New shoulder implant shows promise in early study
NCT ID NCT04968405
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
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87 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Feb 2026
- 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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * 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
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Beaumont Hospital Royal Oak
Royal Oak, Michigan, 48073, United States
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Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, 97227, United States
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Lifespan/University Orthopedics
Providence, Rhode Island, 02914, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New nerve block combo may prevent breathing problems during shoulder surgery
- New shoulder implant tracked for 10 years in 300 patients
- 600 patients to test new shoulder implants in Real-World study
- New shoulder implant tested for long-term relief in severe tears and arthritis