CONSERVE Plus Post-Approval Study (PAS)
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study|
- Clinical success at Month 120 [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least "good" function/pain relief defined as Harris Hip Score ≥ 80.
- 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
|Study Start Date:||November 2010|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367899
|United States, North Carolina|
|Michael Bolognesi, MD|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Michael Bolognesi, MD||Duke University|