Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

MicroPort

Status: Active, not recruiting

Conditions: Joint Disease

Treatments: Device: PROFEMUR® L Revision Femoral Stem

Study type: Observational

Funder types: Industry

Identifiers

NCT02314702

12-LJH-002L

Details and patient eligibility

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.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has undergone revision total hip arthroplasty
• Subject is implanted with the specified combination of components
• Subject is willing and able to complete required study visits or assessments

Exclusion criteria

• Subjects currently enrolled in another clinical study
• Subjects unwilling to sign the Informed Consent document
• Subjects with substance abuse issues
• Subjects who are incarcerated or have pending incarceration

Trial design

26 participants in 1 patient group

Revision Total Hip Arthroplasty

Description:

Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem

Treatment:

Device: PROFEMUR® L Revision Femoral Stem