Non-Interventional, Multicenter Bicontact® E PMCF Study

September 18, 2019 updated by: Aesculap AG
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Funabashi, Japan
        • Funabashi Orthopedic Hospital
      • Niigata, Japan
        • Niigata Bandai Hospital
      • Niigata, Japan
        • Niigata Rinko Hospital
      • Niigata, Japan
        • Niigata Univ. Medical & Dental Hospital
      • Niigata, Japan
        • Saiseikai Niigata Second Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving primary THA:

Acute disorders of the hip that cannot be treated by other therapies:

  • Degenerative osteoarthritis
  • Rheumatic arthritis
  • Joint fractures
  • Femoral head necrosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Patients receiving a bipolar implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Results
Time Frame: 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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thigh Pain
Time Frame: 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].
1 year
X-Ray evaluation
Time Frame: 1 year
Radiological results (osteointegration, migration)
1 year
(Serious) Adverse Events
Time Frame: 1 year
Complications: Adverse Events (AE) / Serious Adverse Events (SAE)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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