Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

Rheumatoid Arthritis Clinical Trial

Official title:

Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306930
• Other study ID #: PIN
• Status: Completed
• Phase: N/A
• First received: March 23, 2006
• Last updated: July 28, 2014
• Start date: July 2000
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1593
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Fracture
• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Acetabular cup
Acetabular cup replacement

Locations

Country	Name	City	State
United States	DePuy Orthopaedics	Warsaw	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship		5 years	Yes
Secondary	Harris Hip Score		Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)		Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.	No
Secondary	Short Form-36 (SF-36)		Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.	No