Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

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

ACTIVE_NOT_RECRUITING

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-04

Study Completion Date

2027-10-31

Brief Summary

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MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

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Detailed Description

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Conditions

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Joint Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Revision Total Hip Arthroplasty

Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem

PROFEMUR® L Revision Femoral Stem

Intervention Type DEVICE

Revision Total Hip Arthroplasty

Interventions

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PROFEMUR® L Revision Femoral Stem

Revision Total Hip Arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Hip Revision Device

Eligibility Criteria

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Inclusion Criteria

* Has undergone revision total hip arthroplasty
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria

* Subjects currently enrolled in another clinical study
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No