Clinical Evaluation of the TITAN™ Total Shoulder System

Smith & Nephew

Status: Terminated

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

Treatments: Device: Integra TITAN™ Total Shoulder Generation 1.0

Study type: Observational

Funder types: Industry

Identifiers

NCT03245320

T-TSS-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

TITAN™ Total Shoulder System Generation 1.0

Description:

Integra TITAN™ Total Shoulder System Generation 1.0

Treatment:

Device: Integra TITAN™ Total Shoulder Generation 1.0