Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement

NCT ID: NCT00306917

Last Updated: 2022-07-19

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

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-01

Study Completion Date

2009-01-29

Brief Summary

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Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Detailed Description

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Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.

Conditions

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Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Avascular Necrosis Acute Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

DuoFix HA

Group Type ACTIVE_COMPARATOR

non-coated femoral hip stem

Intervention Type DEVICE

total hip replacement

2

Porocoat porous coated

Group Type ACTIVE_COMPARATOR

coated femoral hip stem

Intervention Type DEVICE

total hip replacement

Interventions

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non-coated femoral hip stem

total hip replacement

Intervention Type DEVICE

coated femoral hip stem

total hip replacement

Intervention Type DEVICE

Other Intervention Names

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Summit DuoFix HA hip stem Summit Porocoated porous coated hip stem.

Eligibility Criteria

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Inclusion Criteria

* Primary total hip replacement
* Patient age less than or equal to 75
* Sufficient bone stock to support prosthesis

Exclusion Criteria

* Previous hip replacement
* Significant angular/bony deformity
* Active joint sepsis
* Metal allergy
* Renal transplant
* Psychosocial disease
* Neurological disease/musculoskeletal disease that may affect weight-bearing
Maximum Eligible Age

75 Years

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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David A Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedics Indianapolis

J W Mesko, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Orthopaedics Center

Paul Perona, MD

Role: PRINCIPAL_INVESTIGATOR

St Margaret's Hospital Family Orthopaedics

Stephan B Lowe, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Specialists of the Carolinas

Donald L Pomeroy, MD

Role: PRINCIPAL_INVESTIGATOR

Pomeroy & Reddy

Nithin Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Pomeroy & Reddy

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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SPD

Identifier Type: -

Identifier Source: org_study_id

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