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Clinical Outcomes Study of the Nexel Total Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469662
Recruitment Status : Recruiting
First Posted : June 11, 2015
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Device: Nexel Total Elbow Not Applicable

Detailed 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 by analysis of standard scoring systems, radiographs, and adverse event records.

The safety of the device will be monitored using the frequency and incidence of reporting adverse events.

The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
Study Start Date : June 2015
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2028

Arm Intervention/treatment
Experimental: Retrospective
Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Device: Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Other Names:
  • Nexel Elbow
  • Nexel

Experimental: Prospective
Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Device: Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Other Names:
  • Nexel Elbow
  • Nexel




Primary Outcome Measures :
  1. Survivorship [ Time Frame: 10 years ]
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is 18 years of age or older.
  • Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.
  • Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:

    • Elbow joint destruction which significantly compromises daily living activities
    • Post-traumatic lesions or bone loss contributing to elbow instability
    • Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis
    • Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain
    • Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
    • Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
  • Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.

Additional Retrospective Arm Inclusion Criteria

  • Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.
  • 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.

Exclusion Criteria:

  • Patient has a currently active or history of repeated local infection at the surgical site.
  • Patient has a current major infection distant from the operative site.
  • Patient has a history of prior sepsis.
  • Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
  • Patient has significant ipsilateral hand dysfunction.
  • Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.
  • Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and/or competitive sports.
  • Patient is a prisoner.
  • Patient is mentally incompetent or unable to understand what participation in the study entails.
  • Patient is a known alcohol or drug abuser.
  • Patient is anticipated to be non-compliant.
  • Patient is known to be pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469662


Contacts
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Contact: Madison Thompson 574-373-2265 madison.thompson@zimmerbiomet.com
Contact: Kacy Arnold, RN MBA 574-371-9824 kacy.arnold@zimmerbiomet.com

Locations
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United States, Colorado
Panorama Orthopedics and Spine Center Not yet recruiting
Golden, Colorado, United States, 80401
Contact: Marlie Mounts    720-497-6697    mmounts@panoramaortho.com   
Principal Investigator: David Schneider, MD         
United States, North Carolina
OrthoCarolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Caleb Michalek, CCRC       Caleb.Michalek@OrthoCarolina.com   
Principal Investigator: Nady Hamid, MD         
Sub-Investigator: Patrick Connor, MD         
United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Thema Nicholson       thema.nicholson@rothmaninstitute.com   
Principal Investigator: Surena Namdari, MD         
Sub-Investigator: Matthew Ramsey, MD         
United States, Tennessee
Campbell Clinic Recruiting
Germantown, Tennessee, United States, 38138
Contact: Margaret Knack       mknack@campbell-foundation.org   
Principal Investigator: Thomas W Throckmorton, MD         
Australia, New South Wales
Sydney Shoulder & Elbow, NSW Recruiting
Sydney, New South Wales, Australia, 2067
Principal Investigator: Jeffery Hughes         
Finland
Coxa Hospital Recruiting
Tampere, Finland
Principal Investigator: Pirjo Honkanen, MD         
France
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse) Recruiting
Toulouse, France
Principal Investigator: Pierre Mansat         
Germany
Arcus Sportklinik Recruiting
Pforzheim, Germany
Principal Investigator: Boris Hollinger, MD         
Italy
Hesperia Hospital Not yet recruiting
Modena, Italy, 41100
Principal Investigator: Andrea Celli, MD         
Netherlands
Amphia Ziekenhuis Breda Recruiting
Breda, Netherlands
Principal Investigator: Denise Eyendaal, MD         
United Kingdom
Wrightington Recruiting
Wigan, United Kingdom
Principal Investigator: Adam Watts, MBBS         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Erin Osborn Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02469662    
Other Study ID Numbers: CMU2014-06E
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Keywords provided by Zimmer Biomet:
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:
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Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Instability
Ankylosis
Fractures, Comminuted
Intra-Articular Fractures
Joint Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases