Comprehensive SRS Regenerex Tissue Attachment

Launched by ZIMMER BIOMET · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Comprehensive SRS Regenerex Tissue Attachment, which is used during surgeries to address serious shoulder problems, particularly after previous treatments have not worked. The goal of the study is to confirm that this treatment is safe and effective for patients who have issues like arthritis, bone loss from tumors, or complex fractures that cannot be treated with standard methods. By participating in this trial, patients may have the chance to receive this innovative treatment and contribute to research that could help others in the future.

To be eligible for this trial, participants must be 18 years or older and able to follow medical directions. They should have specific shoulder conditions addressed by the Comprehensive Segmental Revision System, a specialized device used in surgery. However, some individuals, such as those with certain infections or serious mental health issues, may not be able to participate. If you join the trial, you'll work closely with healthcare providers who will monitor your progress and ensure your safety throughout the study. This is an important opportunity to possibly improve your shoulder function and help advance medical knowledge in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be 18 years of age or older.
• • Patient must be willing and able to follow directions.
• * The Comprehensive Segmental Revision System was used in cases of:
• • 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• • 2. Revision where other devices or treatments have failed.
• • 3. Correction of functional deformity.
• • 4. Oncology applications including bone loss due to tumor resection.
• • Proximal or total humeral replacement, for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
• • Distal or total humeral replacement for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
• • Biomet Comprehensive Segmental Revision System was used in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff for proximal humeral replacement. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
• • The Comprehensive Segmental Revision System was used with bone cement in distal humeral and total humeral applications.
• • Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision System
• Exclusion Criteria:
• * Absolute contraindications:
• • Infection
• • Sepsis
• • Osteomyelitis
• • Patient is a prisoner
• • Patient is a current alcohol or drug abuser
• • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• • Patient is unwilling to consent
• * Relative contraindications:
• • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• • Osteoporosis
• • Metabolic disorders which may impair bone formation
• • Osteomalacia
• • Distant foci of infections which may spread to the implant site
• • Vascular insufficiency, muscular atrophy, or neuromuscular disease
• • The Comprehensive Segmental Revision System was used in a reverse shoulder application in patients receiving radiation therapy
• • The Comprehensive Segmental Revision System was used without bone cement in distal humeral and total humeral applications.
• • Regenerex Tissue Attachment Augments weren't used during the patient's surgery