Non-Interventional, Multicenter Bicontact® E PMCF Study

NCT ID: NCT03442855

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Degenerative Osteoarthritis Rheumatoid Arthritis Femoral Neck Fractures Femoral Head Necrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Indication for Bicontact E prosthesis THA
* Patients ≥ 18 years
* Patient not pregnant
* Written informed consent

Exclusion Criteria

\- Patients receiving a bipolar implantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Funabashi Orthopedic Hospital

Funabashi, , Japan

Site Status

Niigata Bandai Hospital

Niigata, , Japan

Site Status

Niigata Rinko Hospital

Niigata, , Japan

Site Status

Niigata Univ. Medical & Dental Hospital

Niigata, , Japan

Site Status

Saiseikai Niigata Second Hospital

Niigata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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AAG-O-H-1417

Identifier Type: -

Identifier Source: org_study_id

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