Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
Primary Purpose
Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Catalyst CSR Total Shoulder System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Shoulder focused on measuring Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Correction of functional deformity
Eligibility Criteria
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)
Sites / Locations
- Beaumont Hospital Royal OakRecruiting
- Kaiser Permanente Northwest Center for Health ResearchRecruiting
- Lifespan/University OrthopedicsRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Intervention with a 510k cleared shoulder arthroplasty device
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Change from baseline in patient reported outcome scores using the ASES
Secondary Outcome Measures
Radiographic Assessment
Lack of radiographic evidence of osteolysis, stress shielding or lucent line formation through a minimum of 12-months post operation.
Range of Motion Assessment
Change active range of motion (ROM) from baseline (preoperative)
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Change from baseline in patient reported outcome scores using the ASES
PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire
Change from baseline in patient reported outcome scores using the PROMIS
Single Assessment Numeric Evaluation (SANE)
Change from baseline in patient reported outcome scores using the SANE
Visual Analog Score (VAS) Scale
Change from baseline in patient reported outcome scores using the VAS
Patient Satisfaction Assessment
Patient Satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04968405
Brief Title
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
Official Title
Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
July 28, 2025 (Anticipated)
Study Completion Date
July 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalyst OrthoScience
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Catalyst CSR Shoulder System
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Intervention with a 510k cleared shoulder arthroplasty device
Intervention Type
Device
Intervention Name(s)
Catalyst CSR Total Shoulder System
Intervention Description
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.
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Description
Change from baseline in patient reported outcome scores using the ASES
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Radiographic Assessment
Description
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
Title
Range of Motion Assessment
Description
Change active range of motion (ROM) from baseline (preoperative)
Time Frame
Baseline, 3 months, 6 months, 12 months, 24 months
Title
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire
Description
Change from baseline in patient reported outcome scores using the ASES
Time Frame
Baseline 3 months, 6 months, 12 months, 24 months
Title
PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire
Description
Change from baseline in patient reported outcome scores using the PROMIS
Time Frame
Baseline 3 months, 6 months, 12 months, 24 months
Title
Single Assessment Numeric Evaluation (SANE)
Description
Change from baseline in patient reported outcome scores using the SANE
Time Frame
Baseline 3 months, 6 months, 12 months, 24 months
Title
Visual Analog Score (VAS) Scale
Description
Change from baseline in patient reported outcome scores using the VAS
Time Frame
Baseline 3 months, 6 months, 12 months, 24 months
Title
Patient Satisfaction Assessment
Description
Patient Satisfaction
Time Frame
6, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
Patient Safety
Description
Report of adverse events/serious adverse event rates related to the procedure or device
Implant removal rate
Revision rate
Time Frame
perioperatively, 3, 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Waite, RN
Phone
3522817747
Email
rwaite@catalystortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Michael Wiater, MD
Organizational Affiliation
Beaumont Hospital Royal Oak
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Davey, RN
Phone
248-551-2313
Email
Lauren.Davey@Beaumont.org
First Name & Middle Initial & Last Name & Degree
Shalinee Mylvaganam
Phone
248-551-0194
Email
Shalinee.mylvaganam@Beaumont.org
First Name & Middle Initial & Last Name & Degree
J. Michael Wiater, MD
Facility Name
Kaiser Permanente Northwest Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Ramey, RN
Phone
503-571-6181
Email
phyllis.a.ramey@kpchr.org
First Name & Middle Initial & Last Name & Degree
Jennifer E. Cook
Phone
506-571-2273
Email
Jennifer.E.Cook@kpchr.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Budge, MD
Facility Name
Lifespan/University Orthopedics
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Portnoff
Phone
401-443-4278
Email
bportnoff@universityorthopedics.com
First Name & Middle Initial & Last Name & Degree
E. Scott Paxton, MD
First Name & Middle Initial & Last Name & Degree
Andrew Green, MD
First Name & Middle Initial & Last Name & Degree
Michel Arcand, MD
12. IPD Sharing Statement
Learn more about this trial
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
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