New shoulder implant under review: will it hold up over time?
NCT ID NCT06615739
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well a special shoulder implant works for people who need a joint replacement due to arthritis, injury, or bone loss. Researchers will track 22 participants to see how long the implant lasts and if there are any problems. The goal is to make sure the implant is safe and helps people move and feel better.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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22 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects must meet the inclusion criteria to be enrolled into the study. Subjects who meet any of the exclusion criteria should not be enrolled into the study. The study population will comprise a consecutive cohort of up to 103 subjects implanted using the Comprehensive SRS Regenerex Tissue Attachment Augments.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Toman Orthopedics and Sports Med
Boca Raton, Florida, 33432, United States
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Other studies related to the condition(s) this trial covers.
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