Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
134 participants
INTERVENTIONAL
2015-06-30
2036-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Retrospective
Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Prospective
Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Interventions
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Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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 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.
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Hillary Overholser, MS
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Panorama Orthopedics and Spine Center
Golden, Colorado, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Campbell Clinic
Germantown, Tennessee, United States
Sydney Shoulder & Elbow, NSW
Sydney, New South Wales, Australia
Coxa Hospital
Tampere, , Finland
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse, , France
Arcus Sportklinik
Pforzheim, , Germany
AO Mauriziano
Torino, , Italy
Amphia Ziekenhuis Breda
Breda, , Netherlands
Wrightington
Wigan, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMU2014-06E
Identifier Type: -
Identifier Source: org_study_id
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