A Clinical Investigation of the C2a-Taper™ Acetabular System

June 19, 2017 updated by: Biomet Orthopedics, LLC

Post Approval Study of the C2a-Taper™ Acetabular System

The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design:

Phase 1

Sites will collect the following types of data:

Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events

Follow-up Visit schedule

  • 6 week ± 2 weeks
  • 6 month ± 1 month
  • 1 year ± 3 months
  • 2 years ± 3 months
  • 3 years ± 3 months
  • 4 years ± 3 months
  • 5 years ± 3 months

Phase 2:

Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.

Study Type

Observational

Enrollment (Actual)

28

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

  • United States
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • Physician's Clinic of Iowa, PCI
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Lexington Clinic

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.

Description

Inclusion Criteria:

  • Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

Exclusion Criteria:

  • Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease

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
Intervention / Treatment
C2a Taper recipients
Patients who receive a THA with the C2a - Taper™ Acetabular System
Device: C2a - Taper™ Acetabular System
The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score, Radiographic Evaluation
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survivorship
Time Frame: 10 years
10 years

Collaborators and Investigators

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

Sponsor

Biomet Orthopedics, LLC

Investigators

  • Study Director: Kara Mezger, Zimmer Biomet

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

April 1, 2006

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 21, 2007

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.H021
  • P050009 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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