MFinity BE Pre-market Trial

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Total Hip Arthroplasty (THA)
• Intervention / Treatment: Device: Mfinity collared stem

Detailed Description

This prospective study aims to assess the clinical and radiographic outcomes of patients undergoing THA with implantation of MFinity femoral stems to determine the safety and performance of the implant in comparison with registry data for uncemented THA.

Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.

The study is conducted according to the following schedule:

• V1 : Inclusion during a preoperative visit
• V2: Surgery
• V3: Follow-up visit at 6 week post-surgery
• V4: Follow-up visit at 3 months post-surgery
• V5: Follow-up visit at 12 months post-surgery
• V6: Follow-up visit at 24 months post-surgery

The following data will be collected:

• Rate of complications, Device Deficiencies and Adverse Events
• HHS and FJS at 6 weeks, 3 months, 1 and 2 years postoperatively
• Radiologic evaluations at immediate postoperative assessment, 3 months, 1 and 2 years postoperatively

A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).

The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Vigano'; Phone Number: +41 91 696 60 60; Email: myclinicaldata@medacta.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival rate (%) assessed by Kaplan-Meier analysis at 2 years	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.	2 years
Harris Hip Score	Evaluation of the Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility, stability and deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria. The usefulness of this score has been studied to estimate the clinical results after THR, it is a reference score in the field of orthopedics. The Harris hip score is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain).	Pre-op, 6 weeks, 3 months, 1 and 2 years
Forgotten Joint Score-12 (FJS-12)	Evaluation of the Forgotten Joint Score TheForgotten Joint Score-12 (FJS-12) is a patient-reported outcome measure assessing patients' awareness of the artificial joint during activities of daily living. The questionnaire consists of 12 items, each scored on a 5-point Likert scale (0 = never aware, 4 = mostly aware). Raw scores are summed and linearly transformed to a 0-100 scale, with higher scores indicating less joint awareness and therefore a better outcome.	Pre-op, 6 weeks, 3 months, 1 and 2 years
Incidence of device deficiencies	Number of device deficiencies reported during the study. Device deficiencies will be documented by the investigator using the dedicated device deficiency reporting form.	From surgery to 2 years post-operatively
Incidence of adverse events and serious adverse events	Number and percentage of adverse events (AEs) and serious adverse events (SAEs). Events will be recorded by the investigator on the AE/SAE reporting form, classified for seriousness, severity, causality with the device and/or procedure, and outcome.	From surgery to 2 years post-operatively
Radiological analysis	Proportion (%) of radiographic findings (including radiolucent lines, stem subsidence, stem tilt, cup migration, endosteal cavitations, ectopic ossification, and signs of loosening, migration or osteointegration) assessed qualitatively and/or semi-quantitatively on standard anteroposterior (AP) and lateral hip radiographs, per standard of care. Findings will be reported descriptively at each time point.	3 months, 1 and 2 years postoperatively

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Frans-Jozef Vandeputte, Ziekenhuis Oost-Limburg AV, Synaps Park 1, B-3600 Genk, Belgium

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: P01.035.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No