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New shoulder implant under review: will it hold up over time?

NCT ID NCT06615739

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

22 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Toman Orthopedics and Sports Med

    Boca Raton, Florida, 33432, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.