Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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

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Osteoarthritis Shoulder Avascular Necrosis of the Head of Humerus Rheumatoid Arthritis Shoulder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Catalyst CSR Shoulder System

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Intervention with a 510k cleared shoulder arthroplasty device

Group Type OTHER

Catalyst CSR Total Shoulder System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes