Hip Arthroplasty, Total
Conditions
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).
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.
Sponsors
Exactech
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | Preoperative | 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 | Preoperative | 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. |
Countries
United States
Contacts
Primary ContactPearl Harris
Backup ContactAlex Knisely
Outcome results
None listed