CONSERVE Plus Post-Approval Study (PAS)

Other and Unspecified Injury to Hip and Thigh Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01367899
• Other study ID #: 09-LJH-002
• Status: Terminated
• Phase: N/A
• First received: May 2, 2011
• Last updated: October 24, 2014
• Start date: November 2010
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 199
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Other and Unspecified Injury to Hip and Thigh

Locations

Country	Name	City	State
United States	Michael Bolognesi, MD	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Radiographic outcomes	Secondary measures: radiographic outcomes	10 years	Yes
Secondary	Metal Ion (serum)	metal ion (serum) and renal function will also be collected.	24 months	Yes
Secondary	Assessment for Adverse Events	Subjects will be assessed for any adverse events during their length of participation	10 years	Yes
Secondary	Measurement of Patient Satisfaction	Patient satisfaction as assessed by the SF-12	10 years	No