NCT02023476

Brief Summary

Nerve injury is a serious potential complication associated with the clinical use of exsanguinating tourniquets in surgery. Recently, a novel narrow tourniquet has been proposed, with the claim that it may cause less compression of the nerves. We performed an in vivo comparison of a standard wide tourniquet with the new, narrow tourniquet. Our study specifically looked at neurologic markers in the upper extremity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

December 17, 2013

Last Update Submit

January 9, 2014

Conditions

Nerve Compression

Outcome Measures

Primary Outcomes (1)

  • Nerve compression

    mg/mm2

    20 Minutes

Secondary Outcomes (1)

  • Nerve compression

    20 minutes

Study Arms (2)

wide tourniquet

EXPERIMENTAL

(Zimmer A.T.S.®3000 ) wide tourniquet MRI intervention

Radiation: MRI

narrow tourniquet

ACTIVE COMPARATOR

HemaClear ™ tourniquet MRI intervention

Radiation: MRI

Interventions

MRIRADIATION

MRI- imaging on the upper arm

narrow tourniquetwide tourniquet

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • self defined Caucasian
  • clinically healthy
  • BMI of ≤ 30,
  • a systolic arterial blood pressure ≤190 mmHg,
  • no rash or dermatologic condition or tattoos which may interfere with the placement site
  • no neurovascular impairment.
  • all female participants received a pregnancy test at the initial screening visit.
  • Study population was restricted to Caucasians to enable an assessment of device caused redness or skin lesions, not possible in a mixed study population.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RIAO, Sinai Hospital Baltimore

Baltimore, Maryland, 21215-5271, United States

Location

MeSH Terms

Conditions

Neuroma

Condition Hierarchy (Ancestors)

Nerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Florian M Kovar, MD

    MUW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Lektor Dr. med. univ

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 30, 2013

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)