Clinical trial NCT01657435: 28mm Ceramic-on-Ceramic Total Hip Replacement Study
Official title: Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis
Post-traumatic Arthritis
Keywords: Total hip replacement
Total hip arthroplasty
Hip joint replacement
Hip prosthesis replacement
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 185
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females who are appropriate candidates for primary hip replacement o any age, with non-inflammatory degenerative joint disease or: males and females that had a primary hip replacement with CERAMAX as part of the 28 mm IDE study.

Brief summary: This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.

In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.

In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.

Detailed description: This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:

1. a clinical follow-up phase and
2. a clinical outcomes phase.

Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.

Eligibility criteria: Inclusion Criteria:

* Subjects who were previously enrolled in the COC28 IDE study, or
* Newly recruited individuals who are qualified based on the approved labeling of the device, and;
* 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 Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol

Exclusion Criteria:

* In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.

Primary outcomes:
measure: Survivorship
timeFrame: 10 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 5 years
measure: Radiographic
timeFrame: 5 years
measure: Survivorship
timeFrame: 5 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Joint Surgeons of Sacremento
state: California
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Gainesville
country: United States
facility: Florida University
state: Florida
city: Tampa
country: United States
facility: FOI Florida Orthopaedic Institute
state: Florida
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: OrthoCarolina
state: North Carolina
city: Columbus
country: United States
facility: Cardinal Orthopaedic Institute
state: Ohio
city: Philadelphia
country: United States
facility: UPenn
state: Pennsylvania
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
city: Montreal
country: Canada
facility: McGill University - Jewish General Hospital
state: Quebec
Study officials:
affiliation: DePuy Orthopaedics
name: Tammy L ODell, BS CCRC CCRA
role: STUDY_DIRECTOR
References: