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Clinical Evaluation of the TITAN™ Total Shoulder System

NCT03245320 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-12-21

No results posted yet for this study

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

Interventions

DEVICE

Integra TITAN™ Total Shoulder Generation 1.0

Total Shoulder Arthroplasty or Hemiarthroplasty

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrew Tummon · Integra LifeSciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2022-03-22
Completion
2022-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03245320 on ClinicalTrials.gov