Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

NCT ID: NCT00588861

Last Updated: 2017-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.

Detailed Description

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The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.

Conditions

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Osteoarthritis, Hip Traumatic Arthritis of Hip

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Answer® hip stem with Simplex Cement

Femoral stem replacement with Answer® hip stem \& Simplex Bone Cement

Group Type ACTIVE_COMPARATOR

Answer® hip stem

Intervention Type DEVICE

Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Answer® hip stem

Intervention Type DEVICE

Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Answer® hip stem with Palacos Cement

Femoral stem replacement with Answer® hip stem \& Palacos Bone Cement

Group Type ACTIVE_COMPARATOR

Answer® hip stem

Intervention Type DEVICE

Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Answer® hip stem

Intervention Type DEVICE

Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Interventions

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Answer® hip stem

Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Intervention Type DEVICE

Answer® hip stem

Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.

Intervention Type DEVICE

Other Intervention Names

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Answer Hip Stem Simplex Bone Cement Answer Hip Stem Palacos Bone Cement

Eligibility Criteria

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Inclusion Criteria

* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Exclusion Criteria

* Infection, sepsis, and osteomyelitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ken Beres, MD

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Biomet Orthopedics, LLC

Warsaw, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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101-U-011

Identifier Type: -

Identifier Source: org_study_id

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