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Discovery Elbow Long-Term Survivorship

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ClinicalTrials.gov Identifier: NCT01308463
Recruitment Status : Terminated (Study terminated due to change in sponsorship)
First Posted : March 4, 2011
Results First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.

Condition or disease Intervention/treatment
Survivorship Pain Device: Discovery elbow minimally constrained

Detailed Description:

Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.

In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.


Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovery Elbow Long-Term Survivorship Study
Study Start Date : January 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Intervention Details:
    Device: Discovery elbow minimally constrained
    patient participating in the Discovery Elbow Multi-center study


Primary Outcome Measures :
  1. Patient Derived American Shoulder and Elbow Society (ASES) Pain Score [ Time Frame: 10 Years Post-op ]
    This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)

  2. Patient Derived American Shoulder and Elbow Society (ASES) Function [ Time Frame: 10 Years Post-op ]
    This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.

  3. Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction [ Time Frame: 10 Years Post-op ]

    This is the patient's perception of satisfaction with the elbow replacement surgery.

    Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.



Secondary Outcome Measures :
  1. Survivorship Will be Measured by the Incidence of Revision or Removals [ Time Frame: 10 years Post-op ]
    The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Study population shall be participanting in the Discovery Elbow Multi-center Study who provide consent for the Discovey Elbow Long-term Survivoship Study
Criteria

Inclusion Criteria:

  1. Participant in the Discovery Elbow Multi-center Study
  2. Consent to participate in the Discovery Elbow Long-Term Survivorship Study

Exclusion Criteria:

  1. Patient is not a Discovery Elbow Multi-center Participant
  2. Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study

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 ClinicalTrials.gov identifier (NCT number): NCT01308463


Locations
United States, Florida
Florida Orthopedic Institute
Tampa, Florida, United States, 33637
United States, Indiana
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Tennessee
Vanderbilt Hand Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Russell Schenck, PhD Director Clinical Research, Biomet Orthopedics, LLC

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01308463     History of Changes
Other Study ID Numbers: ORTHO.CR.EX002
First Posted: March 4, 2011    Key Record Dates
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017
Last Verified: March 2017

Keywords provided by Zimmer Biomet:
elbow long-term Survivorship
Study participant Discovery Elbow Multi-center Study who
consent for the Discovery Elbow Long-term SurvivorshipStudy