exactech Hip Systems	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.
Retrospective to Prospective	Exactech Hip Systems	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).
Retrospective Only Subjects	Exactech Hip Systems	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.

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	Annually up to 10 years; per standard of care	Harris Hip Score (HHS) - validated outcome score. Scores range from 0 (worse disability) to 100 (less disability). The HHS will be collected throughout the duration of the implanted device according to standard of care.
Oxford Hip Score	Annually up to 10 years; per standard of care	Oxford Hip Score (OHS) - validate outcome score. Scores range from score 0 (most severe symptoms, to 48 (least symptoms). The OHS will be collected throughout the duration of the implanted device according to standard of care.

Trial Locations

Locations (1)

Tulsa Bone & Joint Associates; 🇺🇸 Tulsa, Oklahoma, United States