Discovery Elbow Long-Term Survivorship

NCT01308463 | Terminated Results

• 1 other identifier: ORTHO.CR.EX002
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 4

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.

Conditions

Survivorship; Pain

Keywords

elbow long-term Survivorship; Study participant Discovery Elbow Multi-center Study who; consent for the Discovery Elbow Long-term SurvivorshipStudy

Outcome Measures

Primary Outcomes (3)

• Patient Derived American Shoulder and Elbow Society (ASES) Pain Score

  This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)

  10 Years Post-op

• Patient Derived American Shoulder and Elbow Society (ASES) Function

  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.

  10 Years Post-op

• Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction

  This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.

  10 Years Post-op

Secondary Outcomes (1)

• Survivorship Will be Measured by the Incidence of Revision or Removals

  10 years Post-op

Interventions

Discovery elbow minimally constrained DEVICE

patient participating in the Discovery Elbow Multi-center study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Participant in the Discovery Elbow Multi-center Study
• Consent to participate in the Discovery Elbow Long-Term Survivorship Study

You may not qualify if:

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Florida Orthopedic Institute

Tampa, Florida, 33637, United States

Location

The Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Vanderbilt Hand Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The early termination of this study lead to only a small number of consenting subjects available for analysis.

Results Point of Contact

• Title: Kelly Francher
• Organization: Zimmer Biomet

kelly.francher@zimmerbiomet.com

574-371-9783

Study Officials

• Russell Schenck, PhD

  Director Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: March 4, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 1, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-03

Locations

US (4)