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Clinical Evaluation of the TITAN™ Total 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: NCT03245320
Recruitment Status : Active, not recruiting
First Posted : August 10, 2017
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Tracking Information
First Submitted Date May 3, 2017
First Posted Date August 10, 2017
Last Update Posted Date February 9, 2022
Actual Study Start Date March 20, 2017
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2017)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 7, 2017)
  • 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).
  • 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
  • Radiographic assessment [ Time Frame: 2, 5, and 10 years ]
    Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of the TITAN™ Total Shoulder System
Official Title A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
Condition
  • 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
Intervention Device: Integra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty
Study Groups/Cohorts TITAN™ Total Shoulder System Generation 1.0
Integra TITAN™ Total Shoulder System Generation 1.0
Intervention: Device: Integra TITAN™ Total Shoulder Generation 1.0
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 7, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2028
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03245320
Other Study ID Numbers T-TSS-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement Not Provided
Current Responsible Party Smith & Nephew, Inc.
Original Responsible Party Integra LifeSciences Corporation
Current Study Sponsor Smith & Nephew, Inc.
Original Study Sponsor Integra LifeSciences Corporation
Collaborators Not Provided
Investigators
Study Director: Andrew Tummon Integra LifeSciences
PRS Account Smith & Nephew, Inc.
Verification Date February 2022