CONSERVE Plus Post-Approval Study (PAS)

Stopped early

Conditions studied: Other and Unspecified Injury to Hip and Thigh

In brief

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.

Key facts

Study ID

NCT01367899

Run by

MicroPort Orthopedics Inc.

People needed

199

Starts

2010-11-01

Expected to finish

2014-09-01

Last updated by the study team

2014-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient is mentally incompetent.
• Patient is a prisoner.
• Patient is an alcohol and/or drug abuser
• Patient has undergone device revision or removal

Where it is running

• Michael Bolognesi, MD — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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