Osteoarthritis ShoulderNCT04968405
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
A study testing Catalyst CSR Total Shoulder System in people with Osteoarthritis Shoulder and Avascular Necrosis of the Head of Humerus, run by Catalyst OrthoScience at 3 sites in United States.
Trial summary
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
- What is being tested?
- Catalyst CSR Total Shoulder System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jul 2022to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, 97227
Lifespan/University Orthopedics
Providence, Rhode Island, 02914
Beaumont Hospital Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States.
Read the detailed description
The purpose of this study is to assess the performance and safety of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Patients who sign informed consent and meet the inclusion/exclusion criteria will have the Catalyst CSR Shoulder system implanted at participating sites. Data will be collected at baseline (pre-operative), perioperatively, and postoperatively at 3 months, 6 months, 12 months and 24 months. This study is expected to take 36 months to complete.
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
- Being tested
- Catalyst CSR Total Shoulder System
- Keywords
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Correction of functional deformity
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catalyst CSR Total Shoulder SystemDevice
The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Intervention with a 510k cleared shoulder arthroplasty device Receives: Device: Catalyst CSR Total Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Change from baseline in patient reported outcome scores using the ASES
Measured: 12 Months
Secondary outcomes (7)
Radiographic Assessment
Lack of radiographic evidence of osteolysis, stress shielding or lucent line formation through a minimum of 12-months post operation.
Measured: 3 months, 6 months, 12 months, 24 months
Range of Motion Assessment
Change active range of motion (ROM) from baseline (preoperative)
Measured: Baseline, 3 months, 6 months, 12 months, 24 months
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Change from baseline in patient reported outcome scores using the ASES
Measured: Baseline 3 months, 6 months, 12 months, 24 months
PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire
Change from baseline in patient reported outcome scores using the PROMIS
Measured: Baseline 3 months, 6 months, 12 months, 24 months
Single Assessment Numeric Evaluation (SANE)
Change from baseline in patient reported outcome scores using the SANE
Measured: Baseline 3 months, 6 months, 12 months, 24 months
Visual Analog Score (VAS) Scale
Change from baseline in patient reported outcome scores using the VAS
Measured: Baseline 3 months, 6 months, 12 months, 24 months
Patient Satisfaction Assessment
Patient Satisfaction
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start22 Jul 2022
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Catalyst CSR Shoulder System
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalyst OrthoScience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Michael Wiater, MD, Principal investigator, Beaumont Hospital Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968405
- Sponsor's protocol ID
- 1226-9272-01
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2020
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study
- ClinicalTrials.gov ID
- NCT04968405
- Acronym / sponsor ID
- 1226-9272-01
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
- Keywords
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Correction of functional deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Catalyst OrthoScienceIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States.
Detailed description
The purpose of this study is to assess the performance and safety of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Patients who sign informed consent and meet the inclusion/exclusion criteria will have the Catalyst CSR Shoulder system implanted at participating sites. Data will be collected at baseline (pre-operative), perioperatively, and postoperatively at 3 months, 6 months, 12 months and 24 months. This study is expected to take 36 months to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Catalyst CSR Shoulder System
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Catalyst CSR Total Shoulder SystemIntervention with a 510k cleared shoulder arthroplasty device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catalyst CSR Total Shoulder SystemThe Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. | Device | Single Arm |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Time frame: 12 Months
Change from baseline in patient reported outcome scores using the ASES
7 secondary outcomes
Radiographic Assessment
Time frame: 3 months, 6 months, 12 months, 24 months
Range of Motion Assessment
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Time frame: Baseline 3 months, 6 months, 12 months, 24 months
PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire
Time frame: Baseline 3 months, 6 months, 12 months, 24 months
Single Assessment Numeric Evaluation (SANE)
Time frame: Baseline 3 months, 6 months, 12 months, 24 months
Visual Analog Score (VAS) Scale
Time frame: Baseline 3 months, 6 months, 12 months, 24 months
Patient Satisfaction Assessment
Time frame: 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Michael Wiater, MD principal investigator
Beaumont Hospital Royal Oak
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catalyst CSR Total Shoulder System in people with Osteoarthritis Shoulder and Avascular Necrosis of the Head of Humerus, run by Catalyst OrthoScience at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.