Status:
ACTIVE_NOT_RECRUITING
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Joint Disease
Eligibility:
All Genders
21+ years
Brief Summary
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of stud...
Detailed Description
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the Nation...
Eligibility Criteria
Inclusion
- 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
- Subjects implanted with DYNASTY® BIOFOAM® Acetabular Shells
- Subjects implanted with a metal-on-metal articulation
- Subjects implanted with non-MicroPort Orthopedics components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
- Subjects skeletally immature (less than 21 years of age) at time of primary THA 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 :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02239783
Start Date
November 1 2014
End Date
November 1 2028
Last Update
November 18 2023
Active Locations (1)
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1
Ottawa Hospital
Ottawa, Ontario, Canada, K1H-8L6