Discovery Elbow Long-Term Survivorship

Terminated

• Conditions: Survivorship; Pain

• Registration Number: NCT01308463
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-07-23
• Study Start: 2011-01
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2016-10-13
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Results First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score	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)
Patient Derived American Shoulder and Elbow Society (ASES) Function	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.
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction	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

Name	Time	Method
Survivorship Will be Measured by the Incidence of Revision or Removals	10 years Post-op	The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed

Trial Locations

Locations (4)

The Indiana Hand to Shoulder Center; 🇺🇸 Indianapolis, Indiana, United States

Florida Orthopedic Institute; 🇺🇸 Tampa, Florida, United States

Vanderbilt Hand Center; 🇺🇸 Nashville, Tennessee, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States