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Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT00306930
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Arthritis Avascular Necrosis Acute Fracture Device: Acetabular cup Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1593 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty
Study Start Date : July 2000
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
A
Acetabular cup replacement with total hip arthroplasty
Device: Acetabular cup
Acetabular cup replacement
Other Name: Pinnacle™ Cup



Primary Outcome Measures :
  1. Survivorship [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years. ]
  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. ]
  3. Short Form-36 (SF-36) [ Time Frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00306930


Locations
United States, Indiana
DePuy Orthopaedics
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00306930     History of Changes
Other Study ID Numbers: PIN
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by DePuy Orthopaedics:
Total Hip Replacement
post-traumatic arthritis

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