Clinical Outcomes Study of the Nexel Total Elbow

Zimmer Biomet

Status: Enrolling

Conditions: Post-traumatic Lesions; Ankylosed Joints; Advanced Rheumatoid Arthritis; Degenerative Arthritis; Bone Loss Contributing to Elbow Instability; Bilateral Ankylosis From Causes Other Than Active Sepsis; Elbow Joint Destruction; Joint Instability or Loss of Motion; Post-traumatic Arthritis; Acute Comminuted Articular Fracture of Elbow Joint Surfaces

Treatments: Device: Nexel Total Elbow

Study type: Interventional

Funder types: Industry

Identifiers

NCT02469662

CMU2014-06E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

134 participants in 2 patient groups

Retrospective

Experimental group

Description:

Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available

Treatment:

Device: Nexel Total Elbow

Prospective

Experimental group

Description:

Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow

Treatment:

Device: Nexel Total Elbow