- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956316
Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Total shoulder arthroplasty using the Titan Modular Total Shoulder System
Exclusion Criteria:
- Declining to participate
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASES
Time Frame: two year post op
|
1. ASES: the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment
i. The ASES consists of two dimensions: pain and function (worth 50 points each). a. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. Patient questions focus on: joint pain, instability and activities of daily living. Physician questions focus on: range of motion, strength, signs and instability |
two year post op
|
EQ-5D-5L
Time Frame: two year post op
|
2. EQ5D-5L: EuroQuol-5D a. The EQ5D-5L scale evaluates general health status. The EQ-5D-5L has two sections; the first section measures health status using a descriptive system (index of 5 scores) and the second section measures health status on a Visual Analog Scale. i. The EQ-5D-5L VAS outcome is measured on a 0 - 100 point scale. Optimal health status is indicated with a score of 100. ii. The EQ-5D-5L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is evaluated with a score of 1-5, higher scores indicate worse outcomes. 1. On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension. |
two year post op
|
PENN
Time Frame: two year post op
|
3. PENN: PENN Shoulder Score
|
two year post op
|
SANE
Time Frame: two year post op
|
4. SANE: Single assessment numeric evaluation
|
two year post op
|
CS
Time Frame: two year post op
|
5. CS: Constant-Murley Score
|
two year post op
|
WOOS
Time Frame: two year post op
|
6. WOOS: Western Ontario Osteoarthritis of the Shoulder index
i. WOOS is composed of 19 items scored on 100-point VAS scales. The 19 items represent four domains (6 questions for pain and physical symptoms, 5 questions for sport/recreation/work function, 5 questions for lifestyle function and 3 questions for emotional function). |
two year post op
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Integra TSA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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