Knee AspirationNCT00888368
Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis
A study testing Transpatellar Approach and Suprapatellar in people with Knee Aspiration, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
The purpose of this study is: To determine the accuracy of intraarticular placement with the transpatellar tendon approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy will be consented for study of the injection of the fluid into the joint prior to portal placement or commencement… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Aspiration
- What is being tested?
- Transpatellar Approach and Suprapatellar
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective arthroscopic surgery of the knee
- age greater than 18 years old and less than 80 years old
- able to consent to a research study
Who cannot join
- allergy to contrast dye, iodine or shellfish
- currently pregnant
- acute fracture or dislocation
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
The purpose of this study is:
- To determine the accuracy of intraarticular placement with the transpatellar tendon approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy will be consented for study of the injection of the fluid into the joint prior to portal placement or commencement of knee replacement. Patients will be randomized to receive injections via the transpatellar tendon or superolateral approach. Using injectable contrast and fluoroscopy, the placement of injections into the knee will be evaluated for accuracy. Injection attempts with contrast fluid that uniformly coats the articular surface on sagittal and coronal radiographs will be counted as successful. A concentration of contrast fluid in extraarticular fat will be counted as a failure.
Read more
Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the transpatellar tendon approach to knee aspiration is greater than that of the superolateral approach.
- To determine the distribution of contrast material with the transpatellar tendon and superolateral apporaches. Using a previously described evaluation technique of dividing the knee into seven compartments, sagittal and coronal fluoroscopy images will be evaluated to determine the distribution of contrast fluid.
Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will penetrate as many compartments of the knee as contrast injected via the superolateral approach.
- Conditions
- Knee Aspiration
- Being tested
- Transpatellar Approach, Suprapatellar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpatellar ApproachProcedure or surgery
The transpateller approach for the injection of the dye will be used.
SuprapatellarProcedure or surgery
The suprapatellar approach will be used for the injection of the dye.
| Study group | Role | What they receive |
|---|---|---|
| Transpatellar Approach | Experimental | Not described Receives: Procedure: Transpatellar Approach |
| Suprapatellar Approach | Active comparator | Not described Receives: Procedure: Suprapatellar |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of an easier approach to aspirating the knee may lead to improved accuracy of intraarticular needle placement by less experienced practitioners and more "anatomically difficult" knees.
Measured: 1 time (intraop)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee AspirationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888368
- Sponsor's protocol ID
- DHMC07-0387
- Status last verified
- Jul 2012
- First submitted
- 23 Apr 2009
- Last updated
- 13 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis
- ClinicalTrials.gov ID
- NCT00888368
- Acronym / sponsor ID
- DHMC07-0387
- Conditions
- Knee Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Apr 2009 (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 the accuracy of intraarticular placement with the transpatellar tendon approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy will be consented for study of the injection of the fluid into the joint prior to portal placement or commencement of knee replacement. Patients will be randomized to receive injections via the transpatellar tendon or superolateral approach. Using injectable contrast and fluoroscopy, the placement of injections into the knee will be evaluated for accuracy. Injection attempts with contrast fluid that uniformly coats the articular surface on sagittal and coronal radiographs will be counted as successful. A concentration of contrast fluid in extraarticular fat will be counted as a failure.
Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the transpatellar tendon approach to knee aspiration is greater than that of the superolateral approach.
- To determine the distribution of contrast material with the transpatellar tendon and superolateral apporaches. Using a previously described evaluation technique of dividing the knee into seven compartments, sagittal and coronal fluoroscopy images will be evaluated to determine the distribution of contrast fluid.
Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will penetrate as many compartments of the knee as contrast injected via the superolateral approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpatellar Approach | Experimental | Procedure: Transpatellar Approach |
| Suprapatellar Approach | Active comparator | Procedure: Suprapatellar |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing elective arthroscopic surgery of the knee
- age greater than 18 years old and less than 80 years old
- able to consent to a research study
Key exclusion criteria (3 listed)
- allergy to contrast dye, iodine or shellfish
- currently pregnant
- acute fracture or dislocation
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 |
|---|---|---|
| Transpatellar ApproachThe transpateller approach for the injection of the dye will be used. | Procedure or surgery | Transpatellar Approach |
| SuprapatellarThe suprapatellar approach will be used for the injection of the dye. | Procedure or surgery | Suprapatellar Approach |
Primary outcome
The development of an easier approach to aspirating the knee may lead to improved accuracy of intraarticular needle placement by less experienced practitioners and more "anatomically difficult" knees.
Time frame: 1 time (intraop)
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 13 Jul 2012.
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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?
A study testing Transpatellar Approach and Suprapatellar in people with Knee Aspiration, run by Denver Health and Hospital Authority 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 3 inclusion and 3 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 13 Jul 2012. 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?
The development of an easier approach to aspirating the knee may lead to improved accuracy of intraarticular needle placement by less experienced practitioners and more "anatomically difficult" knees. (time frame: 1 time (intraop)). 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 13 Jul 2012.