PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

MicroPort

Status: Withdrawn

Conditions: Joint Disease

Treatments: Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell

Study type: Observational

Funder types: Industry

Identifiers

NCT02507258

12-LJH-002K

Details and patient eligibility

About

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) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subject 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

Exclusion criteria

• Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
• Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
• 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

Trial design

0 participants in 1 patient group

PROFEMUR® Am Femoral Stem

Description:

Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component

Treatment:

Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell