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NOT YET RECRUITING

NCT07616895

MFinity BE Pre-market Trial

Sponsor: Medacta International SA

View on ClinicalTrials.gov

Summary

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).

Official title: Prospective Single-arm Clinical Study Assessing the Safety and Effectiveness of a Novel Femoral Stem for Total Hip Arthroplasty.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06

Completion Date

2029-06

Last Updated

2026-06-01

Healthy Volunteers

Conditions

Total Hip Arthroplasty (THA)

Interventions

DEVICE

Mfinity collared stem

The MFinity Femoral Stem is intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The devices are made of Ti6Al7Nb and coated in the proximal end of the shaft with TiGrowth-C titanium. The thickness of the Ti coating is 700μm while the thickness of the HA coating is 80μm.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.