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LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study

NCT00510458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-03-12

Study results available
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Summary

Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.

Conditions

  • Arthroplasty, Replacement, Hip

Interventions

DEVICE

LFIT™ Femoral Heads With X3® Insert

LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Sponsors & Collaborators

  • Stryker Orthopaedics

    lead INDUSTRY

Principal Investigators

  • James D'Antonio, MD · Greater Pittsburgh Orthopaedic Associates

  • Stephen Thomas, M.D. · Greater Pittsburgh Orthopaedic Associates

  • Eric Smith, M.D. · Tufts University Medical Center

  • Arthur Mark, M.D. · Seaview Orthopaedic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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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 NCT00510458 on ClinicalTrials.gov