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Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components

NCT ID: NCT02668211

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-12-31

Brief Summary

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MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.

Detailed Description

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Conditions

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Joint Disease Osteoarthritis

Keywords

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osteoarthritis radiostereometric analysis correction of functional deformity procedures total hip arthroplasty musculoskeletal diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PROFEMUR Preserve RSA

Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components

Group Type OTHER

PROFEMUR Preserve Classic Femoral Components

Intervention Type DEVICE

Interventions

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PROFEMUR Preserve Classic Femoral Components

Intervention Type DEVICE

Other Intervention Names

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Total Hip Arthroplasty System

Eligibility Criteria

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Inclusion Criteria

* Subject is a candidate for primary THA for osteoarthritis
* Subject is able to undergo primary THA procedure
* Subject is a candidate to be implanted with the specified combination of components
* Subject is willing and able to complete required study visits and assessments
* Subject is willing to sign the approved Informed Consent document

Exclusion Criteria

* Subject has any of the following contraindications at the time of the implantation:
* Overt infection;
* Distant foci of infections (which may cause hematogenous spread to the implant site);
* Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram;
* Skeletally immature (less than 21 years of age at time of surgery);
* Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
* Subjects 76 years of age or older
* Subjects with post-traumatic arthritis in the affected hip
* Subjects with rheumatoid arthritis in the affected hip
* Subjects with hip dysplasia in the affected hip
* Subjects with prior arthroplasty of the affected hip
* Subjects that are morbidly obese (BMI \> 35)
* Subjects that are immuno-suppressed
* Subjects with known or tested-positive allergy to metals
* Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol
* Subjects unwilling or unable to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
Minimum Eligible Age

21 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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14LJH002

Identifier Type: -

Identifier Source: org_study_id