CONSERVE Plus Post-Approval Study (PAS)
This study is currently recruiting participants.
Verified July 2012 by Wright Medical Technology
Information provided by (Responsible Party):
Wright Medical Technology
First received: May 2, 2011
Last updated: August 23, 2012
Last verified: July 2012
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.
Other and Unspecified Injury to Hip and Thigh
||Observational Model: Cohort
Time Perspective: Prospective
||Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
Primary Outcome Measures:
Secondary Outcome Measures:
- Radiographic outcomes [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Secondary measures: radiographic outcomes
- Metal Ion (serum) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
metal ion (serum) and renal function will also be collected.
- Assessment for Adverse Events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Subjects will be assessed for any adverse events during their length of participation
- Measurement of Patient Satisfaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Patient satisfaction as assessed by the SF-12
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2015 (Final data collection date for primary outcome measure)
CONSERVE® Plus hip resurfacing
Recipients/C Plus (IDE)study
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients who have already undergone hip resurfacing in the CONSERVE Plus IDE.
- 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".
- Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
- Patient is mentally incompetent.
- Patient is a prisoner.
- Patient is an alcohol and/or drug abuser
- Patient has undergone device revision or removal
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367899
|Michael Bolognesi, MD
|Durham, North Carolina, United States, 27705 |
|Contact: Suzanne Finley 919-684-3193 email@example.com |
|Principal Investigator: Michael Bolognesi, MD |
Wright Medical Technology
||Michael Bolognesi, MD
No publications provided
||Wright Medical Technology
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2011
||August 23, 2012
||United States: Institutional Review Board
Keywords provided by Wright Medical Technology:
ClinicalTrials.gov processed this record on May 21, 2013