MFinity BE Pre-market Trial

NCT07616895 | Not Yet Recruiting

• 1 other identifier: P01.035.03
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Total Hip Arthroplasty (THA)

Outcome Measures

Primary Outcomes (1)

• Implant survival rate (%) assessed by Kaplan-Meier analysis at 1 year

  The survival rate according to a Kaplan Meier curve. The Kaplan-Meier method calculates the survival of the prosthesis by measuring the fraction of living subjects during a period after the procedure. Each time an expected event occurs (revision of the prosthesis, patients lost to follow-up, death, etc.), the probability of implant survival changes. This information is used to estimate the performance of the prosthesis. During the study, the number of stem revisions and the number of patients who died or were lost to follow-up will be collected to calculate the probability of survival. The time of occurrence will be recorded for each event.

  1 year

Secondary Outcomes (6)

• Implant survival rate (%) assessed by Kaplan-Meier analysis at 2 years

  2 years

• Harris Hip Score

  Pre-op, 6 weeks, 3 months, 1 and 2 years

• Forgotten Joint Score-12 (FJS-12)

  Pre-op, 6 weeks, 3 months, 1 and 2 years

• Incidence of device deficiencies

  From surgery to 2 years post-operatively

• Incidence of adverse events and serious adverse events

  From surgery to 2 years post-operatively

Study Arms (1)

Single-Arm

EXPERIMENTAL

Patients suitable to receive Medacta Mfinity collared sted for primary THA will be invited to take part to the study during the preoperative visit. Follow-ups are performed after 6 week, 3, 12 and 24 months. Data collection includes clinical and radiological data for preoperative and postoperative assessments, as well as intraoperative details.

Device: Mfinity collared stem

Interventions

Mfinity collared stem DEVICE

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.

Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Officials

• Frans-Jozef Vandeputte

  Ziekenhuis Oost-Limburg AV, Synaps Park 1, B-3600 Genk, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Vigano'

CONTACT

+41 91 696 60 60; myclinicaldata@medacta.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share