Back to Trials
NCT02469662NARecruiting

Clinical Outcomes Study of the Nexel Total Elbow

Zimmer Biomet

Start Date

6/1/2015

Completion Date

12/1/2036

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Nexel Total Elbow

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

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 Arthritis

Locations

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

Sydney Shoulder & Elbow, NSW

Sydney, New South Wales 2067

Australia

Coxa Hospital

Tampere,

Finland

Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)

Toulouse,

France

Arcus Sportklinik

Pforzheim,

Germany

AO Mauriziano

Torino, 10128

Italy

Amphia Ziekenhuis Breda

Breda,

Netherlands

Wrightington

Wigan,

United Kingdom