CONSERVE Plus Post-Approval Study (PAS)
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | November 2010 |
| End Date: | November 2015 |
| Contact: | Heather Robertson |
| Email: | Heather.Robertson@wmt.com |
| Phone: | 818-470-3332 |
Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
The objective of this post-approval study is to provide scientifically valid and reliable
evidence that supports claims of longer term safety and effectiveness with regard to Month
120 device survivorship rates.
evidence that supports claims of longer term safety and effectiveness with regard to Month
120 device survivorship rates.
This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under
actual conditions of use. Additionally, this study will evaluate the performance of the
device in the post approval environment to see if there are any significant changes in
device performance as compared to the pre-market IDE Study
actual conditions of use. Additionally, this study will evaluate the performance of the
device in the post approval environment to see if there are any significant changes in
device performance as compared to the pre-market IDE Study
Inclusion Criteria:
1. Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited
Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
2. Is willing and able to comply with the study plan and able to understand and sign the
Patient Informed Consent Form.
Exclusion Criteria:
1. Patient is mentally incompetent.
2. Patient is a prisoner.
3. Patient is an alcohol and/or drug abuser
4. Patient has undergone device revision or removal
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