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CONSERVE Plus Post-Approval Study (PAS)

This study is currently recruiting participants.
Verified July 2012 by Wright Medical Technology
Sponsor:
Information provided by (Responsible Party):
Wright Medical Technology
ClinicalTrials.gov Identifier:
NCT01367899
First received: May 2, 2011
Last updated: August 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Other and Unspecified Injury to Hip and Thigh

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study

Further study details as provided by Wright Medical Technology:

Primary Outcome Measures:
  • Clinical success at Month 120 [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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:
  • Radiographic outcomes [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Secondary measures: radiographic outcomes

  • Metal Ion (serum) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    metal ion (serum) and renal function will also be collected.

  • Assessment for Adverse Events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Subjects will be assessed for any adverse events during their length of participation

  • Measurement of Patient Satisfaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Patient satisfaction as assessed by the SF-12


Estimated Enrollment: 353
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
CONSERVE® Plus hip resurfacing
Recipients/C Plus (IDE)study

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367899

Contacts
Contact: Heather Robertson 818-470-3332 Heather.Robertson@wmt.com
Contact: Cherita B Walton, BS, CCRP 901-867-4508 cwalton@wmt.com

Locations
United States, North Carolina
Michael Bolognesi, MD Recruiting
Durham, North Carolina, United States, 27705
Contact: Suzanne Finley     919-684-3193     suzanne.finley@duke.edu    
Principal Investigator: Michael Bolognesi, MD            
Sponsors and Collaborators
Wright Medical Technology
Investigators
Principal Investigator: Michael Bolognesi, MD Duke University
  More Information

No publications provided

Responsible Party: Wright Medical Technology
ClinicalTrials.gov Identifier: NCT01367899     History of Changes
Other Study ID Numbers: 09-LJH-002
Study First Received: May 2, 2011
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wright Medical Technology:
Safety
Efficacy

ClinicalTrials.gov processed this record on May 23, 2013