CONSERVE Plus Post-Approval Study (PAS)

Terminated

• Conditions: Other and Unspecified Injury to Hip and Thigh

• Registration Number: NCT01367899
• Lead Sponsor: MicroPort Orthopedics Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-24
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success at Month 120	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic outcomes	10 years	Secondary measures: radiographic outcomes
Metal Ion (serum)	24 months	metal ion (serum) and renal function will also be collected.
Measurement of Patient Satisfaction	10 years	Patient satisfaction as assessed by the SF-12
Assessment for Adverse Events	10 years	Subjects will be assessed for any adverse events during their length of participation

Trial Locations

Locations (1)

Michael Bolognesi, MD; 🇺🇸 Durham, North Carolina, United States