Anterior Cruciate Ligament StabilityNCT01301014
Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position
An observational study of Anterior Cruciate Ligament Stability, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Stability
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 31 men and 21 women ranging in age from 16-57 years old with complaint of knee pain
Who may be able to join
- current knee pain complaint in subjects between 15 and 60 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anterior Cruciate Ligament Stability
- Keywords
- accuracy, anterior cruciate ligament, diagnostic value, examination, knee, Lachman test, sensitivity, specificity
- Medical subject headings
- Hypersensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament StabilityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ed Mulligan, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301014
- Sponsor's protocol ID
- ProneLachman1
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21891874
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position
- ClinicalTrials.gov ID
- NCT01301014
- Acronym / sponsor ID
- ProneLachman1
- Conditions
- Anterior Cruciate Ligament Stability
- Keywords
- accuracy, anterior cruciate ligament, diagnostic value, examination, knee, Lachman test, sensitivity, specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 31 men and 21 women ranging in age from 16-57 years old with complaint of knee pain
Key inclusion criteria (1 listed)
- current knee pain complaint in subjects between 15 and 60 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Derived from this study: PubMed 21891874Mulligan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Stability, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01301014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.