Clinical Trials in the USA / NCT05849961
Recruiting
Observational
Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)
NCT05849961 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Hip Arthroplasty, Total
Investigational drug(s) / intervention(s)
Exactech Hip Systems
Exactech 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.
Study summary
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Eligibility
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)
Primary outcome measure(s)
- 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. - Harris Hip Score — 4-6 week Post-op; 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. - Harris Hip Score — 3-6 month Post-op; 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. - 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 — 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. - Oxford Hip Score — 4-6 week Post-op; 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. - Oxford Hip Score — 3-6 month Post-op; 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. - 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 sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tulsa Bone & Joint Associates | Tulsa | Oklahoma | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05849961 on ClinicalTrials.gov ↗ ← All trials in the USA