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A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China

3. april 2018 opdateret af: Johnson & Johnson Medical (Suzhou) Ltd.

A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China

A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of China

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • The first affiliated hospital of Guangzhou Tranditional Meidical University
    • Hebei
      • Shijiazhuang, Hebei, Kina
        • The third affiliated hospital of Hebei University
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • The second affiiliated hospital of Harbin Medical University
    • Jiangxi
      • Nanchang, Jiangxi, Kina
        • The First Affiliated Hospital of Nanchang University
    • Ningxia
      • Yinchuan, Ningxia, Kina
        • The affiliated hosoital of Ningxia Medical University
    • Xinjiang
      • Hohhot, Xinjiang, Kina
        • The First Affiliated Hospital of Xinjiang Medicine University
    • Yunnan
      • Kunming, Yunnan, Kina
        • The general hospital of Kunming
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • The Second Affiliated Hospital of Zhejiang Medicine University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. The subject is ≥55, and ≤80 years old
  2. The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
  3. Subject is a suitable candidate for primary total hip replacement using the devices described in this CIP
  4. Subject must meet all criteria specified in BOTH SUN hip stem and Summit hip stem instructions for use (IFU)
  5. Before surgery, subject is willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB).
  6. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  7. Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the patient reported outcomes (PROs) in the CIP.
  8. Subject is receiving a unilateral hip replacement or, if a contralateral hip replacement is anticipated, the surgery must occur within 6 months of the first study hip. The second hip will not be enrolled in the study.

Exclusion Criteria:

  1. Subject does not provide written voluntary consent to participate in the clinical study.
  2. The Subject is a woman who is pregnant or lactating.
  3. Subjects who have undergone THA in contralateral hip within the past 6 months.
  4. Contralateral hip has been enrolled in the study.
  5. Presence of any previous prosthetic hip replacement device in affected hip.
  6. Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the affected hip
  7. Subject has hip dysplasia CROWE classification grade of 3 or 4.
  8. Above knee amputation of either contralateral or ipsilateral leg
  9. Subject is anticipated to require a contralateral THA between 6 months and 1-year.
  10. Subject has an active infection
  11. Subject has a malignant disease, severe condition, alcohol or drug addiction and/or mental disorders that the investigator believes will interfere with the study participation.
  12. Subjects with severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor in the bone surrounding the hip joint that, in the opinion of the investigator, will negatively impact implant fixation and the outcome of the investigation;
  13. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease).
  14. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  15. Subject has a medical condition with less than 2 years of life expectancy due to other medical conditions.
  16. The patient has comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
  17. The patient is currently participating in another investigational drug or device study.
  18. Subject is a prisoner.
  19. Subject has a known allergy to any component of the implant (metal for example).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Total Hip System made in China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China
Enhed: Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)
SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
Aktiv komparator: Total Hip System made outside of China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China
Enhed: Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Harris Hip Total Score at 12 months postoperatively
Tidsramme: 12 months postoperatively
12 months postoperatively

Sekundære resultatmål

Resultatmål
Tidsramme
Et års ikke-revisionsrate, hvor revision er defineret som fjernelse af enhver komponent sekundært til infektion
Tidsramme: 12 måneder postoperativt
12 måneder postoperativt
One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
Tidsramme: 12 months postoperatively
12 months postoperatively

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Harris Hip Total Score success: success is ≥ 80 points.
Tidsramme: 12 months postoperatively
12 months postoperatively
Patient Reported Outcomes
Tidsramme: Preoperation to 12 months postoperatively
SF 12: scores at 1 yr, change from pre-op. WOMAC: scores at 1 yr., change from pre-op.
Preoperation to 12 months postoperatively
Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis
Tidsramme: Preoperation to 12 months postoperatively
Preoperation to 12 months postoperatively
Adverse Events: tally the type and frequency of adverse events
Tidsramme: Preoperation to 12 months postoperatively
Preoperation to 12 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johnson & Johnson Medical (Suzhou) Ltd.

Efterforskere

  • Ledende efterforsker: Shigui Yan, The Second Affiliated Hospital of Zhejiang Medicine University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juni 2015

Primær færdiggørelse (Faktiske)

4. december 2017

Studieafslutning (Faktiske)

17. januar 2018

Datoer for studieregistrering

Først indsendt

20. marts 2015

Først indsendt, der opfyldte QC-kriterier

25. marts 2015

Først opslået (Skøn)

26. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DPS-201301

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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