Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Reverse Shoulder System used in Primary or Revision Total Shoulder Arthroplasty
Previous Study | Return to List | Next Study

TITAN™ Reverse Shoulder System

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204228
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.

Condition or disease Intervention/treatment
Osteoarthritis of the Shoulder Device: TITAN™ Reverse Shoulder System (TRS)

Layout table for study information
Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-market Clinical Follow-up Study of the TITAN™ Reverse Shoulder System Used in Primary or Revision Total Shoulder Arthroplasty
Actual Study Start Date : September 2014
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2033

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TITAN™ Reverse Shoulder System (TRS)
TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.
Device: TITAN™ Reverse Shoulder System (TRS)
All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).




Primary Outcome Measures :
  1. Survival (lack of implant component removal or revision) [ Time Frame: 2 Year ]
    Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.


Secondary Outcome Measures :
  1. Efficacy assessed by comparing clinical results after surgery as measured with American Shoulder and Elbow Surgeons Score (ASES) [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Relative change of ASES compared to baseline

  2. Efficacy assessed by comparing clinical results after surgery as measured with EuroQOL-5 Dimension (EQ-5D) score [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Relative change of EQ-5D score compared to baseline

  3. Efficacy assessed by comparing clinical results after surgery as measured with Range of motion (ROM) [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Relative change of ROM compared to baseline

  4. Efficacy assessed by comparing clinical results after surgery as measured with Constant score. [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Relative change of Constant score compared to baseline

  5. Efficacy assessed by comparing clinical results after surgery as measured with Pain Visual Analog Scale (VAS). [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Relative change of Pain Visual Analog Scale (VAS) compared to baseline

  6. Efficacy assessed by comparing clinical results after surgery as measured with SANE (Single Assessment Numeric Evaluation) [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Relative change of SANE compared to baseline

  7. Efficacy assessed by comparing clinical results after surgery as measured with Radiographs [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Outcome after surgery will be evaluated using the Radiographs and comparison with pre-operative data.

  8. Lack of unanticipated device related serious adverse events. [ Time Frame: 2 Year/5 Year/ 7Year/ 10 Year ]
    Any device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.

  9. Survival (lack of implant component removal or revision) [ Time Frame: 5 Year/7 Year/10 Year ]
    Any implant revisions or device related adverse events must be reported as soon as the event is discovered. Assessment of adverse events will occur at each clinic visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who require reverse shoulder replacement due to the inclusions below.
Criteria

Inclusion Criteria:

  • Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
  • Subjects with a shoulder joint anatomically and structurally suited to receive the device
  • Subjects at least 21 years of age and skeletally mature at the time of surgery
  • Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)

Exclusion Criteria:

  • Subjects without a functional deltoid muscle
  • Subjects with active local or systemic infection
  • Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
  • Subjects with 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
  • Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
  • Subjects with known metal allergies
  • Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
  • Subjects who are prisoners
  • Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods

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): NCT02204228


Locations
Layout table for location information
United States, Florida
University of Florida
Gainesville, Florida, United States, 32607
United States, Maryland
Johns Hopkins University
Columbia, Maryland, United States, 21044
United States, Mississippi
Mississipi Bone and Joint Clinic
Starkville, Mississippi, United States, 39759
United States, New Jersey
Active Orthopedics
Glen Ridge, New Jersey, United States, 07028
United States, Pennsylvania
Westphal Orthopaedics
Lancaster, Pennsylvania, United States, 17601
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
France
Clinique Bizet
Paris, France
Spain
Hospital de Manacor - Llevant
Manacor, Spain, 07500
United Kingdom
Barts Health NHS Trust
London, United Kingdom
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Layout table for investigator information
Study Director: Andrew Tummon Integra LifeSciences
Layout table for additonal information
Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT02204228    
Other Study ID Numbers: CP-0960-001
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: February 2020
Keywords provided by Integra LifeSciences Corporation:
osteoarthritis
rheumatoid arthritis
post traumatic arthritis
avascular necrosis
severe fractures
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases