Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement - Full Text View

Sponsor:	DePuy Orthopaedics
Information provided by (Responsible Party):	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00306930

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 IV

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:

MedlinePlus related topics: Hip Replacement Osteoarthritis Osteonecrosis Rheumatoid Arthritis

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
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 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:

Jennifer Hoag, MS

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:	January 18, 2012
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 February 09, 2012