Traumatic Knee ArthrotomyNCT01073124
Sensitivity Diagnosing Traumatic Knee Injuries With and Without Injection of Blue Dye Into the Knee Joint
A study testing Saline Load Test in people with Traumatic Knee Arthrotomy, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to determine if adding blue dye improves the saline load test, which is a way to detect a traumatic intraarticular knee injury by injecting normal saline into the knee and looking for outflow through the wound. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Knee Arthrotomy
- What is being tested?
- Saline Load Test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Oct 2009
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with diagnosis warranting elective knee arthroscopy
Who cannot join
- Pregnant women
- Decreased knee range of motion (flex < 125, ext <0)
- Active infection of knee joint
- history of or current intraarticular knee malignancy
- history of open traumatic injury of the knee
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Sensitivity of the Saline Load Test With and Without Methylene Blue Dye in the Diagnosis of Traumatic Knee Arthrotomies
The purpose of this study is to determine if adding blue dye improves the saline load test, which is a way to detect a traumatic intraarticular knee injury by injecting normal saline into the knee and looking for outflow through the wound.
- Conditions
- Traumatic Knee Arthrotomy
- Being tested
- Saline Load Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline Load TestProcedure or surgery
Intraarticular injection of dilute methylene blue dye (1 ml per 500 ml normal saline) or normal saline into the knee joint through a lateral suprapatellar injection site. Maximum injection of 180 ml.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | Normal Saline injected intraarticularly into the knee joint Receives: Procedure: Saline Load Test |
| Dilute Methylene Blue Dye | Experimental | 1 ml methylene blue dye per 500 ml normal saline injected intraarticularly into the knee Receives: Procedure: Saline Load Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume (mm) injected at time of outflow
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMay 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Knee ArthrotomyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul D Metzger, MD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073124
- Sponsor's protocol ID
- NMCSD.2008.0006
- Status last verified
- Aug 2016
- First submitted
- 22 Feb 2010
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of the Saline Load Test With and Without Methylene Blue Dye in the Diagnosis of Traumatic Knee Arthrotomies
- ClinicalTrials.gov ID
- NCT01073124
- Acronym / sponsor ID
- NMCSD.2008.0006
- Conditions
- Traumatic Knee Arthrotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- May 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Feb 2010 (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.
The purpose of this study is to determine if adding blue dye improves the saline load test, which is a way to detect a traumatic intraarticular knee injury by injecting normal saline into the knee and looking for outflow through the wound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Procedure: Saline Load TestNormal Saline injected intraarticularly into the knee joint |
| Dilute Methylene Blue Dye | Experimental | Procedure: Saline Load Test1 ml methylene blue dye per 500 ml normal saline injected intraarticularly into the knee |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with diagnosis warranting elective knee arthroscopy
Key exclusion criteria (5 listed)
- Pregnant women
- Decreased knee range of motion (flex < 125, ext <0)
- Active infection of knee joint
- history of or current intraarticular knee malignancy
- history of open traumatic injury of the knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline Load TestIntraarticular injection of dilute methylene blue dye (1 ml per 500 ml normal saline) or normal saline into the knee joint through a lateral suprapatellar injection site. Maximum injection of 180 ml. | Procedure or surgery | Dilute Methylene Blue Dye, Normal Saline |
Primary outcome
Volume (mm) injected at time of outflow
Time frame: 1 month
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 19 Aug 2016.
- Individual participant dataSharing planned: No
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.
Paul D Metzger, MD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Load Test in people with Traumatic Knee Arthrotomy, run by United States Naval Medical Center, San Diego 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 5 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 19 Aug 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.
What does the primary outcome measure?
Volume (mm) injected at time of outflow (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2016.