Discovery Elbow Long-Term Survivorship

Pain Clinical Trial

Official title:

Discovery Elbow Long-Term Survivorship Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01308463
• Other study ID #: ORTHO.CR.EX002
• Status: Terminated
• Phase: N/A
• First received: July 23, 2010
• Last updated: September 23, 2016
• Start date: January 2011
• Est. completion date: December 2020

Study information

• Verified date: December 2015
• Source: Biomet, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Survivorship

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Indiana Hand to Shoulder Center	Indianapolis	Indiana
United States	Vanderbilt Hand Center	Nashville	Tennessee
United States	Florida Orthopedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biomet, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient ASES Assessment	This patient questionnaire asks questions related to pain, range of motion, work and sports activity.	10 years - 15 years	No
Secondary	Survivorship will be measured by the incidence of revision or removals	The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed	10 years	Yes