Mini Stem Radiostereometric Analysis Study

NCT ID: NCT01064531

Last Updated: 2020-04-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-04-22

Brief Summary

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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.

Detailed Description

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The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Conditions

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Osteoarthritis, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MIS Femoral Neck Stem

Subject will be randomized to either MIS or Synergy implant.

MIS Femoral Neck Stem implant

Intervention Type DEVICE

Synergy Hip System

Subject will be randomized to either Synergy or MIS implant.

MIS Femoral Neck Stem implant

Intervention Type DEVICE

Interventions

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MIS Femoral Neck Stem implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject has hip disease that requires a total hip arthroplasty.
* Subject is willing to consent to participation in the study.
* Subject plans to be available for follow-up through study duration.
* Subject is of stable health and is free of or treated and stabilized for any condition that would prose excessive operating risk.

Exclusion Criteria

* Subject has insufficient femoral bone stock.
* Subject has had major non-arthroscopic surgery to the study hip.
* Subject has physical, emotional or neurological conditions that would compromise the subjects compliance with postoperative rehabilitation and follow-up.
* Subject has a known sensitivity to materials in the device.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard McCalden, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Science Center

Beate Hanson, MD, PhD

Role: STUDY_CHAIR

Vice President, Global Clinical Strategy and Global Clinical Operations

Locations

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London Health Sciences Center- University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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US-CR-130

Identifier Type: -

Identifier Source: org_study_id

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