Clinical Evaluation of the TITAN™ Total Shoulder System

Sponsor

Smith & Nephew, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03245320

Collaborator

(none)

Enrollment

Locations

134.4

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	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 Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Mar 20, 2017

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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).
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
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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
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.
Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion Criteria:

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.
Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.