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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04968405
Other study ID # 1226-9272-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 22, 2022
Est. completion date July 28, 2025

Study information

Verified date November 2023
Source Catalyst OrthoScience
Contact Robin Waite, RN
Phone 3522817747
Email rwaite@catalystortho.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 28, 2025
Est. primary completion date July 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Catalyst CSR Total Shoulder System
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.

Locations

Country Name City State
United States Kaiser Permanente Northwest Center for Health Research Portland Oregon
United States Lifespan/University Orthopedics Providence Rhode Island
United States Beaumont Hospital Royal Oak Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
Catalyst OrthoScience

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient Safety Report of adverse events/serious adverse event rates related to the procedure or device
Implant removal rate
Revision rate
perioperatively, 3, 6, 12 and 24 months
Primary American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire Change from baseline in patient reported outcome scores using the ASES 12 Months
Secondary Radiographic Assessment Lack of radiographic evidence of osteolysis, stress shielding or lucent line formation through a minimum of 12-months post operation. 3 months, 6 months, 12 months, 24 months
Secondary Range of Motion Assessment Change active range of motion (ROM) from baseline (preoperative) Baseline, 3 months, 6 months, 12 months, 24 months
Secondary American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire Change from baseline in patient reported outcome scores using the ASES Baseline 3 months, 6 months, 12 months, 24 months
Secondary PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire Change from baseline in patient reported outcome scores using the PROMIS Baseline 3 months, 6 months, 12 months, 24 months
Secondary Single Assessment Numeric Evaluation (SANE) Change from baseline in patient reported outcome scores using the SANE Baseline 3 months, 6 months, 12 months, 24 months
Secondary Visual Analog Score (VAS) Scale Change from baseline in patient reported outcome scores using the VAS Baseline 3 months, 6 months, 12 months, 24 months
Secondary Patient Satisfaction Assessment Patient Satisfaction 6, 12 and 24 months
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