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MFinity BE Pre-market Trial

27. Mai 2026 aktualisiert von: Medacta International SA

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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

95

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Implant survival rate (%) assessed by Kaplan-Meier analysis at 1 year
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Implant survival rate (%) assessed by Kaplan-Meier analysis at 2 years
Zeitfenster: 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
Zeitfenster: Pre-op, 6 weeks, 3 months, 1 and 2 years

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)
Zeitfenster: Pre-op, 6 weeks, 3 months, 1 and 2 years
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
Zeitfenster: From surgery to 2 years post-operatively
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
Zeitfenster: From surgery to 2 years post-operatively
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
Zeitfenster: 3 months, 1 and 2 years postoperatively
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medacta International SA

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2028

Studienabschluss (Geschätzt)

1. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • P01.035.03

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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