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

NCT02096198 | Completed

• 1 other identifier: 11013
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 5

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)

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

Outcome Measures

Primary Outcomes (1)

• Device survivorship at 10-years post-operatively

  Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10-years post-operatively.

  10-years post-operatively

Secondary Outcomes (5)

• Harris Hip scores

  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)

• Subject Hip Outcomes

  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)

• Radiographic

  At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)

• Adverse Events

  First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)

• Device survivorship

  5-years, 6-years, 7-years, 8-years, and 9-years

Study Arms (1)

Other CERAMAX COC 36mm Acetabular Cup

The CERAMAX COC 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (5)

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Orthopedic One

Columbus, Ohio, 43213, United States

Location

Unknown Facility

Alexandria, Virginia, United States

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 Design

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

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: January 1, 2014
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (5)