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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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.
Beaumont Hospital Royal Oak
Royal Oak, Michigan, United States
RECRUITINGKaiser Permanente Northwest Center for Health Research
Portland, Oregon, United States
RECRUITINGLifespan/University Orthopedics
Providence, Rhode Island, United States
RECRUITINGAmerican Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Change from baseline in patient reported outcome scores using the ASES
Time frame: 12 Months
Radiographic Assessment
Lack of radiographic evidence of osteolysis, stress shielding or lucent line formation through a minimum of 12-months post operation.
Time frame: 3 months, 6 months, 12 months, 24 months
Range of Motion Assessment
Change active range of motion (ROM) from baseline (preoperative)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline 3 months, 6 months, 12 months, 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient Satisfaction Assessment
Patient Satisfaction
Time frame: 6, 12 and 24 months