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

Terminated

• Conditions: Osteo Arthritis Shoulders; Traumatic Arthritis; Rheumatoid Arthritis
• Interventions: Device: Integra Titan Modular Shoulder System 2.5

• Registration Number: NCT03250767
• Lead Sponsor: Smith & Nephew, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integra Titan Modular Shoulder System 2.5	Integra Titan Modular Shoulder System 2.5	-

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	2 years	Implant survivorship defined as absence of device removal or revision

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Westphal Orthopaedics; 🇺🇸 Lancaster, Pennsylvania, United States

Mississipi Bone and Joint Clinic; 🇺🇸 Starkville, Mississippi, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

John Hopkins University; 🇺🇸 Columbia, Maryland, United States

The Research Foundation for The State University of New York (SUNY); 🇺🇸 Syracuse, New York, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

The Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States