NCT01183078

Brief Summary

Hypothesis: Utilization of the "wand" method will enhance improvements in drill placement, locking nail placement during tibia and femur fracture repairs, and offer less radiation exposure and less operative time. The purpose of this research study is to compare the efficacy of distal locking of intramedullary nails using a standard free-hand technique with the guided wand technique. Distal locking is the placement of screws through the intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays in order to find the holes in the intramedullary rod to place the screws. The wand technique uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of the wand technique could result in improvements in drill placement and locking nail placement as well as decrease operative time and radiation exposure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 16, 2023

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

August 11, 2010

Last Update Submit

May 15, 2023

Conditions

Tibial FracturesFemoral Fractures

Keywords

efficacydrill placementnail placementradiationOperative timeReduction in exposure to radiationAccuracy for nail placement

Outcome Measures

Primary Outcomes (4)

  • Reduced operative time.

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduces operative time.

    Six months post surgery

  • Reduced C-arm exposure

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces C-arm exposure.

    Six months post surgery

  • Reduces inadvertent nail misses.

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces inadvertent "nail misses."

    Six months post surgery

  • No complications

    The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement. It is expected that there will exist no complications related to the use of this technique.

    Six months post surgery

Study Arms (2)

Free-hand technique

OTHER

Free-hand technique utilized to find screw holes.

Procedure: free-hand

Wand technique

OTHER

Wand technique is utilized to find screw holes.

Procedure: Wand technique

Interventions

free-handPROCEDURE

Free-hand technique utilizes x-rays to find screw holes.

Free-hand technique
Wand techniquePROCEDURE

Wand technique is utilized to find screw holes.

Wand technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older with tibial or femoral fracture suitable for operative repair with intramedullary nailing.

You may not qualify if:

  • Fractures requiring repair by retrograde intramedullary nails and interlocking nails.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences - CompRehab

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Tibial FracturesFemoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Riyaz H. Jinnah, MD, FRCS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Eben A. Carroll, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 17, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 16, 2023

Record last verified: 2018-07

Locations

US(1)