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)
Kaplan Meier Implant Survivorship — Up to 10 Years This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival.
Safety Assessement — Up to 10 Years This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified.
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.
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