|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS110093 / PSS001 |
| Date Original Plan Accepted |
12/07/2012
|
| Date Current Plan Accepted |
09/21/2015
|
| Study Name |
Cross-Sectional Study
|
| Device Name |
Zweymueller-sl hip prosthesis stem
|
| Root Document Number |
K871453
K032348
K033634
K033943
K974728
K003758
K053536
K071723
K091003
K091973
K063251
K071856
K073499
K081007
|
| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Cross-sectional study design, new enrollment
|
| Sample Size |
The sample size is expected to be comprised of 400 males and females who underwent metal on metal THR within the
last 96 months (range 1-8 years. For baseline measurement of pre-implant whole blood and serum cobalt and chromium ion levels 120 males and females who do not currently have a medical device implant will be enrolled.
|
| Key Study Endpoints |
Study endpoints include adverse events, changes in metal ion concentrations in whole blood and serum over time, radiographic results and any incidence of adverse local tissue reactions that might be linked to metal ion levels or certain patient clinical or demographic characteristics
|
| Follow-up Visits and Length of Follow-up |
Patients will undergo a one-time cross-sectional assessment, as available by product release date.
|
| Interim or Final Data Summary |
| Interim Results |
Pre-operative Demographics:
1. The preoperative diagnoses of the study participants are supportive of the representativeness of the study population as the leading diagnosis was osteoarthritis with avascular necrosis a distant second. This is highly consistent with the experience of the general population in terms of preoperative diagnoses.
2. The reported mean height, weight, and age of study hip implant patients is consistent with the mean height, weight and age of the general population of hip implant patients.
Effectiveness Findings:
1. A “good” Harris Hip Score did not necessarily guarantee the absence of ALTR as the mean Harris Hip Score for patients with abnormal MRIs was 83.4 and the median Harris Hip Score for this group was 89.0.
|
| Actual Number of Patients Enrolled |
91 hips have been enrolled into the implant group. Non-hip implant
control patients total 163 patients. There was 1 patient enrolled who had undergone hip implant revision.
|
| Actual Number of Sites Enrolled |
4
|
| Patient Followup Rate |
Not applicable as the study design is cross-sectional
|
| Final Effectiveness Findings |
A “good” Harris Hip Score did not necessarily guarantee the absence of ALTR as the mean Harris Hip Score for patients with abnormal MRIs was 83.4 and the median Harris Hip Score for this group was 89.0.
|
