Evaluating a new tissue attachment device for shoulder surgeries
PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System (SRS) Regenerex Tissue Attachment Augments - A Retrospective Enrollment and Prospective Follow-up Consecutive Series Study
Zimmer Biomet · NCT06615739
This study is testing a new device used in shoulder surgeries to see how safe and effective it is for patients who receive it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet (industry) |
| Drugs / interventions | radiation |
| Locations | 1 site (Boca Raton, Florida) |
| Trial ID | NCT06615739 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the safety and performance of the Comprehensive SRS Regenerex Tissue Attachment Augments used in limb salvage arthroplasty. It will involve both retrospective and prospective data collection from consecutive patients who have received the implant. The primary focus is to assess implant survivorship by tracking revisions, complications, and adverse events related to the device. The study will be conducted at a single site with a maximum enrollment of 103 patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require shoulder or elbow replacement due to severe joint issues or failed previous treatments.
Not a fit: Patients with inflammatory joint diseases or those who do not meet the specific surgical criteria for the Comprehensive Segmental Revision System may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients undergoing shoulder arthroplasty by confirming the safety and effectiveness of the new tissue attachment device.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in improving surgical outcomes with innovative medical devices.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boca Raton, Florida
- Toman Orthopedics and Sports Med — Boca Raton, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Cayla J LaFollette, BS
- Email: cayla.lafollette@zimmerbiomet.com
- Phone: 574-268-8610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthroplasty Complications, Osteo Arthritis Shoulders, Medical Device, Safety, Performance