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Trial record 1 of 1 for:    Modular Shoulder System 2.5 for Primary Shoulder Joint Replacement
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Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250767
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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.

Condition or disease Intervention/treatment
Osteo Arthritis Shoulders Traumatic Arthritis Rheumatoid Arthritis Device: Integra Titan Modular Shoulder System 2.5

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : April 1, 2029

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Implant Survivorship [ Time Frame: 2 years ]
    Implant survivorship defined as absence of device removal or revision


Secondary Outcome Measures :
  1. Implant Survivorship [ Time Frame: 1,5 and 10 years ]
    Implant survivorship defined as absence of device removal or revision

  2. Relative change of Range of Motion (ROM) compared to baseline [ Time Frame: up to 10 years ]
    Relative change of ROM compared to baseline

  3. Relative change of Constant-Murley Score (CMS) compared to baseline [ Time Frame: up to 10 years ]
    Relative change of CMS compared to baseline

  4. Relative change of American Shoulder & Elbow Surgeons Score (ASES) compared to baseline [ Time Frame: up to 10 years ]
    Relative change of ASES compared to baseline

  5. Relative change of Single Assessment Numeric Evaluation (SANE) compared to baseline [ Time Frame: up to 10 years ]
    Relative change of SANE compared to baseline

  6. Relative change of Simple Shoulder Test (SST) compared to baseline [ Time Frame: up to 10 years ]
    Relative change of SST compared to baseline

  7. Relative change of Pain compared to baseline [ Time Frame: up to 10 years ]
    Relative change of Visual Analogue Scale (VAS) Pain compared to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with shoulder arthritis requiring primary shoulder joint replacement
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250767


Contacts
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Contact: Andrew Tummon (+1) 609-936-5490 andrew.tummon@integralife.com

Locations
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United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294-0111
United States, Maryland
John Hopkins University Recruiting
Columbia, Maryland, United States, 21044
Contact: Jessica Jang         
United States, Mississippi
Mississipi Bone and Joint Clinic Terminated
Starkville, Mississippi, United States, 39759
United States, New York
The Research Foundation for The State University of New York (SUNY) Recruiting
Syracuse, New York, United States, 13210
Contact: Tina Craig    315-464-8618    CraigT@upstate.edu   
Contact: Carmelita Woods       woodscr@upstate.edu   
Principal Investigator: Kevin Setter, MD         
United States, Pennsylvania
Westphal Orthopaedics Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Edgar Garcia         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Evan Bannister         
The Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Thema Richardson    267-339-3615    thema.nicholson@rothmaninstitute.com   
United States, Virginia
University of Virginia Health System Withdrawn
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Integra LifeSciences Corporation
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Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT03250767    
Other Study ID Numbers: T-TSS-003
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases