Trials / Completed

CompletedNCT02096198

Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement

36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects

Status: Completed
Phase: —
Study type: Observational
Enrollment: 81 (actual)

Sponsor: DePuy Orthopaedics · Industry
Sex: All
Age: 20 Years – 75 Years
Healthy volunteers: Not accepted

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.

Conditions

Timeline

Start date: 2014-01-01
Primary completion: 2018-08-20
Completion: 2018-08-20
First posted: 2014-03-26
Last updated: 2019-01-29

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02096198. Inclusion in this directory is not an endorsement.