CONSERVE Plus Post-Approval Study (PAS)

Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study

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.

Study Overview

• Status: Terminated
• Conditions: Other and Unspecified Injury to Hip and Thigh

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 Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Michael Bolognesi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have already undergone hip resurfacing in the CONSERVE Plus IDE.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CONSERVE® Plus hip resurfacing; Recipients/C Plus (IDE)study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success at Month 120	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.	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Michael Bolognesi, MD, Duke University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Efficacy
• Other Study ID Numbers: 09-LJH-002