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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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12 December 2020 |
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Main ID: |
NCT02507258 |
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Date of registration:
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21/07/2015 |
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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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PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
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Scientific title:
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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components |
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Date of first enrolment:
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December 2017 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02507258 |
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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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France
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Contacts
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Name:
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Gérard Giordano, 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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Hopital Joseph Ducuing |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Subject 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 skeletally immature (less than 21 years of age) at time of primary THA
surgery
- Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular
liners) in the enrolled THA
- 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 having 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: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell
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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 (hip specific)
[Time Frame: Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval]
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Secondary ID(s)
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12-LJH-002K
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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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