Nexel Total Elbow Replacement for Elbow Osteoarthritis

Recruiting at 8 trial locations

Overseen By Matthew Ramsey, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Infection, Paralysis, Hand dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called the Nexel Total Elbow for individuals needing a new elbow joint due to severe arthritis or other serious joint issues. The goal is to ensure the treatment's safety and effectiveness for those requiring primary or revision elbow replacement surgery. Suitable candidates have severe elbow problems that hinder daily activities, such as joint destruction, instability, or advanced arthritis causing significant pain. Participants will join either a retrospective group (those who had the surgery previously) or a prospective group (those scheduled for future surgery). As an unphased trial, this study allows participants to contribute to valuable research that could enhance future elbow replacement treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that the Nexel Total Elbow is safe for elbow osteoarthritis?

Research has shown mixed safety results for the Nexel Total Elbow replacement. One study reported a 100% success rate, with no replacement surgeries needed and few complications. Another study found a 96.9% success rate after one year, which is quite high.

However, not all results are positive. Some reports mentioned a high rate of early problems, such as the implant becoming loose or breaking. These mixed results suggest that while many patients do well with the Nexel, concerns exist about its early performance.

When considering this treatment, patients should weigh these findings and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for elbow osteoarthritis, which often involves traditional elbow replacement surgeries, the Nexel Total Elbow offers a potentially more advanced approach. This treatment is unique because it focuses on both primary and revision total elbow arthroplasty, promising improved joint function and longevity. Researchers are excited about the Nexel Total Elbow's design and materials, which aim to enhance the range of motion and durability compared to existing options. Additionally, the new surgical techniques associated with this treatment could lead to better patient outcomes and faster recovery times.

What evidence suggests that the Nexel Total Elbow is effective for elbow osteoarthritis?

This trial will evaluate the Nexel Total Elbow replacement for treating elbow osteoarthritis. Research has shown mixed results for the Nexel Total Elbow replacement. One study found that all implants lasted without needing replacement for a certain period. However, other studies reported a high rate of early problems, such as the implant becoming loose or breaking. In the short term, many patients expressed satisfaction, but complications were common, and some required further surgery. Overall, while some patients do well with this implant, others may face significant issues. Participants in this trial will join either a retrospective arm, involving patients who have already had the surgery, or a prospective arm, involving patients who will receive the Nexel Total Elbow. ^{1 2 4 6 7}

Who Is on the Research Team?

Hillary Overholser, MS

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent

I had a total elbow replacement with the Nexel system after July 2013.

I am willing and able to attend all follow-up appointments.

Exclusion 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.

Patient is known to be pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive primary or revision total elbow arthroplasty using the Nexel Total Elbow

Surgical procedure

Follow-up

Participants are monitored for safety and performance of the Nexel Total Elbow, including pain and functional performance, survival of the device, patient health status, and radiographic success

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Nexel Total Elbow

Trial Overview 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.

How Is the Trial Designed?

Group I: Retrospective Experimental Treatment 1 Intervention

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

Group II: Prospective Experimental Treatment 1 Intervention

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

Nexel Total Elbow is already approved in United States, European Union for the following indications:

Approved in United States as Zimmer Nexel Total Elbow for:

• Primary total elbow replacement
• Revision total elbow replacement
• Elbow joint destruction
• Post-traumatic lesions or bone loss contributing to elbow instability
• Ankylosed joints
• Advanced rheumatoid, 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 the elbow joint surfaces

Approved in European Union as Zimmer Nexel Total Elbow for:

• Primary total elbow replacement
• Revision total elbow replacement
• Elbow joint destruction
• Post-traumatic lesions or bone loss contributing to elbow instability
• Ankylosed joints
• Advanced rheumatoid, 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 the elbow joint surfaces

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Published Research Related to This Trial

Elbow replacement arthroplasty is now a standard treatment for various elbow diseases, including trauma, with long-term outcomes showing about 90% survival rates at 10 years, similar to other joint replacements.

Common complications associated with elbow implants include infection, aseptic loosening, and prosthetic failure, highlighting the importance of monitoring patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of elbow replacement arthroplasty. Roth, E., Chew, FS.[2022]

Total elbow arthroplasty is effective for treating complex distal humerus fractures in elderly patients, but outcomes are generally worse compared to those in rheumatic patients, highlighting the need for careful pre-operative assessment of bone defects.

In cases of significant bone loss, allografts or tumor prostheses can be used, but these salvage procedures come with less predictable results and higher complication rates, indicating a need for caution in such scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Total elbow arthroplasty in traumatic and post-traumatic bone defects]. Hackl, M., Müller, LP., Leschinger, T., et al.[2022]

The Discovery Elbow System is designed to closely match natural elbow movement and preserve important ligaments, which helps improve the function and comfort of the joint after replacement.

Elbow replacements generally provide a reliable restoration of pain-free motion, especially in low-demand patients, but the decision to use this system should consider the patient's age and activity level for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally constrained elbow implant arthroplasty: the discovery elbow system. Hastings, H.[2022]

A nonconstrained total elbow replacement system was developed for dogs suffering from chronic elbow osteoarthritis that did not respond to medical treatment for at least one year, indicating a new surgical option for these cases.

Refinements in the design of the elbow replacement components led to improved long-term functional outcomes, suggesting that this surgical intervention can be effective in enhancing the quality of life for affected dogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonconstrained elbow replacement in dogs. Conzemius, M.[2011]

Elbow replacement has become a valuable option for restoring function in elderly patients with complex elbow injuries, especially those with osteoporosis and poor bone healing.

The article discusses the latest-generation Discovery Elbow System, highlighting its design improvements and addressing potential complications associated with semiconstrained implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total elbow replacement for distal humerus fractures and traumatic deformity: results and complications of semiconstrained implants and design rationale for the Discovery Elbow System. Hastings, H., Theng, CS.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02469662

Clinical Outcomes Study of the Nexel Total Elbow 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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1045452722000335

Survivorship and clinical outcomes of total elbow ... The current study reports 100% implant survival, with revision or indication for revision as the endpoint, and low rates of complications with an average of 53 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9264017/

Unexpected high early failure rate of the Nexel total elbow ... Primary TEA with implantation of this implant was associated with an unacceptably high rate of early implant loosening, periprosthetic fracture, and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33675969/

Short-term outcomes of the Nexel total elbow arthroplasty The short-term clinical results of the Nexel TEA are satisfactory. However, an unusually high rate of complications and revisions was observed.

5. withpower.com withpower.com/trial/phase-intra-articular-fractures-5-2015-a4464

Nexel Total Elbow Replacement for Elbow Osteoarthritis This trial aims to confirm the safety and effectiveness of the Zimmer Nexel Total Elbow in patients needing their first or a revised elbow replacement.

6. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(21)00150-6/abstract

Short-term outcomes of the Nexel total elbow arthroplasty Third-generation total elbow arthroplasties (TEAs) have shown better mechanical characteristics than older designs. However, these results ...

7. zimmerbiomet.lat zimmerbiomet.lat/content/dam/zimmer-biomet/medical-professionals/elbow/nexel-total-elbow/Nexel%20Elbow%202019%20Annual%20Report%20White%20Paper.pdf

Retrospective and Prospective Clinical Outcomes Study of the ... The primary total elbow arthroplasty survival for the. Nexel Elbow implant is 96.9% at 1 year. Literature reports survivorship of 94.9% calculated from ...