MedTrace Logo

A Prospective Multi-center Study on Total Hip Arthroplasty With E1

NCT01883492 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2020-02-17

Study results available
· View outcomes & findings →

Summary

The primary objectives of this clinical study include:

* Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
* Compare E1 wear used with CoCr and Biolox Delta heads

Conditions

  • Hip Osteoarthritis

Interventions

DEVICE

Femoral Stem

JMDN classification/Class III device

DEVICE

Acetabular Cup

JMDN classification: Class III device

DEVICE

Acetabular Liner

JMDN classification: Class III device

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hirotsugu Ohashi, M.D., Ph.D. · Saiseikai Nakatsu Hospital

  • Arihiko Kanaji, M.D., Ph.D. · Keio University

  • Katsufumi Uchiyama, M.D., Ph.D. · Kitasato University School of Medicine

  • Hironori Kaneko, M.D., Ph.D. · Kitasato University Kitasato Institute Hospital

  • Koichi Kinoshita, M.D., Ph.D. · Fukuoka University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-11
Primary Completion
2019-02-06
Completion
2019-03-15
FDA Device
Yes

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01883492 on ClinicalTrials.gov