CONSERVE Plus Post-Approval Study (PAS)

MicroPort

Status: Terminated

Conditions: Other and Unspecified Injury to Hip and Thigh

Study type: Observational

Funder types: Industry

Identifiers

NCT01367899

09-LJH-002

Details and patient eligibility

About

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.

Full 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

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

199 participants in 1 patient group

CONSERVE® Plus hip resurfacing

Description:

Recipients/C Plus (IDE)study