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

Phase 4

Terminated

• Conditions: Avascular Necrosis; Osteoarthritis; Non-inflammatory Joint Disease; Post-traumatic Arthritis; Congenital Hip Dysplasia
• Interventions: Device: Total hip replacement/arthroplasty

• Registration Number: NCT00546598
• Lead Sponsor: DePuy Orthopaedics

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.

Study Timeline

• Study Start: 2006-01-01
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Primary Completion: 2014-04-01
• Study Completion: 2014-04-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 106

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duraloc Option COC Hip	Total hip replacement/arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Survivorship	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Memorial Hospital; 🇺🇸 Springfield, Illinois, United States

St. Luke's Hospital; 🇺🇸 Maumee, Ohio, United States

Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

St. John's Hospital; 🇺🇸 Springfield, Illinois, United States

Flower Hospital; 🇺🇸 Sylvania, Ohio, United States