BridgeMD
New treatment option for Elbow Joint Destruction
Official title Clinical Outcomes Study of the Nexel Total Elbow
ClinicalTrials.gov ID: NCT02469662
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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 Patient must have undergone a total elbow replacement with the Nexel system between July...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Golden, Colorado, United States
- Charlotte, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Germantown, Tennessee, United States
- Sydney, New South Wales, Australia
- Tampere, Finland
- Toulouse, France
- Pforzheim, Germany
- Torino, Italy
- Breda, Netherlands
- Wigan, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Golden, Colorado, United States; Charlotte, North Carolina, United States; Philadelphia, Pennsylvania, United States; Germantown, Tennessee, United States; Sydney, New South Wales, Australia; Tampere, Finland and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.