Clinical trial NCT02096198: Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
Official title: 36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis
Post-Traumatic Osteoarthritis of Hip
Keywords: Total Hip Replacement
Total Hip Arthroplasty
Hip Joint Replacement
Hip Prosthesis Replacement
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from the original IDE study who have already been implanted with a Ceramax 36mm ceramic-on-ceramic system and who have given their consent for this study

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.

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.

Primary outcomes:
measure: Device survivorship at 10-years post-operatively
timeFrame: 10-years post-operatively
Secondary outcomes:
measure: Harris Hip scores
timeFrame: 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)
measure: Subject Hip Outcomes
timeFrame: 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)
measure: Radiographic
timeFrame: At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)
measure: Adverse Events
timeFrame: First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
measure: Device survivorship
timeFrame: 5-years, 6-years, 7-years, 8-years, and 9-years
Other outcomes:
Locations:
city: Sacramento
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
facility: Orthopedic One
state: Ohio
city: Alexandria
country: United States
state: Virginia
Study officials:
References: