28mm Ceramic-on-Ceramic Total Hip Replacement Study

Osteoarthritis Clinical Trial

— COC28  

Official title:

Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01657435
• Other study ID #: 09001
• Status: Terminated
• Start date: May 1, 2012
• Est. completion date: September 24, 2019

Study information

• Verified date: November 2019
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 185
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Joint Diseases
• Necrosis
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis
• Post-traumatic Arthritis

Intervention

Device:
• Ceramax Acetabular System
28mm Ceramic-on-ceramic Acetabular Cup System

Locations

Country	Name	City	State
Canada	McGill University - Jewish General Hospital	Montreal	Quebec
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Cardinal Orthopaedic Institute	Columbus	Ohio
United States	Colorado Joint Replacement	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Florida University	Gainesville	Florida
United States	UPenn	Philadelphia	Pennsylvania
United States	Joint Surgeons of Sacremento	Sacramento	California
United States	FOI Florida Orthopaedic Institute	Tampa	Florida
United States	OrthoCarolina	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence [NICE]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.	10 years
Secondary	Harris Hip Score	At five years, the Harris Hip Score must be > 80 points or higher and the Harris Hip pain assessment must be mild or no pain.	5 years
Secondary	Radiographic	At 5 years, secondary radiographic outcome measures will include: No radiolucencies >2mm in any zone in any post-operative interval; No acetabular cup migration >4mm; No change in cup inclination angle >4 degrees when compared to immediate post-operative angle; and; No osteolysis.	5 years
Secondary	Survivorship	At 5 years, the secondary outcome measure will include no components removed for any reason.	5 years