Health TrialsbyHealthPanel

Clinical Outcomes Study of the Nexel Total Elbow

ConditionsElbow Joint DestructionPost-traumatic LesionsAnkylosed JointsAdvanced Rheumatoid ArthritisJoint Instability or Loss of MotionAcute Comminuted Articular Fracture of Elbow Joint SurfacesBone Loss Contributing to Elbow InstabilityBilateral Ankylosis From Causes Other Than Active SepsisPost-traumatic ArthritisDegenerative Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZimmer Biomet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is 18 years of age or older.

Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.

Elbow joint destruction which significantly compromises daily living activities

Post-traumatic lesions or bone loss contributing to elbow instability

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nexel Total Elbow

    Device

    Nexel Total Elbow used in primary or revision total elbow arthroplasty

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: RetrospectiveExperimental treatment 1 intervention
Group B: ProspectiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survivorship

Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zimmer Biomet

Lead sponsor

Source ClinicalTrials.gov
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