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Evaluation of Stability of Two Uncemented Hip Implants Used for Total Hip Arthroplasty

NCT02656771 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-02-25

No results posted yet for this study

Summary

The purpose of this study is to measure quantitatively the implant stability and implant related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric® Full proximal Profile total hip arthroplasty (THA) stem, and compare it to the classical uncemented Bi-Metric® Porous Primary THA stem by measuring migration of the stem assessed by model-based radiosteriometric analysis (MB-RSA) and measuring the periprosthetic adaptive bone remodeling assessed by dual-energy x-ray absorptiometry (DXA).

Conditions

  • Osteoarthritis, Hip

Interventions

DEVICE

Echo Bi-Metric

The insertion of the Echo® Bi-Metric® THA stem

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    collaborator OTHER

  • Zimmer Biomet

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Michael M Petersen, Professor · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-07-31
Completion
2022-12-31

Countries

  • Denmark

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 NCT02656771 on ClinicalTrials.gov