RECRUITING

Clinical Outcomes Study of the Nexel Total Elbow

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Conditions

Elbow Joint DestructionPost-traumatic LesionsAnkylosed JointsAdvanced Rheumatoid ArthritisJoint Instability or Loss of MotionAcute Comminuted Articular Fracture of Elbow Joint SurfacesBone Loss Contributing to Elbow InstabilityBilateral Ankylosis From Causes Other Than Active SepsisPost-traumatic ArthritisDegenerative ArthritisTotal Elbow ArthroplastyTEAElbow ArthroplastyElbow ReplacementPost-Traumatic Lesions or Bone LossAcute Comminuted Articular FractureSignificantly compromises daily living activitiesJoint or soft tissue damagePrecludes less radical procedures13-C3 fractures of the distal humerus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

Official Title

Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

Quick Facts

Study Start:2015-06
Study Completion:2035-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02469662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is 18 years of age or older.
  2. * Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.
  3. * Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:
  4. * Elbow joint destruction which significantly compromises daily living activities
  5. * Post-traumatic lesions or bone loss contributing to elbow instability
  6. * Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis
  7. * Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain
  8. * Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
  9. * Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
  10. * Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.
  11. * Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.
  12. * Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted.
  1. * Patient has a currently active or history of repeated local infection at the surgical site.
  2. * Patient has a current major infection distant from the operative site.
  3. * Patient has a history of prior sepsis.
  4. * Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
  5. * Patient has significant ipsilateral hand dysfunction.
  6. * Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.
  7. * Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and/or competitive sports.
  8. * Patient is a prisoner.
  9. * Patient is mentally incompetent or unable to understand what participation in the study entails.
  10. * Patient is a known alcohol or drug abuser.
  11. * Patient is anticipated to be non-compliant.
  12. * Patient is known to be pregnant.

Contacts and Locations

Study Contact

Richard Marek
CONTACT
574-453-7567
richard.marek@zimmerbiomet.com
Ryan Boylan
CONTACT
574-527-7934
ryan.boylan@zimmerbiomet.com

Principal Investigator

Erin Osborn
STUDY_DIRECTOR
Zimmer Biomet

Study Locations (Sites)

Panorama Orthopedics and Spine Center
Golden, Colorado, 80401
United States
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
United States
Rothman Institute
Philadelphia, Pennsylvania, 19107
United States
Campbell Clinic
Germantown, Tennessee, 38138
United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

  • Erin Osborn, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06
Study Completion Date2035-12

Study Record Updates

Study Start Date2015-06
Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

  • Total Elbow Arthroplasty
  • TEA
  • Elbow Arthroplasty
  • Elbow Replacement
  • Advanced Rheumatoid Arthritis
  • Post-Traumatic Arthritis
  • Degenerative Arthritis
  • Elbow Joint Destruction
  • Post-Traumatic Lesions or Bone Loss
  • Ankylosed Joints
  • Acute Comminuted Articular Fracture
  • Significantly compromises daily living activities
  • Joint or soft tissue damage
  • Precludes less radical procedures
  • 13-C3 fractures of the distal humerus

Additional Relevant MeSH Terms

  • Elbow Joint Destruction
  • Post-traumatic Lesions
  • Ankylosed Joints
  • Advanced Rheumatoid Arthritis
  • Joint Instability or Loss of Motion
  • Acute Comminuted Articular Fracture of Elbow Joint Surfaces
  • Bone Loss Contributing to Elbow Instability
  • Bilateral Ankylosis From Causes Other Than Active Sepsis
  • Post-traumatic Arthritis
  • Degenerative Arthritis