Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

NCT ID: NCT00306930

Last Updated: 2014-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Osteoarthritis Rheumatoid Arthritis Arthritis Avascular Necrosis Acute Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Acetabular cup replacement with total hip arthroplasty

Group Type OTHER

Acetabular cup

Intervention Type DEVICE

Acetabular cup replacement

Interventions

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Acetabular cup

Acetabular cup replacement

Intervention Type DEVICE

Other Intervention Names

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Pinnacle™ Cup

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dave Whalen, BS, DC

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

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DePuy Orthopaedics

Warsaw, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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PIN

Identifier Type: -

Identifier Source: org_study_id

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