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

3 april 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

160

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

55 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Harris Hip Total Score at 12 months postoperatively
Tidsram: 12 months postoperatively
12 months postoperatively

Sekundära resultatmått

Resultatmått
Tidsram
Ett års icke-revisionsfrekvens där revision definieras som avlägsnande av någon komponent sekundärt till infektion
Tidsram: 12 månader efter operationen
12 månader efter operationen
One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
Tidsram: 12 months postoperatively
12 months postoperatively

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Harris Hip Total Score success: success is ≥ 80 points.
Tidsram: 12 months postoperatively
12 months postoperatively
Patient Reported Outcomes
Tidsram: 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
Tidsram: Preoperation to 12 months postoperatively
Preoperation to 12 months postoperatively
Adverse Events: tally the type and frequency of adverse events
Tidsram: Preoperation to 12 months postoperatively
Preoperation to 12 months postoperatively

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johnson & Johnson Medical (Suzhou) Ltd.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 juni 2015

Primärt slutförande (Faktisk)

4 december 2017

Avslutad studie (Faktisk)

17 januari 2018

Studieregistreringsdatum

Först inskickad

20 mars 2015

Först inskickad som uppfyllde QC-kriterierna

25 mars 2015

Första postat (Uppskatta)

26 mars 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 april 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 april 2018

Senast verifierad

1 april 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • DPS-201301

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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