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CONSERVE Plus Post-Approval Study (PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01367899
Recruitment Status : Terminated
First Posted : June 7, 2011
Last Update Posted : October 28, 2014
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

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.

Condition or disease
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

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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
Study Start Date : November 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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

Primary Outcome Measures :
  1. Clinical success at Month 120 [ Time Frame: 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 Outcome Measures :
  1. Radiographic outcomes [ Time Frame: 10 years ]
    Secondary measures: radiographic outcomes

  2. Metal Ion (serum) [ Time Frame: 24 months ]
    metal ion (serum) and renal function will also be collected.

  3. Assessment for Adverse Events [ Time Frame: 10 years ]
    Subjects will be assessed for any adverse events during their length of participation

  4. Measurement of Patient Satisfaction [ Time Frame: 10 years ]
    Patient satisfaction as assessed by the SF-12

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have already undergone hip resurfacing in the CONSERVE Plus IDE.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01367899

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United States, North Carolina
Michael Bolognesi, MD
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
MicroPort Orthopedics Inc.
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Principal Investigator: Michael Bolognesi, MD Duke University

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Responsible Party: MicroPort Orthopedics Inc. Identifier: NCT01367899     History of Changes
Other Study ID Numbers: 09-LJH-002
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

Keywords provided by MicroPort Orthopedics Inc.: