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NCT02469662 | RECRUITING | Elbow Joint Destruction

Clinical Outcomes Study of the Nexel Total Elbow
Sponsor:

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

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

Intervention/treatment

Nexel Total Elbow

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 134 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
Actual Study Start Date : 2015-06
Estimated Primary Completion Date : 2035-12
Estimated Study Completion Date : 2036-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Clinical Outcomes Study of the Nexel Total Elbow

Location Details

NCT02469662

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Panorama Orthopedics and Spine Center

Golden, Colorado, United States, 80401

RECRUITING

United States, North Carolina

OrthoCarolina Research Institute

Charlotte, North Carolina, United States, 28207

RECRUITING

United States, Pennsylvania

Rothman Institute

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Tennessee

Campbell Clinic

Germantown, Tennessee, United States, 38138

TERMINATED

Australia, New South Wales

Sydney Shoulder & Elbow, NSW

Sydney, New South Wales, Australia, 2067

RECRUITING

Finland,

Hospital Thigh

Tampere, Finland,

TERMINATED

France,

PURPAN Hospital (Toulouse University Hospital Center)

Toulouse, France,

TERMINATED

Germany,

Arcus Sportklinik

Pforzheim, Germany,

RECRUITING

Italy,

Ao mauriziano

Torino, Italy, 10128

ACTIVE NOT RECRUITING

Netherlands,

Amphia Hospital Breda

Breda, Netherlands,

RECRUITING

United Kingdom,

Wrightington

Wigan, United Kingdom,