Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

MicroPort Orthopedics Inc.1 site in 1 country63 target enrollmentJanuary 15, 2019

ConditionsJoint Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Joint Disease
Sponsor: MicroPort Orthopedics Inc.
Enrollment: 63
Locations: 1
Primary Endpoint: The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up.
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 Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Registry

clinicaltrials.gov

Start Date

January 15, 2019

End Date

January 1, 2032

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MicroPort Orthopedics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Subjects will be excluded if they meet any of the following criteria:
•Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners);
•Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck;
•Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery;
•Subjects have or had an overt infection at the time of implantation;
•Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation;
•Subjects have or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at time of implantation;
•Subjects have or had inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
•Subject has neuropathic joints;
•Subject has hepatitis or HIV infection;

Outcomes

Primary Outcomes

The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up.

Time Frame: 10 years

Percentage of hips survived with no revision or replacement at 10-year.

Secondary Outcomes

To determine the cumulative incidence of component revision of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck at specified intervals out to 10 years follow-up.(Time Frame: 2-5 years, 5-7 years, and 10 years)
To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores.(Time Frame: 2-5 years, 5-7 years, and 10 years)
To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components.(2-5 years, 5-7 years, and 10 years)
To characterize of adverse events and adverse device effects.(2-5 years, 5-7 years, and 10 years)