Clinical Outcomes Study of the Nexel Total Elbow

  • STATUS
    Recruiting
  • End date
    Dec 13, 2028
  • participants needed
    120
  • sponsor
    Zimmer Biomet
Updated on 13 August 2020
Investigator
Madison Thompson
Primary Contact
Sydney Shoulder & Elbow, NSW (3.4 mi away) Contact
+11 other location
rheumatoid arthritis

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
Treatment Nexel Total Elbow
Clinical Study IdentifierNCT02469662
SponsorZimmer Biomet
Last Modified on13 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Post Traumatic Arthritis or Post-traumatic Lesions or Ankylosis or Post-traumatic, or Degenerative Arthritis With Incapacitating Pain or Advanced Rheu...?
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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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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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