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Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00306930
First received: March 23, 2006
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Arthritis
Avascular Necrosis
Acute Fracture
 Device: Acetabular cup
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years. ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. ] [ Designated as safety issue: No ]
  • Short Form-36 (SF-36) [ Time Frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years. ] [ Designated as safety issue: No ]

Enrollment: 1500
Study Start Date: October 2000
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
Acetabular cup replacement with total hip arthroplasty
 Device: Acetabular cup
Acetabular cup replacement
Other Name: Pinnacle™ Cup

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hip replacement
  • Sufficient bone stock to support implant

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00306930     History of Changes
Other Study ID Numbers: PIN
Study First Received: March 23, 2006
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013