Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-inflammatory Joint Disease Osteoarthritis Avascular Necrosis Congenital Hip Dysplasia Post-traumatic Arthritis	Device: Total hip replacement/arthroplasty Device: Hip replacement/arthroplasty	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Hip Replacement Joint Disorders Osteoarthritis

U.S. FDA Resources

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:

Hip function (using Harris Hip Score) [ Time Frame: 6 weeks, 6 months and 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Study subject SF-12 health survey [ Time Frame: 1, 2 ,3, 4 and 5 years ] [ Designated as safety issue: No ]
SF-12 Health survey and Subject Outcomes Questionnaire [ Time Frame: 6, 7, 8, 9 and 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	January 2006
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Duraloc Option COC Hip	Device: Total hip replacement/arthroplasty Hip replacement Other Name: DURALOC® Option Ceramic-on-Ceramic Hip system Device: Hip replacement/arthroplasty Hip replacement Other Name: DURALOC® Option Ceramic-on-Ceramic Hip 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:

a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and
a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease)
Known presence of active metastatic or neoplastic disease
Known allergic reactions to implant materials (e.g. ceramic, metal)
Known history of tissue reactions to implant corrosion or implant wear debris
Disabilities of other joints that impedes evaluation (e.g. knees, ankles)
Known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.)
Previous prosthetic hip replacement device (any type including THA, surface replacement arthroplasty, endoprosthesis etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546598

Locations

United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Memorial Hospital
Springfield, Illinois, United States, 62781
St. John's Hospital
Springfield, Illinois, United States, 62781
United States, Ohio
Fairview Hospital
Cleveland, Ohio, United States, 44111
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Flower Hospital
Sylvania, Ohio, United States, 43560

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

Study Director:

Dave Whalen, BS, DC

DePuy Orthopaedics

More Information

No publications provided

Responsible Party:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00546598 History of Changes
Other Study ID Numbers:	05024
Study First Received:	October 17, 2007
Last Updated:	June 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:

Total hip replacement, Total hip arthroplasty

Additional relevant MeSH terms:

Arthritis
Hip Dislocation, Congenital
Joint Diseases
Necrosis
Osteonecrosis
Osteoarthritis

Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013