Clinical Evaluation of the TITAN™ Total Shoulder System

Terminated

• Conditions: Joint Instability; Dislocation, Shoulder; Pain, Shoulder; Rheumatoid Arthritis; Fracture; Avascular Necrosis; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Arthritis; Arthritis, Degenerative; Post-traumatic Arthrosis of Other Joints, Shoulder Region
• Interventions: Device: Integra TITAN™ Total Shoulder Generation 1.0

• Registration Number: NCT03245320
• Lead Sponsor: Smith & Nephew, Inc.

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 Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Primary Completion: 2022-03-22
• Study Completion: 2022-06-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TITAN™ Total Shoulder System Generation 1.0	Integra TITAN™ Total Shoulder Generation 1.0	Integra TITAN™ Total Shoulder System Generation 1.0

Primary Outcome Measures

Name	Time	Method
Implant survival at 2 years	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

Name	Time	Method
Implant survival .	5 and 10 years	Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
Radiographic assessment	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	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	2, 5, and 10 years	Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
Relative change of Range of Motion (ROM) compared to baseline	2, 5, and 10 years	Relative change of Range of Motion (ROM) compared to baseline
Relative change in Quality Of Life (SF-12V1) compared to baseline	2, 5, and 10 years	Relative change in Quality Of Life (SF-12V1) compared to baseline
Relative change of PENN Pain and Function Score (PENN) compared to baseline	2, 5, and 10 years	Relative change of PENN Pain and Function Score (PENN) compared to baseline

Trial Locations

Locations (2)

OrthoIndy; 🇺🇸 Indianapolis, Indiana, United States

The Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States