Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

A Prospective Multi-center Study on Total Hip Arthroplasty With E1

3. Februar 2020 aktualisiert von: Zimmer Biomet

A Prospective Multi-center Randomized Study on Total Hip Replacement With E1

The primary objectives of this clinical study include:

  • Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
  • Compare E1 wear used with CoCr and Biolox Delta heads

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.

Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.

Randomization will occur via random number generator by 4 blocks randomization.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

153

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Japan
      • Osaka, Japan, 530-0012
        • Saiseikai Nakatsu Hospital
      • Tokyo, Japan, 160-8582
        • Keio University School of Medicine
      • Tokyo, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
    • Fukuoka Prefecture
      • Fukuoka city, Fukuoka Prefecture, Japan, 814-0180
        • Fukuoka University School of Medicine
    • Kanagawa Prefecture
      • Sagamihara City, Kanagawa Prefecture, Japan, 252-0374
        • Kitasato University School of Medicine

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

20 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • Osteoarthritis
  • Age between 20 - 75 at the time of operation
  • Patients with limited co-morbidity -ASA I-III
  • Patients must be able to understand instructions and be willing to return for follow up

Exclusion Criteria:

  • In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.

Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

  1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. osteoporosis,
  3. metabolic disorders which may impair bone formation,
  4. osteomalacia,
  5. distant foci of infections which may spread to the implant site,
  6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
  7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
  8. pregnancy

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: BIOLOX delta head

Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).

Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.

Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Gerät: Femoral Stem
JMDN classification/Class III device
Andere Namen:
  • Taperloc Complete
  • Taperloc Microplasty Complete
  • Taperloc Complete XR123
  • Taperloc Microplasty Complete XR123
Gerät: Acetabular Cup
JMDN classification: Class III device
Andere Namen:
  • Ringloc Acetabular Cup
  • Regenerex Ringloc+ Acetabular Cup
Gerät: Acetabular Liner
JMDN classification: Class III device
Andere Namen:
  • E1 Ringloc Liner
Aktiver Komparator: CoCr head

Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).

Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.

CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Gerät: Femoral Stem
JMDN classification/Class III device
Andere Namen:
  • Taperloc Complete
  • Taperloc Microplasty Complete
  • Taperloc Complete XR123
  • Taperloc Microplasty Complete XR123
Gerät: Acetabular Cup
JMDN classification: Class III device
Andere Namen:
  • Ringloc Acetabular Cup
  • Regenerex Ringloc+ Acetabular Cup
Gerät: Acetabular Liner
JMDN classification: Class III device
Andere Namen:
  • E1 Ringloc Liner

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
Zeitfenster: Immediate postoperative and 2 year postoperatively
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
Immediate postoperative and 2 year postoperatively

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Harris Hip Score at 6 Month Follow-up Visit
Zeitfenster: 6 month postoperative

Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
6 month postoperative
Harris Hip Score at 1 Year Follow-up Visit
Zeitfenster: 1 year postoperative

Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
1 year postoperative
Harris Hip Score at 2 Year Follow-up Visit
Zeitfenster: 2 year postoperative

Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
2 year postoperative
Harris Hip Score at 3 Year Follow-up Visit
Zeitfenster: 3 year postoperative

Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
3 year postoperative
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
Zeitfenster: 6 month postoperative

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
6 month postoperative
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
Zeitfenster: 1 year postoperative

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
1 year postoperative
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
Zeitfenster: 2 year postoperative

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
2 year postoperative
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
Zeitfenster: 3 year postoperative

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
3 year postoperative
UCLA Activity Score at 6 Month Follow-up Visit
Zeitfenster: 6 month postoperative

University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
6 month postoperative
UCLA Activity Score at 1 Year Follow-up Visit
Zeitfenster: 1 year postoperative

University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
1 year postoperative
UCLA Activity Score at 2 Year Follow-up Visit
Zeitfenster: 2 year postoperative

University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
2 year postoperative
UCLA Activity Score at 3 Year Follow-up Visit
Zeitfenster: 3 year postoperative

University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
3 year postoperative

Mitarbeiter und Ermittler

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

Sponsor

Zimmer Biomet

Ermittler

  • Hauptermittler: Hirotsugu Ohashi, M.D., Ph.D., Saiseikai Nakatsu Hospital
  • Hauptermittler: Arihiko Kanaji, M.D., Ph.D., Keio University
  • Hauptermittler: Katsufumi Uchiyama, M.D., Ph.D., Kitasato University School of Medicine
  • Hauptermittler: Hironori Kaneko, M.D., Ph.D., Kitasato University Kitasato Institute Hospital
  • Hauptermittler: Koichi Kinoshita, M.D., Ph.D., Fukuoka University School of Medicine

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 (Tatsächlich)

11. März 2013

Primärer Abschluss (Tatsächlich)

6. Februar 2019

Studienabschluss (Tatsächlich)

15. März 2019

Studienanmeldedaten

Zuerst eingereicht

31. Januar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juni 2013

Zuerst gepostet (Schätzen)

21. Juni 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Februar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Februar 2020

Zuletzt verifiziert

1. Februar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • INT.CR.GH2

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

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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 .

Klinische Studien zur Hüftarthrose

Klinische Studien zur Femoral Stem

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Mexico

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren