NCT02435251

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

2.2 years

First QC Date

April 27, 2015

Last Update Submit

October 21, 2019

Conditions

Knee SurgeryShoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • Fat mass

    6-weeks after surgery

Secondary Outcomes (3)

  • Lean mass

    6-weeks after surgery

  • Weight

    6-weeks after surgery

  • Body mass index

    6-weeks after surgery

Interventions

dual energy X-ray absorptiometryDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years-old
  • scheduled to undergo knee or shoulder ambulatory surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBMD Orthopaedics & Sports Medicine

Amherst, New York, 14226, United States

Location

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Leslie Bisson, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
June A. & Eugene R. Mindell, MD Professor and Chair

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 6, 2015

Study Start

January 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

US(1)