Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

STATUS

Recruiting
End date

Dec 28, 2032
participants needed

120
sponsor

Zimmer Biomet

Updated on 28 October 2022

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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	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
Treatment	Nexel Total Elbow
Clinical Study Identifier	NCT02469662
Sponsor	Zimmer Biomet
Last Modified on	28 October 2022

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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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Step 2 Get screened

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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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Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow