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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00546598
• Other study ID #: 05024
• Status: Terminated
• Phase: Phase 4
• Start date: January 1, 2006
• Est. completion date: April 1, 2014

Study information

• Verified date: November 2021
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: April 1, 2014
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Avascular Necrosis
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Joint Diseases
• Necrosis
• Non-inflammatory Joint Disease
• Osteoarthritis
• Post-traumatic Arthritis

Intervention

Device:
• Total hip replacement/arthroplasty
Hip replacement

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia
United States	Fairview Hospital	Cleveland	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Memorial Hospital	Springfield	Illinois
United States	St. John's Hospital	Springfield	Illinois
United States	Flower Hospital	Sylvania	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship		5 years
Secondary	Study subject SF-12 health survey		1, 2 ,3, 4 and 5 years
Secondary	SF-12 Health survey and Subject Outcomes Questionnaire		6, 7, 8, 9 and 10 years
Secondary	Hip Function (using Harris Hip Score)		6 weeks, 6 months and 1, 2, 3, 4, and 5 years