NCT02807571

Brief Summary

This study is aimed at determining if office based surgery is an effective way of cutting health care cost while maintaining patient safety and satisfaction.

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 Feb 2017

Shorter than P25 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withdrawn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

First Submitted

Initial submission to the registry

June 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 10, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

June 14, 2016

Last Update Submit

September 21, 2023

Conditions

Surgery

Keywords

Hand

Outcome Measures

Primary Outcomes (1)

  • Complication Rates

    Collect the incidence of complications.

    2 months

Secondary Outcomes (1)

  • Cost savings

    2 months

Interventions

Wide Awake Local Anesthesia No TourniquetPROCEDURE

Wide Awake Local Anesthesia No Tourniquet for office based hand surgery.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015.

You may qualify if:

  • Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015

You may not qualify if:

  • K-wire hardware removal
  • Closed reductions
  • Patients receiving antibiotics at the time of the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Study Officials

  • Peter Jebson, MD

    Corewell Health West

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 21, 2016

Study Start

February 10, 2017

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)