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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 November 2023 |
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Main ID: |
NCT02239783 |
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Date of registration:
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11/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems
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Scientific title:
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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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143 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02239783 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Paul Beaule, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Hospital Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 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
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Joint Disease
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Intervention(s)
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Device: total hip arthroplasty implant
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Primary Outcome(s)
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Component Survivorship
[Time Frame: 10 years post-operative]
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Secondary Outcome(s)
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Patient functional outcomes
[Time Frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years]
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Secondary ID(s)
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12-LJH-002I
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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