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Mini Stem Radiostereometric Analysis Study

NCT01064531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2020-04-09

Study results available
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Summary

The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations.

Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Conditions

  • Osteoarthritis, Hip

Interventions

DEVICE

MIS Femoral Neck Stem implant

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard McCalden, MD · London Health Science Center

  • Beate Hanson, MD, PhD · Vice President, Global Clinical Strategy and Global Clinical Operations

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2016-04-22
Completion
2016-04-22
FDA Device
Yes

Countries

  • Canada

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 NCT01064531 on ClinicalTrials.gov