Status:
ACTIVE_NOT_RECRUITING
Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Joint Disease
Eligibility:
All Genders
21+ years
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 regulator...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02285842
Start Date
December 1 2014
End Date
December 1 2028
Last Update
June 7 2023
Active Locations (1)
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1
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6