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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000013 / PAS001 |
| Date Original Protocol Accepted |
08/16/2003
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| Date Current Protocol Accepted |
08/16/2003
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| Study Name |
Osteonics Long Term
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| Device Name |
TRIDENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study is a 10-year, multi-center cohort study with three arms. The first arm is comprised of persons who received the ABC Systems I, II total hip replacement. The second arm is the control arm of patients who received the ABC III total hip replacement. The third and final arm is comprised of patients who received the Trident hip replacement. Study success required a Harris Hip Score >70, the absence of device revision or removal and radiographic success. The primary objective of the study is to continue following subjects who were in the Osteonic ABC System premarket clinical trial and the premarket study of the Trident System to evaluate the ongoing safety and effectiveness of the ABC and Trident hip implants through the 5th postoperative year, and the ongoing status of the hip using a questionnaire annually from 6 to 10 years postoperatively. Implanted hips could be unilateral or bilateral and could have an ABC hip on one side and a Trident hip on the other. Radiographic success was defined as the absence of:- progressive radiolucent lines > 2mm in thickness around the entire acetabular, -component, - migration of > 3mm of the acetabular component, - progressive radiolucent lines around the entire femoral component,- progressive subsidence of the femoral component > 5mm
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| Study Population |
Study population is as per device indication. These devices are indicated for patients requiring primary total hip arthroplasty due to painful disabling joint disease of the hip resulting from non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant).
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| Sample Size |
A total of 518 cases [310 ABC Study cases (214 ceramic/96 control), 208 Trident cases] were active in the PAS cohort as of March 12, 2003. Since then, a total of 54 cases have either declined to participate, died, or are been lost-to-follow-up. This PAS report contains data on 274 (185 ceramic/ 89 control) ABC Study cases and 190 Trident cases
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| Key Study Endpoints |
Harris Hip Score >70, the absence of device revision or removal and radiographic success; and radiographic success was defined as the absence of:- progressive radiolucent lines > 2mm in thickness around the entire acetabular component, - migration of > 3mm of the acetabular component, - progressive radiolucent lines around the entire femoral component, - progressive subsidence of the femoral component >5 mm
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| Follow-up Visits and Length of Follow-up |
Follow-ups will be conducted to determine ongoing status of the ABC and Trident hip implants through the 5th postoperative year, and the ongoing status of the hip using a questionnaire annually from 6 to 10 years .
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Fully 430 patients were enrolled.
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| Actual Number of Sites Enrolled |
A total of six study sites enrolled patients
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| Patient Follow-up Rate |
Ranged from 80.2% to 88.4% at 10 post-operative years for cases with any follow-up data reviewed or evaluated by an investigator except for those cases who have follow up data for that interval, but either died or were a failure after the data was collected, but prior to completion of the interval being reported.
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| Final Safety Findings |
No significant differences in reported patient satisfaction were observed between the Osteonics ABC, Trident, and control groups.
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| Final Effect Findings |
No statistically significant difference was noted between the proportion of Osteonics ABC patients and control patients with Harris Hip Scores > 80. No statistically significant difference was noted between the proportion of Trident patients and control patients with Harris Hip Scores > 80. A Harris Hip Score > 80 is considered to be a good result.
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| Study Strengths & Weaknesses |
Major strengths of the study include its 10 year duration to examine longer-term device performance and the inclusion of a control group to enhance its scientific rigor.
Study weaknesses include the absence of required clinical and radiographic examination during the last 5 years of patient follow-up.
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| Recommendations for Labeling Changes |
Labeling Change Recommended
Yes.
No statistically significant postoperative difference was noted between the proportion of Osteonics ABC patients and control patients with Harris Hip Scores > 80. No statistically significant difference was noted between the proportion of Trident patients and control patients with Harris Hip Scores > 80. A Harris Hip Score > 80 is considered to be a good result.
No significant differences in reported patient satisfaction were observed among the Osteonics ABC, Trident, and control groups.
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