36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-inflammatory Degenerative Joint Disease
- Sponsor
- DePuy Orthopaedics
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Device survivorship at 10-years post-operatively
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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)
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Device survivorship at 10-years post-operatively
Time Frame: 10-years post-operatively
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10-years post-operatively.
Secondary Outcomes
- Harris Hip scores(Harris Hip score means and Harris Hip sub-score means will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days))
- Subject Hip Outcomes(Subject Hip Outcomes will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days))
- Device survivorship(5-years, 6-years, 7-years, 8-years, and 9-years)
- Radiographic(At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days))
- Adverse Events(First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days))