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Clinical Evaluation of the TITAN™ Total Shoulder System

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ClinicalTrials.gov Identifier: NCT03245320
Recruitment Status : Active, not recruiting
First Posted : August 10, 2017
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Study Description
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Brief Summary:
A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.

Condition or disease Intervention/treatment
Arthritis Arthritis, Degenerative Rheumatoid Arthritis Post-traumatic Arthrosis of Other Joints, Shoulder Region Rotator Cuff Syndrome of Shoulder and Allied Disorders Fracture Avascular Necrosis Joint Instability Joint Trauma Dislocation, Shoulder Pain, Shoulder Device: Integra TITAN™ Total Shoulder Generation 1.0

Detailed Description:
Observational, multi-center, post-market study to provide data on the performance and safety of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.
Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2028
Groups and Cohorts
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Group/Cohort Intervention/treatment
TITAN™ Total Shoulder System Generation 1.0
Integra TITAN™ Total Shoulder System Generation 1.0
 Device: Integra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty


Outcome Measures
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Primary Outcome Measures :
  1. Implant survival at 2 years [ Time Frame: 2 years ]
    Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).


Secondary Outcome Measures :
  1. Implant survival . [ Time Frame: 5 and 10 years ]
    Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).

  2. Relative change of Range of Motion (ROM) compared to baseline [ Time Frame: 2, 5, and 10 years ]
    Relative change of Range of Motion (ROM) compared to baseline

  3. Radiographic assessment [ Time Frame: 2, 5, and 10 years ]
    Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency

  4. Relative change in Quality Of Life (EQ-5D) compared to baseline [ Time Frame: 2, 5, and 10 years ]
    Relative change in Quality Of Life (EQ-5D) compared to baseline

  5. Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline [ Time Frame: 2, 5, and 10 years ]
    Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline

  6. Relative change of PENN Pain and Function Score (PENN) compared to baseline [ Time Frame: 2, 5, and 10 years ]
    Relative change of PENN Pain and Function Score (PENN) compared to baseline

  7. Relative change in Quality Of Life (SF-12V1) compared to baseline [ Time Frame: 2, 5, and 10 years ]
    Relative change in Quality Of Life (SF-12V1) compared to baseline


Eligibility Criteria
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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
Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
Criteria

Inclusion Criteria:

  1. Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
  2. The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
  3. Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion Criteria:

  1. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
  2. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Contacts and Locations
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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): NCT03245320


Locations
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United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46278
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
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Study Director: Andrew Tummon Integra LifeSciences
More Information
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Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT03245320    
Other Study ID Numbers: T-TSS-002
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 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
Joint Diseases
Osteoarthritis
Joint Instability
Shoulder Pain
Shoulder Dislocation
Necrosis
Musculoskeletal Diseases
 Rheumatic Diseases
Pathologic Processes
Joint Dislocations
Wounds and Injuries
Arthralgia
Pain
Neurologic Manifestations
Shoulder Injuries