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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306917
Recruitment Status : Terminated (Terminated due to limited enrollment and follow up.)
First Posted : March 27, 2006
Results First Posted : March 10, 2010
Last Update Posted : December 5, 2011
Information provided by (Responsible Party):
DePuy Orthopaedics

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Avascular Necrosis Acute Fracture Device: non-coated femoral hip stem Device: coated femoral hip stem Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty
Study Start Date : November 2002
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
DuoFix HA
Device: non-coated femoral hip stem
total hip replacement
Other Name: Summit DuoFix HA hip stem
Active Comparator: 2
Porocoat porous coated
Device: coated femoral hip stem
total hip replacement
Other Name: Summit Porocoated porous coated hip stem.

Primary Outcome Measures :
  1. Harris Hip Score (HHS) [ Time Frame: Preoperative, 6, 12, 24, 36, 48, and 60 months ]
    The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.

Secondary Outcome Measures :
  1. Medical Imaging [ Time Frame: postoperative, 6, 12, 24, 36, 48 and 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306917

United States, Indiana
DePuy Orthopaedics
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
DePuy Orthopaedics
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

Responsible Party: DePuy Orthopaedics Identifier: NCT00306917     History of Changes
Other Study ID Numbers: SPD
First Posted: March 27, 2006    Key Record Dates
Results First Posted: March 10, 2010
Last Update Posted: December 5, 2011
Last Verified: December 2011

Keywords provided by DePuy Orthopaedics:
Total Hip Replacement

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes