N/A
Completed N=464
ABC/Trident® Ceramic Post Approval Study
Arthroplasty, Replacement, Hip
Source: ClinicalTrials.gov NCT00960206 ↗
Enrolled (actual)
464
Serious AEs
0.5%
Results posted
Aug 2014
Primary outcomePrimary: Component Revision and Complications — 2; 2; 2 hips — p=0.0832
Summary
The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Component Revision and Complications |
2; 2; 2 | 0.0832 |
| SECONDARY Harris Hip Score |
160; 171; 81; 2; 2; 2 | 0.3701 |
| SECONDARY Radiographic Evaluation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Hip Follow-Up Questionnaire |
163; 146; 76; 142; 129; 63 | 0.6011 |
Eligibility Criteria
Inclusion Criteria
- The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).
- The individual is between the ages of 21 and 75 years.
- The individual is not classified as morbidly obese.
- The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.
- The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).
- The individual does not have an active infection within the affected hip joint.
- The individual has not had a previous total hip replacement or hip fusion to the affected hip joint.
- The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse).
- The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device.
- The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements.
- The individual is skeletally mature.
- The individual is not pregnant.
- The individual is not a prisoner.
- The individual has no plans to relocate to another geographic area before the completion of the study.
Data sourced from ClinicalTrials.gov (NCT00960206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.