Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

This study has been completed.
Information provided by (Responsible Party):
DePuy Orthopaedics Identifier:
First received: March 23, 2006
Last updated: July 28, 2014
Last verified: July 2014
This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:

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: 1593
Study Start Date: July 2000
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00306930

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

Responsible Party: DePuy Orthopaedics Identifier: NCT00306930     History of Changes
Other Study ID Numbers: PIN 
Study First Received: March 23, 2006
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 22, 2016