CONSERVE Plus Post-Approval Study (PAS)

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01367899

Enrollment

199

Registered

2011-06-07

Start date

2010-11-30

Completion date

2014-09-30

Last updated

2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other and Unspecified Injury to Hip and Thigh

Keywords

Safety, Efficacy

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results