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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

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

NCT ID

NCT04968405

First Posted

March 11, 2020

Last Updated

January 12, 2023

Sponsor

Catalyst OrthoScience

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

Lauren.Davey@Beaumont.org

First Name & Middle Initial & Last Name & Degree

Shalinee Mylvaganam

Phone

248-551-0194

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

phyllis.a.ramey@kpchr.org

First Name & Middle Initial & Last Name & Degree

Jennifer E. Cook

Phone

506-571-2273

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

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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