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

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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Traumatic Arthritis; Osteo Arthritis Shoulders
• Intervention / Treatment: Device: Integra Titan Modular Shoulder System 2.5

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0111
      • University of Alabama at Birmingham
  • Maryland
    • Columbia, Maryland, United States, 21044
      • John Hopkins University
  • Mississippi
    • Starkville, Mississippi, United States, 39759
      • Mississipi Bone and Joint Clinic
  • New York
    • Syracuse, New York, United States, 13210
      • The Research Foundation for The State University of New York (SUNY)
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Westphal Orthopaedics
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with shoulder arthritis requiring primary shoulder joint replacement

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Integra Titan Modular Shoulder System 2.5	Device: Integra Titan Modular Shoulder System 2.5; Primary Shoulder Joint Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survivorship	Implant survivorship defined as absence of device removal or revision	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: T-TSS-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes