28mm Ceramic-on-Ceramic Total Hip Replacement Study

NCT01657435 | Terminated

• 1 other identifier: 09001
• Study Type: observational
• Target: 185
• Locations: 2 countries
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Harris Hip Score

  5 years

• Radiographic

  5 years

• Survivorship

  5 years

Study Arms (1)

Ceramax COC 28mm Acetabular Cup

The 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper.

Device: Ceramax Acetabular System

Interventions

Ceramax Acetabular System DEVICE

28mm Ceramic-on-ceramic Acetabular Cup System

Also known as: Ceramic-on-ceramic 28 mm Acetabular Cup

Ceramax COC 28mm Acetabular Cup

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (13)

Joint Surgeons of Sacremento

Sacramento, California, United States

Location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Unknown Facility

Fort Collins, Colorado, United States

Location

Florida University

Gainesville, Florida, United States

Location

FOI Florida Orthopaedic Institute

Tampa, Florida, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, United States

Location

Duke University

Durham, North Carolina, United States

Location

OrthoCarolina

Winston-Salem, North Carolina, United States

Location

Cardinal Orthopaedic Institute

Columbus, Ohio, United States

Location

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Location

McGill University - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tammy L ODell, BS CCRC CCRA

  DePuy Orthopaedics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: May 1, 2012
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

US (12); CA (1)