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Clinical Outcomes Study of the Nexel Total Elbow

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2015-06-01

Primary completion: 2027-12-01

Study completion finish: 2035-12-01

Study type

TREATMENT

Phase

Trial ID

NCT02469662

Intervention or treatment

DEVICE: Nexel Total Elbow

Conditions

• 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

Image related to Elbow Joint Destruction

Condition: Elbow Joint Destruction, Post-traumatic Lesions and more
DEVICE: Nexel Total Elbow
Sydney, New South Wales, Australia
Sponsor: Zimmer Biomet

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Find a site

Closest Location:

Sydney Shoulder & Elbow, NSW

Research sites nearby

Select from list below to view details:

Sydney Shoulder & Elbow, NSW
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Retrospective Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available	DEVICE: Nexel Total Elbow Nexel Total Elbow used in primary or revision total elbow arthroplasty
EXPERIMENTAL: Prospective Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow	DEVICE: Nexel Total Elbow Nexel Total Elbow used in primary or revision total elbow arthroplasty

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Survivorship	Based on removal or intended removal of the device and determined using the Kaplan-Meier method	10 years

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Clinical Outcomes Study of the Nexel Total Elbow