Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement (COC36mmPAS)

January 28, 2019 updated by: DePuy Orthopaedics

36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects

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)

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States
    • Colorado
      • Denver, Colorado, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Orthopedic One
    • Virginia
      • Alexandria, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device survivorship at 10-years post-operatively
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip scores
Time Frame: 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)
The Harris Hip score consists of five sub-scales: Pain, Function, Activities Deformity and Range of motion. The instrument is designed for completion by a clinician.
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
Time Frame: 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)

Subject Hip Outcomes is a standardized instrument for use as a measure of health outcome that is designed for completion by the study subject. This hips outcomes self-assessment includes five (5) questions about subject satisfaction and hip function. The 5 questions relate to study subject function, pain, need for pain meds, satisfaction and their status (i.e., better, same or worse).

The percent of subjects who answer 'Yes' or 'Better' on each respective question will be reported.

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

At 5 to 7 years, at Minimum 8-years and at minimum 10-years, secondary radiographic outcome measures will include high quality antero-posterior and lateral radiographs of the operative hip, which will be obtained during the same postoperative follow-up intervals as for the clinical evaluations. At the first "enrollment" visit (5-7 years), an additional Cross-Table Lateral films will be collected to permit assessment of cup positioning.

Radiographic views will include:

  • AP Pelvis
  • AP femur
  • Lauenstein Lateral
  • Cross-Table Lateral (only at the first visit at 5-7 years)

As a single composite radiographic outcome, the percent of subjects with radiolucencies greater than 2 mm in any zone, acetabular cup migration greater than 4 mm, change in cup inclination greater than 4 degrees or osteolysis at the time of last radiographic assessment will be reported.

At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)
Adverse Events
Time Frame: First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Subjects who consent to participate in this trial have already had their index surgery for implantation of the study hip; however, potential adverse events may still occur and will be captured at each follow-up visit.
First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Device survivorship
Time Frame: 5-years, 6-years, 7-years, 8-years, and 9-years
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at years 5 through 9 post-operatively
5-years, 6-years, 7-years, 8-years, and 9-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

August 20, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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