Discovery Elbow Long-Term Survivorship

NCT ID: NCT01308463

Last Updated: 2017-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Survivorship Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Discovery elbow minimally constrained

patient participating in the Discovery Elbow Multi-center study

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Russell Schenck, PhD

Role: STUDY_DIRECTOR

Director Clinical Research, Biomet Orthopedics, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida Orthopedic Institute

Tampa, Florida, United States

Site Status

The Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Vanderbilt Hand Center

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ORTHO.CR.EX002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

INFINITY™ With ADAPTIS™ Technology Study
NCT04594993 ACTIVE_NOT_RECRUITING
Long Term Sidus PMCF
NCT04063943 WITHDRAWN NA
Zimmer Trabecular Metal Total Ankle PMCF
NCT02038140 ACTIVE_NOT_RECRUITING NA
Encore Revelation Hip Stem
NCT01514318 COMPLETED
Comprehensive SRS Regenerex Tissue Attachment
NCT06615739 ACTIVE_NOT_RECRUITING
MDR ExploR Radial Head System PMCF
NCT05583448 ENROLLING_BY_INVITATION