What side effects are associated with this type of intervention?

Common treatments for elbow osteoarthritis include surgical options like total elbow replacement (e.g., Zimmer Nexel Total Elbow) and non-surgical options such as NSAIDs, glucocorticoid injections, and physical therapy. Total elbow replacement can lead to complications such as infection, prosthetic loosening, and nerve damage. NSAIDs may cause gastrointestinal issues, cardiovascular risks, and kidney problems. Glucocorticoid injections can provide short-term relief but may result in tendon weakening and increased recurrence of symptoms. Physical therapy generally has minimal side effects but may cause temporary discomfort.

What prior FDA approvals exist?

The FDA has approved various treatments for elbow osteoarthritis, including prosthetic devices for total elbow replacement. One such device is the Zimmer Nexel Total Elbow, which is designed for both primary and revision total elbow replacement. These prosthetic devices aim to restore function and alleviate pain in patients with severe elbow osteoarthritis. Other treatments may include corticosteroid injections and NSAIDs, although these are more commonly used for pain management rather than structural replacement.

What other types of research exist?

Promising alternatives to the Zimmer Nexel Total Elbow for elbow osteoarthritis patients include the Norway elbow prosthesis, which is a non-constrained cemented total replacement allowing a full range of movement and providing semi-constraint with a locking ring if needed. Additionally, advancements in minimally invasive surgical techniques and custom 3D-printed prosthetics are emerging as novel options, offering personalized fit and potentially improved outcomes.

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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

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. The device replaces damaged parts of the elbow to help reduce pain and improve function. The Zimmer Nexel Total Elbow is used to replace damaged parts of the elbow, primarily in patients with severe elbow pain and joint destruction.

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.

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.

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 below

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I am 18 years old or older.

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I am a candidate for elbow replacement surgery due to my symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lot of scarring near where I had surgery, which might affect healing.

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I engage in activities like heavy labor or sports that could stress an implanted device.

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I have a serious infection away from where I might have surgery.

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I have paralysis or nerve damage in my elbow.

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I am unable to understand or participate in the study due to mental incapacity.

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I have had infections at the surgery site before or have one now.

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I have had sepsis before.

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I have major difficulty using my hand on the same side as my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survivorship

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for elbow osteoarthritis include nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, corticosteroid injections, and surgical interventions such as total elbow replacement. NSAIDs work by reducing inflammation and pain through the inhibition of cyclooxygenase enzymes. Physical therapy aims to improve joint function and reduce pain through targeted exercises and mobilization techniques. Corticosteroid injections provide short-term pain relief by reducing inflammation directly within the joint. Total elbow replacement, such as the Zimmer Nexel Total Elbow, involves replacing the damaged joint surfaces with prosthetic components, which can significantly reduce pain and improve joint function. These treatments are crucial for managing symptoms, maintaining joint mobility, and improving the quality of life for patients with elbow osteoarthritis.

[The experience of the using Tolperisone in a complex conservative therapy of an osteoarthrosis of a hip joint].