Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic, Orthopedic |
Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 20 - 75 |
Updated: | 1/31/2019 |
Start Date: | January 1, 2014 |
End Date: | August 20, 2018 |
36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to
10-years) information regarding the performance and safety of the commercially available 36mm
CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were
previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component
that articulates with a ceramic femoral head in the COC total hip replacement system)
10-years) information regarding the performance and safety of the commercially available 36mm
CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were
previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component
that articulates with a ceramic femoral head in the COC total hip replacement system)
Up to five (5) sites will participate. These sites participated in the IDE study and will
continue subject follow-up.
Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen
for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op
or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years
(3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and
adverse event information will be collected at each visit.
If a subject is not willing or able to return for a clinical and radiographic follow-up for
either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone
interview may be utilized for the purpose of determining device survivorship.
continue subject follow-up.
Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen
for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op
or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years
(3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and
adverse event information will be collected at each visit.
If a subject is not willing or able to return for a clinical and radiographic follow-up for
either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone
interview may be utilized for the purpose of determining device survivorship.
Inclusion Criteria:
- Subjects who were previously enrolled in the COC 36 IDE study;
- Individuals who are willing and able to provide informed patient consent for
participation in the study;
- Individuals who are willing and able to return for follow-up as specified by the study
protocol; and
- Individuals who are willing and able to complete the Subject Hip Outcomes
questionnaire as specified by the study protocol.
Exclusion Criteria:
- In the opinion of the Investigator, the individual does not qualify if there are any
concerns with the ability to follow the protocol specified evaluations.
- Any component of the primary total hip was previously revised.
We found this trial at
5
sites
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