Exactech Hip Systems Post-Market Clinical Follow-up (PMCF)
ConditionHip Arthroplasty, Total
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorExactech
About this trial
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Gender
Age at surgery
Height/Weight
Indication for surgery
Trial population
Patients must qualify for surgery per indications and contraindications and meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the surgeon's discretion.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Exactech Hip Systems
DeviceThe 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.
Treatment groups
2,946 Participants
are divided into 3 treatment groupsGroup A: Prospective Subjects1 intervention
Group B: Retrospective to Prospective1 intervention
Group C: Retrospective Only Subjects1 intervention
Trial outcomes
Primary outcomes
1
Harris Hip Score
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.
Time frame
Preoperative2
Harris Hip Score
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.
Time frame
4-6 week Post-op; per standard of care3
Harris Hip Score
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.
Time frame
3-6 month Post-op; per standard of care4
Harris Hip Score
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.
Time frame
Annually up to 10 years; per standard of care Source ClinicalTrials.gov