🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06615739
Active, not recruiting Observational

Comprehensive SRS Regenerex Tissue Attachment

NCT06615739 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2024-10-22
Last updated
2025-10-29

Condition(s) studied

Arthroplasty ComplicationsOsteo Arthritis Shoulders

Investigational drug(s) / intervention(s)

Regenerex Tissue Attachment Augments

Regenerex Tissue Attachment Augments: Patient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System

Study summary

The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Toman Orthopedics and Sports Med Boca Raton Florida

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06615739 on ClinicalTrials.gov ↗ ← All trials in the USA