DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study

DePuy Orthopaedics6 sites in 1 country106 target enrollmentJanuary 1, 2006

ConditionsNon-inflammatory Joint Disease Osteoarthritis Avascular Necrosis Congenital Hip Dysplasia Post-traumatic Arthritis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Non-inflammatory Joint Disease
Sponsor: DePuy Orthopaedics
Enrollment: 106
Locations: 6
Primary Endpoint: Survivorship
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.

Detailed Description

This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase. The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of: 1. a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and 2. a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.

Registry

clinicaltrials.gov

Start Date

January 1, 2006

End Date

April 1, 2014

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

DePuy Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Skeletally mature
•Provide informed consent
•Sufficient acetabular and femoral bone stock to seat the prosthesis
•Willing and able to return for follow-up as specified by the study protocol
•Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12)
•Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis.

Exclusion Criteria

•Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc.
•Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc.
•Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation.
•Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant.
•Morbid obesity
•Involvement in high levels of activity or participation in active sports
•Involvement in heavy manual labor employment
•Increased likelihood of falls due to concomitant illnesses or impairment
•Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser
•Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant

Outcomes

Primary Outcomes

Survivorship

Time Frame: 5 years

Secondary Outcomes

Study subject SF-12 health survey(1, 2 ,3, 4 and 5 years)
SF-12 Health survey and Subject Outcomes Questionnaire(6, 7, 8, 9 and 10 years)
Hip Function (using Harris Hip Score)(6 weeks, 6 months and 1, 2, 3, 4, and 5 years)