TerminatedNCT03245320Updated Dec 21, 2023

Clinical Evaluation of the TITAN™ Total Shoulder System

An observational study in Arthritis, Arthritis, Degenerative and Rheumatoid Arthritis, sponsored by Smith & Nephew, Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.

Sponsored by Smith & Nephew, Inc. · Observational

Why this study was terminated

Terminated by the Sponsor. Decision not due to adverse events, complications, or device issues.

Study type: Observational
Model: Case-control
Time perspective: Other
Enrollment: 50
Ages: 18 Years and older
Sex: All

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.

Read the 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 studied

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

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-control
Time perspective: Other
Enrollment: 50 participants (actual)
Patient registry: No

Groups and cohorts

TITAN™ Total Shoulder System Generation 1.0
Integra TITAN™ Total Shoulder System Generation 1.0
Device: Integra TITAN™ Total Shoulder Generation 1.0

Interventions

DeviceIntegra TITAN™ Total Shoulder Generation 1.0
Total Shoulder Arthroplasty or Hemiarthroplasty

What researchers measure

Primary outcomes

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).
Time frame: 2 years

Secondary outcomes

Implant survival .
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
Time frame: 5 and 10 years
Relative change of Range of Motion (ROM) compared to baseline
Relative change of Range of Motion (ROM) compared to baseline
Time frame: 2, 5, and 10 years
Radiographic assessment
Radiographic assessment for loosening, malpositioned implant, subsidence, subluxation, and radiolucency
Time frame: 2, 5, and 10 years
Relative change in Quality Of Life (EQ-5D) compared to baseline
Relative change in Quality Of Life (EQ-5D) compared to baseline
Time frame: 2, 5, and 10 years
Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
Time frame: 2, 5, and 10 years
Relative change of PENN Pain and Function Score (PENN) compared to baseline
Relative change of PENN Pain and Function Score (PENN) compared to baseline
Time frame: 2, 5, and 10 years
Relative change in Quality Of Life (SF-12V1) compared to baseline
Relative change in Quality Of Life (SF-12V1) compared to baseline
Time frame: 2, 5, and 10 years

Study locations

2 sites

OrthoIndy
Indianapolis, Indiana 46278, United States
The Rothman Institute
Philadelphia, Pennsylvania 19107, United States

Registry details

Key details

Study ID: NCT03245320
Lead sponsor: Smith & Nephew, Inc.
Responsible party: Sponsor
First posted: Aug 10, 2017
Start date: Mar 20, 2017
Primary completion: Mar 22, 2022
Completion: Jun 23, 2022
Last update: Dec 21, 2023

Study contacts

Andrew Tummon

study director · Integra LifeSciences

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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