Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems

MicroPort Orthopedics Inc.1 site in 1 country154 target enrollmentDecember 2014

ConditionsJoint Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Joint Disease
Sponsor: MicroPort Orthopedics Inc.
Enrollment: 154
Locations: 1
Primary Endpoint: Component Survivorship
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

November 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MicroPort Orthopedics Inc.

Responsible Party

Sponsor

Eligibility Criteria

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
•Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria

•Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
•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

Outcomes

Primary Outcomes

Component Survivorship

Time Frame: 10 years post-operative

The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.

Secondary Outcomes

Patient functional outcomes (hip specific)(5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval)
Patient functional outcomes (quality of life)(5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval)