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

MicroPort

Status: Active, not recruiting

Conditions: Joint Disease

Treatments: Device: Primary hip resurfacing device

Study type: Observational

Funder types: Industry

Identifiers

NCT02285842

12-LJH-002F

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.

Full description

MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Enrollment: 143 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

143 participants in 1 patient group

Primary Hip Resurfacings

Description:

Single study group previously implanted with CONSERVE® Press-Fit Femoral Components

Treatment:

Device: Primary hip resurfacing device