Clinical Evaluation of the TITAN™ Total Shoulder System

NCT03245320 | Terminated FDA Device

• 1 other identifier: T-TSS-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Implant survival .

  5 and 10 years

• Relative change of Range of Motion (ROM) compared to baseline

  2, 5, and 10 years

• Radiographic assessment

  2, 5, and 10 years

• Relative change in Quality Of Life (EQ-5D) compared to baseline

  2, 5, and 10 years

• Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline

  2, 5, and 10 years

Study Arms (1)

TITAN™ Total Shoulder System Generation 1.0

Integra TITAN™ Total Shoulder System Generation 1.0

Device: Integra TITAN™ Total Shoulder Generation 1.0

Interventions

Integra TITAN™ Total Shoulder Generation 1.0 DEVICE

Total Shoulder Arthroplasty or Hemiarthroplasty

TITAN™ Total Shoulder System Generation 1.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

OrthoIndy

Indianapolis, Indiana, 46278, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Fractures, Bone; Osteonecrosis; Joint Instability; Shoulder Dislocation; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Wounds and Injuries; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Shoulder Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Andrew Tummon

  Integra LifeSciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: August 10, 2017
• Study Start: March 20, 2017
• Primary Completion: March 22, 2022
• Study Completion: June 23, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

US (2)