MFinity BE Pre-market Trial

Starting soon · Not applicable

Conditions studied: Total Hip Arthroplasty (THA)

In brief

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).

Key facts

Study ID

NCT07616895

Run by

Medacta International SA

People needed

95

Starts

2026-06-01

Expected to finish

2029-06-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Bone condition that may compromise the stability of the implant
• Known allergy or hypersensitivity to the implant material
• Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
• For women of childbearing potential*: a positive pregnancy test
• Patients with severe osteoarthritis in the contralateral hip or other joints that may interfere with the assessment of study outcomes.
• Patients who have previously participated in this clinical trial.
• a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women using one of the following birth control methods are not considered of childbearing potential: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable),intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.

Full record on ClinicalTrials.gov

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