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Clinical Evaluation of the TITAN™ Total Shoulder System

NCT ID: NCT03245320

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-20

Study Completion Date

2022-06-23

Brief Summary

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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

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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

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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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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TITAN™ Total Shoulder System Generation 1.0

Integra TITAN™ Total Shoulder System Generation 1.0

Integra TITAN™ Total Shoulder Generation 1.0

Intervention Type DEVICE

Total Shoulder Arthroplasty or Hemiarthroplasty

Interventions

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Integra TITAN™ Total Shoulder Generation 1.0

Total Shoulder Arthroplasty or Hemiarthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Tummon

Role: STUDY_DIRECTOR

Integra LifeSciences

Locations

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OrthoIndy

Indianapolis, Indiana, United States

Site Status

The Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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T-TSS-002

Identifier Type: -

Identifier Source: org_study_id