Discovery Elbow Long-Term Survivorship

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01308463
First received: July 23, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention
Function
Pain
Device: Discovery elbow minimally constrained

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovery Elbow Long-Term Survivorship Study

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Patient ASES Assessment [ Time Frame: 10 years - 15 years ] [ Designated as safety issue: No ]
    This patient questionnaire asks questions related to pain, range of motion, work and sports activity.


Secondary Outcome Measures:
  • Survivorship will be measured by the incidence of revision or removals [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Discovery Elbow
Discovery Minimally constrained elbow
Device: Discovery elbow minimally constrained
patient participating in the Discovery Elbow Multi-center study

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308463

Contacts
Contact: Russell Schenck, PhD 574-371-1146 russell.schenck@biomet.com
Contact: Carol Lauster (574) 372-1913 carol.lauster@biomet.com

Locations
United States, Florida
Florida Orthopedic Institute Recruiting
Tampa, Florida, United States, 33637
United States, Indiana
The Indiana Hand to Shoulder Center Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Tennessee
Vanderbilt Hand Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell Schenck, PhD Director Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01308463     History of Changes
Other Study ID Numbers: 400
Study First Received: July 23, 2010
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
elbow long-term survivorship
Study participant Discovery Elbow Multi-center Study who
consent for the Discovery Elbow Long-term Survivorship Study

ClinicalTrials.gov processed this record on August 27, 2014