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MFinity BE Pre-market Trial

NCT07616895 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-06-01

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Medacta International SA

    lead INDUSTRY

Principal Investigators

  • Frans-Jozef Vandeputte · Ziekenhuis Oost-Limburg AV, Synaps Park 1, B-3600 Genk, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616895 on ClinicalTrials.gov