Clinical Evaluation of the TITAN™ Total Shoulder System

A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System

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.

Study Overview

• Status: Terminated
• Conditions: Arthritis; Rheumatoid Arthritis; Avascular Necrosis; Joint Instability; Fracture; Pain, Shoulder; Arthritis, Degenerative; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Joint Trauma; Dislocation, Shoulder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46278
      • OrthoIndy
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • The Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival at 2 years	Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival .	Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).	5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline	Relative change of Range of Motion (ROM) compared to baseline	2, 5, and 10 years
Radiographic assessment	Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency	2, 5, and 10 years
Relative change in Quality Of Life (EQ-5D) compared to baseline	Relative change in Quality Of Life (EQ-5D) compared to baseline	2, 5, and 10 years
Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline	Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline	2, 5, and 10 years
Relative change of PENN Pain and Function Score (PENN) compared to baseline	Relative change of PENN Pain and Function Score (PENN) compared to baseline	2, 5, and 10 years
Relative change in Quality Of Life (SF-12V1) compared to baseline	Relative change in Quality Of Life (SF-12V1) compared to baseline	2, 5, and 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Andrew Tummon, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Shoulder Injuries; Arthralgia; Joint Dislocations; Arthritis; Osteoarthritis; Shoulder Pain; Necrosis; Joint Instability; Shoulder Dislocation
• Other Study ID Numbers: T-TSS-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes