Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

MicroPort Orthopedics Inc.1 site in 1 country143 target enrollmentMarch 27, 2019

ConditionsJoint Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Joint Disease
Sponsor: MicroPort Orthopedics Inc.
Enrollment: 143
Locations: 1
Primary Endpoint: Component Survivorship
Status: Enrolling By Invitation
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) 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 Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Registry

clinicaltrials.gov

Start Date

March 27, 2019

End Date

December 2032

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MicroPort Orthopedics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To be included in the study, subjects must meet all of the following criteria:
•Has previously undergone primary Total Hip Arthroscopy 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;
•Correction of functional deformity
•Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
•Subject is willing and able to complete required study visits or assessments
•Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:
•the specified combination of components were implanted in both,
•all other aspects of the Inclusion/Exclusion Criteria are satisfied,

Exclusion Criteria

•Subjects will be excluded if they meet any of the following criteria:
•Subject was skeletally immature (less than 21 years of age) at time of implantation
•Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
•Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
•Subject is unwilling or unable to sign the Informed Consent document
•Subject has documented substance abuse issues
•Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
•Subject is currently incarcerated or has impending incarceration

Outcomes

Primary Outcomes

Component Survivorship

Time Frame: 10 years post-operative

The primary endpoint is to evaluate component survivorship of the PROCOTYL® C Acetabular Components out to 10 years follow-up. Percentage of hips survived with no revision or replacement at 10-year.

Secondary Outcomes

To determine the cumulative incidence of component revision at specified intervals out to 10 years follow-up;(2-5 years, 5-7 years, and 10 years)
To characterize functional scores, as assessed by Oxford Hip.(2-5 years, 5-7 years, and 10 years)
To characterize functional scores, as assessed by EQ-5D-3L scores.(2-5 years, 5-7 years, and 10 years)