Clinical trial NCT03245320: Clinical Evaluation of the TITAN™ Total Shoulder System
Official title: A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant survival at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Implant survival .
timeFrame: 5 and 10 years
measure: Relative change of Range of Motion (ROM) compared to baseline
timeFrame: 2, 5, and 10 years
measure: Radiographic assessment
timeFrame: 2, 5, and 10 years
measure: Relative change in Quality Of Life (EQ-5D) compared to baseline
timeFrame: 2, 5, and 10 years
measure: Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline
timeFrame: 2, 5, and 10 years
measure: Relative change of PENN Pain and Function Score (PENN) compared to baseline
timeFrame: 2, 5, and 10 years
measure: Relative change in Quality Of Life (SF-12V1) compared to baseline
timeFrame: 2, 5, and 10 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
Study officials:
affiliation: Integra LifeSciences
name: Andrew Tummon
role: STUDY_DIRECTOR
References: