Clinical Outcomes Study of the Nexel Total Elbow

Post-traumatic Arthritis Clinical Trial

Official title:

Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02469662
• Other study ID #: CMU2014-06E
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2032

Study information

• Verified date: April 2023
• Source: Zimmer Biomet
• Contact: Richard Marek
• Phone: 574-453-7567
• Email: richard.marek[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2032
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty

Locations

Country	Name	City	State
Australia	Sydney Shoulder & Elbow, NSW	Sydney	New South Wales
Finland	Coxa Hospital	Tampere
France	Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)	Toulouse
Germany	Arcus Sportklinik	Pforzheim
Italy	AO Mauriziano	Torino
Netherlands	Amphia Ziekenhuis Breda	Breda
United Kingdom	Wrightington	Wigan
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	Campbell Clinic	Germantown	Tennessee
United States	Panorama Orthopedics and Spine Center	Golden	Colorado
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Australia,  Finland,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	Based on removal or intended removal of the device and determined using the Kaplan-Meier method	10 years