Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

July 28, 2014 updated by: DePuy Orthopaedics

Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Study Type

Interventional

Enrollment (Actual)

1593

Phase

  • Not Applicable

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
    • Indiana
      • Warsaw, Indiana, United States, 46581
        • DePuy Orthopaedics

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary hip replacement
  • Sufficient bone stock to support implant
  • Signed Informed Patient Consent form

Exclusion Criteria:

  • Prior renal transplant
  • History of active joint sepsis
  • Recent high dose of corticosteroids
  • Primary or secondary carcinoma in the last 5 years
  • Neurological disease
  • Psychosocial disease that would limit rehabilitation
  • Use of structural bone graft
  • Simultaneous participation in another hip study

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
Acetabular cup replacement with total hip arthroplasty
Device: Acetabular cup
Acetabular cup replacement
Other Names:
  • Pinnacle™ Cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survivorship
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score
Time Frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.
Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Short Form-36 (SF-36)
Time Frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

Collaborators and Investigators

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

Sponsor

DePuy Orthopaedics

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

July 1, 2000

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (Estimate)

March 27, 2006

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIN

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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