- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617107
Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty (rTSA)
October 23, 2019 updated by: The Orthopaedic Research & Innovation Foundation
The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes.
Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Edgewood, Kentucky, United States, 41017
- The Orthopaedic Research & Innovation Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All eligible patients of principal investigator receiving rTSA for any indication at St. Elizabeth Healthcare between January 1, 2010 and October 31, 2017 will be evaluated and included in the data analysis.
Description
Inclusion Criteria:
- English speaking
- >18 years of age
- Reverse TSA performed by principal investigator
Exclusion Criteria:
- Non-English speaking
- <18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total operative time
Time Frame: preoperative to up to 8 years postoperative
|
minutes
|
preoperative to up to 8 years postoperative
|
amount of blood loss
Time Frame: preoperative to up to 8 years postoperative
|
mls
|
preoperative to up to 8 years postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Outcomes
Time Frame: preoperative to up to 8 years postoperative
|
American Shoulder and Elbow Surgeon score to measure shoulder function and pain.
Scale of 0-100, 100 being the best possible score
|
preoperative to up to 8 years postoperative
|
Patient Outcomes
Time Frame: preoperative to up to 8 years postoperative
|
Simple Shoulder Test score to measure shoulder function.
Scale from 0-12, 12 being the most functional.
|
preoperative to up to 8 years postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: R M Greiwe, MD, The Orthopaedic Research & Innovation Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2017
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
October 25, 2019
Last Update Submitted That Met QC Criteria
October 23, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Fractures, Bone
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Arm Injuries
- Crystal Arthropathies
- Chondrocalcinosis
- Osteoarthritis
- Rotator Cuff Injuries
- Humeral Fractures
- Shoulder Fractures
- Rotator Cuff Tear Arthropathy
Other Study ID Numbers
- ORIF.004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Rotator Cuff Tear
-
Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Keele UniversityUniversity Hospitals, Leicester; Liverpool University Hospitals NHS Foundation... and other collaboratorsWithdrawnTraumatic Rotator Cuff TearUnited Kingdom
-
Rush University Medical CenterSmith & Nephew, Inc.CompletedRotator Cuff Tear Repair Anchors
-
University of MichiganCompletedFull Thickness Rotator Cuff Tear
-
Johannes Kepler University of LinzCompletedFull Thickness Rotator Cuff TearAustria
-
Lawson Health Research InstituteCompleted
-
Orthofix Inc.TerminatedPEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears (RCStim)Full-thickness Rotator Cuff TearUnited States
-
InGeneron, Inc.CompletedRotator Cuff Tear - Partial ThicknessUnited States
-
Izmir Katip Celebi UniversityTerminatedPartial Thickness Rotator Cuff TearTurkey
-
BioMimetic TherapeuticsCompletedFull Thickness Rotator Cuff TearCanada
Clinical Trials on reverse total shoulder arthroplasty
-
Ottawa Hospital Research InstituteRecruiting
-
Washington University School of MedicineZimmer BiometTerminated
-
University of AlbertaCanadian Orthopaedic Foundation; University Hospital FoundationRecruitingShoulder OsteoarthritisCanada
-
Ottawa Hospital Research InstituteRecruitingOsteoarthritis ShoulderCanada
-
Stryker Trauma GmbHTerminatedArthroplasty | Hemiarthroplasty | Shoulder PainUnited States
-
Signe Rosner RasmussenHerlev and Gentofte HospitalNot yet recruiting
-
Bürgerspital SolothurnCompletedReverse Total Shoulder ArthroplastySwitzerland
-
Karolinska InstitutetCompleted
-
Oslo University HospitalDiakonhjemmet Hospital; Sykehuset Telemark; Helse Forde; Sykehuset Ostfold; Sykehuset... and other collaboratorsCompletedProximal Humeral Fractures, AO/OTA (2007) Group B2 and C2Norway
-
I.M. Sechenov First Moscow State Medical UniversityUnknownShoulder Osteoarthritis | Proximal Humeral Fracture | Avascular Necrosis of HumerusRussian Federation