NCT03250767

Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for primary shoulder arthroplasty.

Conditions

• Osteo Arthritis Shoulders
• Traumatic Arthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Integra Titan Modular Shoulder System 2.5	Primary Shoulder Joint Replacement

Timeline

• Start date: 2017-08-01
• Primary completion: 2023-03-10
• Completion: 2023-03-10
• First posted: 2017-08-16
• Last updated: 2023-11-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study