Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

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

TERMINATED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2023-03-10

Brief Summary

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A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.

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Detailed Description

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Conditions

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Osteo Arthritis Shoulders Traumatic Arthritis Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Integra Titan Modular Shoulder System 2.5

Intervention Type DEVICE

Primary Shoulder Joint Replacement

Interventions

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Integra Titan Modular Shoulder System 2.5

Primary Shoulder Joint Replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* For total shoulder arthroplasty, subjects must meet a, b, or c below:

1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
* For shoulder hemiarthroplasty, subjects must meet any of the sub-criteria a - g below:

1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
4. Ununited humeral head fractures
5. Avascular necrosis of the humeral head
6. Rotator cuff arthropathy
7. Deformity and/or limited motion

Exclusion Criteria

* Absent, irreparable or nonfunctional rotator cuff or other essential muscles.
* Have an active local or systemic infection.
* Have inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components.
* Have poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
* Have a muscular, neurologic, or vascular deficiencies that compromise the affected extremity.
* Have a known sensitivity or allergic reaction to one or more of the implanted materials.
* Have a condition that may impair proper wound healing.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No