A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

Smith & Nephew, Inc.7 sites in 1 country58 target enrollmentAugust 1, 2017

ConditionsOsteo Arthritis Shoulders Traumatic Arthritis Rheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteo Arthritis Shoulders
Sponsor: Smith & Nephew, Inc.
Enrollment: 58
Locations: 7
Primary Endpoint: Implant Survivorship
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2017

End Date

March 10, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Smith & Nephew, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For total shoulder arthroplasty, subjects must meet a, b, or c below:
•Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
•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
•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:
•Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
•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
•Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. -revision of a failed primary component)
•Ununited humeral head fractures
•Avascular necrosis of the humeral head

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.

Outcomes

Primary Outcomes

Implant Survivorship

Time Frame: 2 years

Implant survivorship defined as absence of device removal or revision

Secondary Outcomes

Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline(up to 10 years)
Implant Survivorship(1,5 and 10 years)
Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline(up to 10 years)
Relative change of Range of Motion (ROM) compared to baseline(up to 10 years)
Relative change of Constant-Murley Score (CMS) compared to baseline(up to 10 years)
Relative change of Simple Shoulder Test (SST) compared to baseline(up to 10 years)
Relative change of Pain compared to baseline(up to 10 years)