Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

MicroPort Orthopedics Inc.1 site in 1 country121 target enrollmentJune 16, 2017

ConditionsJoint Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Joint Disease
Sponsor: MicroPort Orthopedics Inc.
Enrollment: 121
Locations: 1
Primary Endpoint: Component Survivorship
Status: Active, not recruiting
Last Updated: 3 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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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

June 16, 2017

End Date

June 2027

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MicroPort Orthopedics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•the specified combination of components were implanted in both
•all other aspects of the Inclusion/Exclusion Criteria are satisfied
•enrollment does not exceed the subject count specified in the Clinical Trial Agreement

Exclusion Criteria

•Subjects implanted with a metal-on-metal articulation
•Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA
•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 or having pending incarceration

Outcomes

Primary Outcomes

Component Survivorship

Time Frame: 10 years post-operative

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

Secondary Outcomes

Patient functional outcomes (hip specific)(2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit)
Patient functional outcomes (quality of life)(2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit)