search
Back to results

Clinical Outcomes Study of the Nexel Total Elbow

Primary Purpose

Elbow Joint Destruction, Post-traumatic Lesions, Ankylosed Joints

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nexel Total Elbow
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Joint Destruction focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Panorama Orthopedics and Spine CenterRecruiting
  • OrthoCarolina Research InstituteRecruiting
  • Rothman InstituteRecruiting
  • Campbell ClinicRecruiting
  • Sydney Shoulder & Elbow, NSW
  • Coxa HospitalRecruiting
  • Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
  • Arcus Sportklinik
  • AO MaurizianoRecruiting
  • Amphia Ziekenhuis Breda
  • WrightingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Retrospective

Prospective

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2015
Last Updated
April 18, 2023
Sponsor
Zimmer Biomet
search

1. Study Identification

Unique Protocol Identification Number
NCT02469662
Brief Title
Clinical Outcomes Study of the Nexel Total Elbow
Official Title
Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrospective
Arm Type
Experimental
Arm Description
Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Arm Title
Prospective
Arm Type
Experimental
Arm Description
Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Intervention Type
Device
Intervention Name(s)
Nexel Total Elbow
Other Intervention Name(s)
Nexel Elbow, Nexel
Intervention Description
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Primary Outcome Measure Information:
Title
Survivorship
Description
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Marek
Phone
574-453-7567
Email
richard.marek@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Boylan
Phone
574-527-7934
Email
ryan.boylan@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Osborn
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Panorama Orthopedics and Spine Center
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Phillips
Email
rephillips@panoramaortho.com
First Name & Middle Initial & Last Name & Degree
David Schneider, MD
Facility Name
OrthoCarolina Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Marquez
Email
diana.marquez@orthocarolina.com
First Name & Middle Initial & Last Name & Degree
Caleb Michalek
Email
Caleb.Michalek@OrthoCarolina.com
First Name & Middle Initial & Last Name & Degree
Nady Hamid, MD
First Name & Middle Initial & Last Name & Degree
Patrick Connor, MD
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thema Nicholson
Email
thema.nicholson@rothmaninstitute.com
First Name & Middle Initial & Last Name & Degree
Surena Namdari, MD
First Name & Middle Initial & Last Name & Degree
Matthew Ramsey, MD
Facility Name
Campbell Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Knack
Email
mknack@campbell-foundation.org
First Name & Middle Initial & Last Name & Degree
Thomas W Throckmorton, MD
Facility Name
Sydney Shoulder & Elbow, NSW
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Individual Site Status
Terminated
Facility Name
Coxa Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pirjo Honkanen, MD
Facility Name
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
City
Toulouse
Country
France
Individual Site Status
Terminated
Facility Name
Arcus Sportklinik
City
Pforzheim
Country
Germany
Individual Site Status
Terminated
Facility Name
AO Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Blonna
Phone
+39 011 508 1111
Email
davide.blonna@virgilio.it
First Name & Middle Initial & Last Name & Degree
Davide Blonna, MD
Facility Name
Amphia Ziekenhuis Breda
City
Breda
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Wrightington
City
Wigan
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Watts, MBBS

12. IPD Sharing Statement

Learn more about this trial

Clinical Outcomes Study of the Nexel Total Elbow

We'll reach out to this number within 24 hrs