MFinity BE Pre-market Trial
ConditionTotal Hip Arthroplasty (THA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
The primary objective of this trial is to determine the implant survival at 1 year of follow up in a population of patients undergoing primary Total Hip Replacement with MFinity Collared Femoral stem and to test its non-inferiority compared to other cementless implant (as reported by the EPRD registry).
Eligibility criteria
Qualifiers
Patients undergoing elective primary total hip arthroplasty for primary osteoarthritis, who are suitable for implantation of a cementless femoral stem according to the MFinity femoral stem Instructions for Use
Skeletally mature adult aged 18 years and older at the time of enrollment.
Ability to give informed consent.
Patient is informed of the conditions of the study and is willing to participate for the length of the prescribed follow-up period.
Disqualifiers
Not meeting the inclusion criteria.
Active infection within the affected hip joint.
Previous total hip replacement or hip fusion of the affected hip joint.
Neuromuscular or neurosensory deficiency limiting the ability to evaluate the safety and effectiveness of the device.
Trial design
Treatments tested in this trial
- Mfinity collared stem
Treatment groups
95 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov