Clinical Evaluation of the TITAN™ Total Shoulder System

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03245320
• Other study ID #: T-TSS-002
• Status: Terminated
• Start date: March 20, 2017
• Est. completion date: June 23, 2022

Study information

• Verified date: December 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 23, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Avascular Necrosis
• Dislocation, Shoulder
• Fracture
• Joint Instability
• Joint Trauma
• Necrosis
• Osteoarthritis
• Pain, Shoulder
• Post-traumatic Arthrosis of Other Joints, Shoulder Region
• Rheumatoid Arthritis
• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Shoulder Dislocation
• Shoulder Pain

Intervention

Device:
• Integra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty

Locations

Country	Name	City	State
United States	OrthoIndy	Indianapolis	Indiana
United States	The Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Radiographic assessment	Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency	2, 5, and 10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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