Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

About this trial

Last updated 3 years ago

Study ID

12-LJH-002F

Status

Active not recruiting

Type

Observational

Placebo

Accepting

21+ Years

All Sexes

Trial Timing

Started 12 years ago

What is this trial about?

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.

What are the participation requirements?

Inclusion Criteria

* Has undergone primary hip resurfacing 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 resurfacing 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 have pending incarceration