Recruiting

Nexel Total Elbow

Sponsor:

Zimmer Biomet

Code:

NCT02469662

Conditions

Elbow Joint Destruction

Post-traumatic Lesions

Ankylosed Joints

Advanced Rheumatoid Arthritis

Joint Instability or Loss of Motion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nexel Total Elbow

Study Details

Brief 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.

Conditions

Elbow Joint Destruction

Post-traumatic Lesions

Ankylosed Joints

Advanced Rheumatoid Arthritis

Joint Instability or Loss of Motion

Study ID

NCT02469662

Start date

Jun, 2015

Status verified date

Jul, 2026

Completion date

Dec, 2036

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

134 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Retrospective

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

experimental: Prospective

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

Interventions

Nexel Total Elbow

Nexel Total Elbow used in primary or revision total elbow arthroplasty

Primary outcome measure

  • Survivorship [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Richard Marek

574-453-7567richard.marek@zimmerbiomet.com

Ryan Boylan

574-527-7934ryan.boylan@zimmerbiomet.com

Locations

Panorama Orthopedics and Spine Center

Recruiting

Golden, Colorado, United States, 80401

Contacts

Paul Lee

Paul.Lee@panoramaortho.com

Principal Investigator:

David Schneider, MD

OrthoCarolina Research Institute

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Caleb Lifsey

704-323-2262Caleb.Lifsey@orthocarolina.com

Justin Norwood

704-323-3845Justin.Norwood@orthocarolina.com

Principal Investigator:

Nady Hamid, MD

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Anuhya Peruri

267-386-2474Anuhya.Peruri@rothmanortho.com

Thema Nicholson

thema.nicholson@rothmaninstitute.com

Principal Investigator:

Surena Namdari, MD

Campbell Clinic

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Margaret Knack

mknack@campbell-foundation.org

Principal Investigator:

Thomas W Throckmorton, MD

More Information

Sponsor

Zimmer Biomet

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Total Elbow Arthroplasty
  • TEA
  • Elbow Arthroplasty
  • Elbow Replacement
  • Advanced Rheumatoid Arthritis
  • Post-Traumatic Arthritis
  • Degenerative Arthritis
  • Elbow Joint Destruction
  • Post-Traumatic Lesions or Bone Loss
  • Ankylosed Joints
  • Acute Comminuted Articular Fracture
  • Significantly compromises daily living activities
  • Joint or soft tissue damage
  • Precludes less radical procedures
  • 13-C3 fractures of the distal humerus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2026-07-09.