Clinical trial NCT02047955: Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients
Official title: Tornier Shoulder Outcomes Clinical Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shoulder Arthroplasty and Fracture Repair
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2014-01-29
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from United States and Europe

Brief summary: The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the requirements of the study protocol
* Considered for treatment with one or more Tornier shoulder arthroplasty or fracture devices included in this study

Exclusion Criteria:

* Patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

Primary outcomes:
measure: Number of device associated and procedure associated adverse events
timeFrame: up to 10 years
Secondary outcomes:
measure: Rates of reoperation and revision surgery
timeFrame: up to 10 years
Other outcomes:
measure: Time to first revision surgery
timeFrame: up to 10 years
measure: Change from baseline and previous visit in ASES scores
timeFrame: at 1, 2, 5, 7, and 10 years of follow-up
measure: Constant Score
timeFrame: at 1, 2, 5, 7, and 10 years of follow-up
measure: Change from baseline and previous visit in SANE scores
timeFrame: at 1, 2, 5, 7, 10, 15, and 20 years follow-up
measure: Subject Satisfaction
timeFrame: at 1, 2, 5, 7, and 10 years of follow-up
measure: Cumulative incidence of migration, radiolucency, osteolysis, and bone wear
timeFrame: at 1, 2, 5, 7, and 10 years of follow-up
measure: EQ-5D-5L
timeFrame: at 1, 2, 5, 7, and 10 years of follow-up
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: California Pacific Orthopaedics
state: California
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Atlanta
country: United States
facility: Resurgens Orthopaedics
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Sports Medicine Clinic
state: Iowa
city: Lexington
country: United States
facility: Lexington Clinic Orthopedics - Sports Medicine Center
state: Kentucky
city: Traverse City
country: United States
facility: Great Lakes Orthopaedic Center
state: Michigan
city: Edina
country: United States
facility: Allina Health Orthopedics
state: Minnesota
city: Columbia
country: United States
facility: University of MO - Columbia
state: Missouri
city: Jersey City
country: United States
facility: Jersey Medical Center
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Rothman Institute Orthopaedics
state: Pennsylvania
city: Austin
country: United States
facility: Ascension Medical Group Seton Orthopedics
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Fondren Orthopedic Group
state: Texas
Study officials:
affiliation: Stryker Trauma & Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: