Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

DePuy Synthes

Status: Completed

Conditions: Osteoarthritis; Arthritis; Acute Fracture; Avascular Necrosis; Rheumatoid Arthritis

Treatments: Device: Acetabular cup

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306930

PIN

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,593 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,593 participants in 1 patient group

A

Other group

Description:

Acetabular cup replacement with total hip arthroplasty

Treatment:

Device: Acetabular cup