NCT02969005

Brief Summary

Localization of small femur lesions for resection can be challenging and may be associated with the need for significant fluoroscopic imaging and tissue dissection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

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, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

5 years

First QC Date

October 24, 2016

Last Update Submit

November 23, 2016

Conditions

Bone Diseases

Keywords

radiopaque localizer gridmethylene bluereduce radiation exposure

Outcome Measures

Primary Outcomes (1)

  • The times of C-arm fluoroscopy used

    intraoperative

Secondary Outcomes (1)

  • incision length

    intraoperative

Study Arms (1)

surgery group

EXPERIMENTAL

The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected.

Radiation: surgical treatment

Interventions

surgical treatmentRADIATION

Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions

surgery group

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients with lesions \<20.0 mm

You may not qualify if:

  • patients with lesions \>20.0 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 21, 2016

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share