Clinical trial NCT00546598: Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System
Official title: DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Non-inflammatory Joint Disease
Osteoarthritis
Avascular Necrosis
Congenital Hip Dysplasia
Post-traumatic Arthritis
Keywords: Total hip replacement, Total hip arthroplasty
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.)

Primary outcomes:
measure: Survivorship
timeFrame: 5 years
Secondary outcomes:
measure: Study subject SF-12 health survey
timeFrame: 1, 2 ,3, 4 and 5 years
measure: SF-12 Health survey and Subject Outcomes Questionnaire
timeFrame: 6, 7, 8, 9 and 10 years
measure: Hip Function (using Harris Hip Score)
timeFrame: 6 weeks, 6 months and 1, 2, 3, 4, and 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Springfield
country: United States
facility: Memorial Hospital
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Maumee
country: United States
facility: St. Luke's Hospital
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital
state: Ohio
Study officials:
affiliation: DePuy Orthopaedics
name: Dave Whalen, BS, DC
role: STUDY_DIRECTOR
References: