Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System (NCT00546598) | Clinical Trial Compass
TerminatedPhase 4
Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System
Stopped: Sponsor withdrew PMA
United States106 participantsStarted 2006-01-01
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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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…