NCT03245320

Clinical Evaluation of the TITAN™ Total Shoulder System

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DEVICE	Integra TITAN™ Total Shoulder Generation 1.0	Total Shoulder Arthroplasty or Hemiarthroplasty

Timeline

• Start date: 2017-03-20
• Primary completion: 2022-03-22
• Completion: 2022-06-23
• First posted: 2017-08-10
• Last updated: 2023-12-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study