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

DePuy Synthes

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis; Congenital Hip Dysplasia; Avascular Necrosis; Post-traumatic Arthritis; Non-inflammatory Joint Disease

Treatments: Device: Total hip replacement/arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546598

05024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Duraloc Option COC Hip

Other group

Treatment:

Device: Total hip replacement/arthroplasty