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

NCT03250767 | Terminated FDA Device

• 1 other identifier: T-TSS-003
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 7

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.

Conditions

Osteo Arthritis Shoulders; Traumatic Arthritis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Implant Survivorship

  Implant survivorship defined as absence of device removal or revision

  2 years

Secondary Outcomes (7)

• Implant Survivorship

  1,5 and 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 American Shoulder & Elbow Surgeons Score (ASES) compared to baseline

  up to 10 years

• Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline

  up to 10 years

Study Arms (1)

Integra Titan Modular Shoulder System 2.5

Device: Integra Titan Modular Shoulder System 2.5

Interventions

Integra Titan Modular Shoulder System 2.5 DEVICE

Primary Shoulder Joint Replacement

Integra Titan Modular Shoulder System 2.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with shoulder arthritis requiring primary shoulder joint replacement

You may qualify if:

• 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
• Rotator cuff arthropathy
• Deformity and/or limited motion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0111, United States

Location

John Hopkins University

Columbia, Maryland, 21044, United States

Location

Mississipi Bone and Joint Clinic

Starkville, Mississippi, 39759, United States

Location

The Research Foundation for The State University of New York (SUNY)

Syracuse, New York, 13210, United States

Location

Westphal Orthopaedics

Lancaster, Pennsylvania, 17601, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 16, 2017
• Study Start: August 1, 2017
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

US (7)