Health Trials

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

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

Treatments tested in this trial

  • Nexel Total Elbow

Treatment groups

134 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zimmer Biomet

Lead sponsor

Source ClinicalTrials.gov