Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- MicroPort Orthopedics Inc.
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Component Survivorship
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Component Survivorship
Time Frame: 10 years post-operative
The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.
Secondary Outcomes
- Component alignment(Screening (First Available), 2-5 years, 5-7 years, and 10 years)
- Patient functional outcomes(Screening (First Available), 2-5 years, 5-7 years, and 10 years)