- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02435251
Changes in Anthropometry Following Ambulatory Orthopaedic Surgery (CAS)
October 21, 2019 updated by: Leslie Bisson, State University of New York at Buffalo
The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
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
-
-
New York
-
Amherst, New York, United States, 14226
- UBMD Orthopaedics & Sports Medicine
-
-
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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who are scheduled to undergo ambulatory orthopaedic surgery at our institution.
Description
Inclusion Criteria:
- 18-70 years-old
- scheduled to undergo knee or shoulder ambulatory surgery
Exclusion Criteria:
- weighs greater than 350 pounds
- pregnancy
- history of bariatric surgery
- dieting or engaged in a weight loss program
- taking weight loss supplements
- undergoing other types of surgery during study period
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 |
Time Frame |
---|---|
Fat mass
Time Frame: 6-weeks after surgery
|
6-weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lean mass
Time Frame: 6-weeks after surgery
|
6-weeks after surgery
|
Weight
Time Frame: 6-weeks after surgery
|
6-weeks after surgery
|
Body mass index
Time Frame: 6-weeks after surgery
|
6-weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leslie Bisson, MD, University at Buffalo
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
January 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
April 27, 2015
First Submitted That Met QC Criteria
April 30, 2015
First Posted (Estimate)
May 6, 2015
Study Record Updates
Last Update Posted (Actual)
October 23, 2019
Last Update Submitted That Met QC Criteria
October 21, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 458943-7
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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