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

3. april 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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

Studietype

Intervensjonell

Registrering (Faktiske)

160

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Total Hip System made in China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China
Enhet: 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
Enhet: 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)

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Ett års ikke-revisjonsrate der revisjon er definert som fjerning av enhver komponent sekundært til infeksjon
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Medical (Suzhou) Ltd.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. juni 2015

Primær fullføring (Faktiske)

4. desember 2017

Studiet fullført (Faktiske)

17. januar 2018

Datoer for studieregistrering

Først innsendt

20. mars 2015

Først innsendt som oppfylte QC-kriteriene

25. mars 2015

Først lagt ut (Anslag)

26. mars 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. april 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DPS-201301

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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