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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03250767
• Other study ID #: T-TSS-003
• Status: Terminated
• Start date: August 1, 2017
• Est. completion date: March 10, 2023

Study information

• Verified date: November 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Osteo Arthritis Shoulders
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• Integra Titan Modular Shoulder System 2.5
Primary Shoulder Joint Replacement

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	John Hopkins University	Columbia	Maryland
United States	Westphal Orthopaedics	Lancaster	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Rothman Institute	Philadelphia	Pennsylvania
United States	Mississipi Bone and Joint Clinic	Starkville	Mississippi
United States	The Research Foundation for The State University of New York (SUNY)	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship	Implant survivorship defined as absence of device removal or revision	2 years
Secondary	Implant Survivorship	Implant survivorship defined as absence of device removal or revision	1,5 and 10 years
Secondary	Relative change of Range of Motion (ROM) compared to baseline	Relative change of ROM compared to baseline	up to 10 years
Secondary	Relative change of Constant-Murley Score (CMS) compared to baseline	Relative change of CMS compared to baseline	up to 10 years
Secondary	Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline	Relative change of ASES compared to baseline	up to 10 years
Secondary	Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline	Relative change of SANE compared to baseline	up to 10 years
Secondary	Relative change of Simple Shoulder Test (SST) compared to baseline	Relative change of SST compared to baseline	up to 10 years
Secondary	Relative change of Pain compared to baseline	Relative change of Visual Analogue Scale (VAS) Pain compared to baseline	up to 10 years