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Non-Interventional, Multicenter Bicontact® E PMCF Study

Sponsor
Aesculap AG (Industry)
Overall Status
Completed
CT.gov ID
NCT03442855
Collaborator
(none)
73
Enrollment
5
Locations
27.9
Actual Duration (Months)
14.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers in Japan to collect short term clinical and radiological results of the cementless Bicontact® E stem in a standard patient population used in routine clinical practice

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    73 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-Interventional, Multicenter Bicontact® E PMCF Study
    Actual Study Start Date :
    Feb 1, 2017
    Actual Primary Completion Date :
    May 31, 2018
    Actual Study Completion Date :
    May 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Results [1 year]

      Hip Score of the Japanese Orthopaedic Association (JOA): three categories-movement, mental, and pain-each comprising 7 items, for a total of 21 items to be used as evaluation criteria for hip-joint function

    Secondary Outcome Measures

    1. Thigh Pain [1 year]

      Pain as measured with the Visual Analog Scale (VAS): Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal analog scale of 100 mm length. It is anchored by two verbal descriptors, one for each symptom extreme [no pain - worst imaginable pain].

    2. X-Ray evaluation [1 year]

      Radiological results (osteointegration, migration)

    3. (Serious) Adverse Events [1 year]

      Complications: Adverse Events (AE) / Serious Adverse Events (SAE)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Indication for Bicontact E prosthesis THA

    • Patients ≥ 18 years

    • Patient not pregnant

    • Written informed consent

    Exclusion Criteria:
    • Patients receiving a bipolar implantation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Funabashi Orthopedic Hospital Funabashi Japan
    2 Niigata Bandai Hospital Niigata Japan
    3 Niigata Rinko Hospital Niigata Japan
    4 Niigata Univ. Medical & Dental Hospital Niigata Japan
    5 Saiseikai Niigata Second Hospital Niigata Japan

    Sponsors and Collaborators

    • Aesculap AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aesculap AG
    ClinicalTrials.gov Identifier:
    NCT03442855
    Other Study ID Numbers:
    • AAG-O-H-1417
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Sep 19, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aesculap AG
    Arthroplasty, Replacement, Hip
    Additional relevant MeSH terms:
    Osteoarthritis
    Necrosis
    Femoral Neck Fractures

    Study Results

    No Results Posted as of Sep 19, 2019