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

This study has been terminated.

( Terminated due to limited enrollment and follow up. )

First Received: March 23, 2006 Last Updated: June 3, 2009 History of Changes

Sponsored by:	DePuy Orthopaedics
Information provided by:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00306917

Purpose

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

Condition	Intervention	Phase
Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Avascular Necrosis Acute Fracture	Device: non-coated femoral hip stem Device: coated femoral hip stem	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:

Harris Hip score [ Time Frame: pre-operative, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medical imaging [ Time Frame: postoperative, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]

Enrollment:	400
Study Start Date:	November 2002
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator DuoFix HA	Device: non-coated femoral hip stem total hip replacement
2: Active Comparator Porocoat porous coated	Device: coated femoral hip stem total hip replacement

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306917

Locations

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

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

Principal Investigator:	David A Fisher, MD	Orthopaedics Indianapolis
Principal Investigator:	J W Mesko, MD	Michigan Orthopaedics Center
Principal Investigator:	Paul Perona, MD	St Margaret's Hospital Family Orthopaedics
Principal Investigator:	Stephan B Lowe, MD	Orthopaedic Specialists of the Carolinas
Principal Investigator:	Donald L Pomeroy, MD	Pomeroy & Reddy
Principal Investigator:	Nithin Reddy, MD	Pomeroy & Reddy

More Information

No publications provided

Responsible Party:	DePuy Orthopaedics, Inc. ( Barry Sisson, MBA )
Study ID Numbers:	SPD
Study First Received:	March 23, 2006
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00306917 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:

Total Hip Replacement

Study placed in the following topic categories:

Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Fractures, Bone
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 11, 2009