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Joint Replacement
Nexel Total Elbow Replacement for Elbow Osteoarthritis
N/A
Recruiting
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is 18 years of age or older
Patient is a candidate for primary or revision total elbow arthroplasty based on specific symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is to test the safety and performance of the Zimmer Nexel Total Elbow for patients needing either a primary or revision total elbow replacement.
Who is the study for?
This trial is for adults over 18 with severe elbow issues due to conditions like advanced arthritis, joint instability, or fractures that can't be fixed by simpler methods. They must be able to follow the study's schedule and have signed consent. It excludes those with hand dysfunction, mental incompetence, substance abuse problems, non-compliance risk, infections at or near the surgical site, paralysis of the elbow joint area, pregnancy, excessive scarring at surgery site or a history of sepsis.Check my eligibility
What is being tested?
The study aims to confirm the safety and effectiveness of Zimmer Nexel Total Elbow as a replacement in cases where less invasive treatments won't work. This includes both first-time (primary) replacements and redoing (revision) previous replacements when necessary.See study design
What are the potential side effects?
While not explicitly listed in your provided information, typical side effects from similar surgical procedures may include pain at the implant site, swelling around the elbow joint area after surgery which usually decreases over time; there could also be risks associated with anesthesia during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am a candidate for elbow replacement surgery due to my symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survivorship
Trial Design
2Treatment groups
Experimental Treatment
Group I: RetrospectiveExperimental Treatment1 Intervention
Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Group II: ProspectiveExperimental Treatment1 Intervention
Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Find a Location
Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,202 Total Patients Enrolled
Erin OsbornStudy DirectorZimmer Biomet
11 Previous Clinical Trials
12,297 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lot of scarring near where I had surgery, which might affect healing.I engage in activities like heavy labor or sports that could stress an implanted device.I had a total elbow replacement with the Nexel system after July 2013.My joint or soft tissue damage is too severe for successful bone surgery.I am 18 years old or older.I have severe arthritis causing unbearable pain.I have elbow instability due to injury or bone loss.I have had infections at the surgery site before or have one now.I have had sepsis before.I have major difficulty using my hand on the same side as my condition.I am willing and able to attend all follow-up appointments.I have a severe elbow joint fracture that cannot be fixed with simple procedures.I have a serious infection away from where I might have surgery.I have paralysis or nerve damage in my elbow.I am unable to understand or participate in the study due to mental incapacity.I am a candidate for elbow replacement surgery due to my symptoms.My elbow joint damage severely affects my daily activities.I am a candidate for elbow replacement surgery due to my symptoms.I have joints that are stiff and do not move, not due to an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Retrospective
- Group 2: Prospective
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Elbow Osteoarthritis Patient Testimony for trial: Trial Name: NCT02469662 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there open positions for volunteers in this investigation?
"Confirmed. The information on clinicaltrials.gov states that this trial is currently searching for participants and has been doing so since June 1st, 2015. As of October 18th, 2022 the study requires 120 individuals across 4 sites to complete enrollment."
Answered by AI
How many hospitals are operating this trial in the North American region?
"Four primary medical sites are recruiting for this trial, including OrthoCarolina Research Institute in Charlotte, Campbell Clinic in Germantown, and Panorama Orthopedics and Spine Center located in Golden."
Answered by AI
What is the current scale of this clinical trial?
"According to the trial's criteria, 120 suitable candidates are needed for participation. These individuals may sign up at either OrthoCarolina Research Institute in Charlotte or Campbell Clinic based out of Germantown, Tennessee."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
Rothman Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
1
Why did patients apply to this trial?
I’ve tried a number of treatments.
PatientReceived 2+ prior treatments
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