CONSERVE Plus Post-Approval Study (PAS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Other and Unspecified Injury to Hip and Thigh

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CONSERVE® Plus hip resurfacing

Recipients/C Plus (IDE)study

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No