PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

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WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-31

Study Completion Date

2028-12-31

Brief Summary

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MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (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 the medial device directives (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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PROFEMUR® Am Femoral Stem

Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component

PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell

Intervention Type DEVICE

PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component

Interventions

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PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell

PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subject has undergone primary THA for any of the following:

* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria

* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or having pending incarceration

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No