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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Duraloc Option COC Hip	Device: Total hip replacement/arthroplasty; Hip replacement; Other Names: DURALOC® Option Ceramic-on-Ceramic Hip system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survivorship	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2006
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 18, 2007
• First Posted (ESTIMATE): October 19, 2007

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Total hip replacement, Total hip arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Joint Diseases; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 05024