Clinical trial NCT02469662: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Survivorship
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Golden
country: United States
facility: Panorama Orthopedics and Spine Center
state: Colorado
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
city: Sydney
country: Australia
facility: Sydney Shoulder & Elbow, NSW
state: New South Wales
city: Tampere
country: Finland
facility: Coxa Hospital
city: Toulouse
country: France
facility: Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
city: Pforzheim
country: Germany
facility: Arcus Sportklinik
city: Torino
country: Italy
facility: AO Mauriziano
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda
city: Wigan
country: United Kingdom
facility: Wrightington
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: