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New shoulder implant shows promise in early study

NCT ID NCT04968405

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new shoulder implant called the Catalyst CSR System in 87 people with shoulder arthritis or bone damage. The implant is designed to preserve more natural bone than traditional replacements. Researchers measured pain, movement, and implant safety over two years. The goal was to see if the device performs well and is safe for everyday use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Catalyst CSR Total Shoulder System (a bone-preserving shoulder implant)
What this could lead to
If successful, this implant could offer a less invasive option for shoulder replacement, potentially preserving more bone and improving recovery.
What could go wrong
This is a small, completed study with no control group, so results may not apply to everyone. Implant risks include infection, loosening, or need for revision surgery.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

87 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2026

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 18 years of age or older * Patient must be skeletally mature with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty * Meets the Catalyst CSR Shoulder System Indications for Use according to approved labeling Exclusion Criteria * Has a history of open surgery to index shoulder prior to treatment with the Catalyst CSR system? (history of previous arthroscopic surgery allowed) * Has a full thickness rotator cuff tear diagnosed by MFI or marked posterior glenoid wear * Patient is unwilling or unable to comply with the post-operative care instructions, attend follow visits per the study schedule and complete the study assessments (i.e., Pros) * The patient is a non-English speaker * In the opinion of the investigator, is it not in the patient's best interest to participate in this study * Local or systemic infection, or osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, joint replacement surgery should be delayed until infection is resolved * Inadequate or malformed bone that precludes adequate support of fixation of the prosthesis * Osteoporosis * Neuromuscular disorders that do not allow control of the joint * Chronic instability, chronic dislocation or deficient soft tissues and other support structures (e.g., brachial plexus or deltoid muscles) * Vascular insufficiency * Subject's age, weight or activity level cause the surgeon to expect early failure of the system * The patient is unwilling to comply or unable to comply with the post-operative care instructions * Alcohol, drug, substance abuse or other conditions that would affect or impair the patient from complying with post-operative instructions * Patients with known sensitivity to Co-Cr-Mo alloys typically used prosthetic devices * Any disease that could adversely affect the function or expected longevity of the implants (e.g., metabolic disorders)

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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

  • Beaumont Hospital Royal Oak

    Royal Oak, Michigan, 48073, United States

  • Kaiser Permanente Northwest Center for Health Research

    Portland, Oregon, 97227, United States

  • Lifespan/University Orthopedics

    Providence, Rhode Island, 02914, United States

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