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Discovery Elbow Long-Term Survivorship

This study is currently recruiting participants.
Verified February 2013 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01308463
First received: July 23, 2010
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  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
Activities of Daily Living
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 question 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308463

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

Locations
United States, Florida
Florida Orthopedic Institute Recruiting
Tampa, Florida, United States, 33637
Principal Investigator: Mark Mighell, MD            
United States, Indiana
The Indiana Hand to Shoulder Center Recruiting
Indianapolis, Indiana, United States, 46260
Principal Investigator: Hill Hastings, MD            
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: David Ring, MD            
Sub-Investigator: Jesse Jupiter, MD            
United States, Tennessee
Vanderbilt Hand Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Donald H. Lee, MD            
Sub-Investigator: Douglas R. Weikert, MD            
Sub-Investigator: Jeffry T. Watson, MD            
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: February 1, 2013
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 May 19, 2013