Clinical Outcomes Study of the Nexel Total Elbow

  • STATUS
    Recruiting
  • End date
    Dec 20, 2028
  • participants needed
    120
  • sponsor
    Zimmer Biomet
Updated on 20 July 2021
rheumatoid arthritis
joint reconstruction

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.

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.

Details
Condition Ankylosis, Osteoarthritis, Post Traumatic Arthritis, Elbow Joint Destruction, Post-traumatic Lesions, 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, or Degenerative Arthritis With Incapacitating Pain, Post-traumatic Lesions, Post-traumatic Lesions, Post-traumatic Lesions, degenerative arthritis, ankyloses, Post-traumatic Lesions, Post-traumatic Lesions, Post-traumatic Lesions
Treatment Nexel Total Elbow
Clinical Study IdentifierNCT02469662
SponsorZimmer Biomet
Last Modified on20 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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