Reliability and Diagnostic Accuracy of an Alternate Lachm... | NCT01301014

Studies
Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position

NCT01301014

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

57Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Stability

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Feb 18, 2011

First Submission Date that Met QC Criteria

Feb 18, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2016

Last Update Posted Date

May 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ed Mulligan, Associate Professor, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is investigating the reliability and diagnostic accuracy of a Lachman's test conducted in a prone position to detect the presence of a torn anterior cruciate ligament.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current knee pain complaint in subjects between 15 and 60 years old

Exclusion Criteria:

the inability to assume the prone testing position
evidence of a fracture by application of the Ottawa Fracture rule
previous knee joint arthroplasty
suspicion of posterior cruciate involvement
knee surgery in the previous six months
presence of serious underlying non-mechanical pathology
systemic illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

31 men and 21 women ranging in age from 16-57 years old with complaint of knee pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern Medical Center		Dallas	Texas	76039	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21891874	Derived	Mulligan EP, Harwell JL, Robertson WJ. Reliability and diagnostic accuracy of the Lachman test performed in a prone position. J Orthop Sports Phys Ther. 2011 Oct;41(10):749-57. doi: 10.2519/jospt.2011.3761. Epub 2011 Sep 4.