Changes in Anthropometry Following Ambulatory Orthopaedic... | NCT02435251

Studies
Changes in Anthropometry Following Ambulatory Orthopaedic Surgery

NCT02435251

Sponsor

State University of New York at Buffalo

Status

Withdrawn

Last Update Posted

Oct 23, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Knee Surgery
Shoulder Surgery

Interventions

dual energy X-ray absorptiometry

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study was no longer feasible

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Apr 27, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2019

Last Update Posted Date

Oct 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leslie Bisson, June A. & Eugene R. Mindell, MD Professor and Chair, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
dual energy X-ray absorptiometry	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fat mass		6-weeks after surgery

Secondary Outcomes

Measure	Description	Time Frame
Lean mass		6-weeks after surgery
Weight		6-weeks after surgery
Body mass index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are scheduled to undergo ambulatory orthopaedic surgery at our institution.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leslie Bisson, MD	University at Buffalo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UBMD Orthopaedics & Sports Medicine		Amherst	New York	14226	United States

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided