Arthropathy of KneePhase 4NCT02330185

Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia

A Phase 4 study testing ultrasonography in people with Arthropathy of Knee, run by Diskapi Yildirim Beyazit Education and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The most used anatomical landmark for application of spinal anesthesia is Tuffier's line. Other alternative landmark is tenth rib. However there is no trial that compare these landmarks based on using ultrasonography. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Arthropathy of Knee
What is being tested?: ultrasonography
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Jan 2015to Feb 2015
Phase: Phase 4
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

knee arthroscopic surgery

Who cannot join

BMI>30
anatomical anomaly of vertebrae

About this study

Official title: Phase IV Study of Landmarks for Spinal Anesthesia

Read the detailed description

The investigators aim to compare two landmarks (Tuffier's line and tenth rib line) for accuracy by using ultrasonography. 40 patients will be included in each groups. all of them will be assessed by ultrasonography during application of spinal anesthesia. And the investigators will examine the percentage of successful estimation of correct vertebral space.

Conditions: Arthropathy of Knee
Being tested: ultrasonography
Keywords: spinal anesthesia, ultrasonography, anatomical landmark

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ultrasonographyDevice
spinal anesthesia guided with ultrasonography

Study groups in NCT02330185
Study group	Role	What they receive
spinal anesthesia for knee arthroscopy	Experimental	The intervention is spinal anesthesia. Tenth rib line or Tuffier's line will be examined as application landmarks by ultrasonography for spinal anesthesia. Receives: Device: ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

success of estimation the correct vertebral space
Independently, first anesthesist will determine the spinal anesthesia application point (intervertebral space) according to Tuffier's line and second anesthesist will determine it by ultrasonography. And third anesthesist will compare the accuracy of first determination.
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Feb 2015

First posted1 Jan 2015 (estimated)
Study startJan 2015
Primary completionFeb 2015
Study completionFeb 2015

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 Arthropathy of KneeStudies 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 4
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330185
Sponsor's protocol ID: SALANDMARKUSG
Status last verified: Aug 2015
First submitted: 6 Nov 2014
Last updated: 5 Aug 2015
Results posted: No
Data monitoring committee: No

Publications

Jung CW, Bahk JH, Lee JH, Lim YJ. The tenth rib line as a new landmark of the lumbar vertebral level during spinal block. Anaesthesia. 2004 Apr;59(4):359-63. doi: 10.1111/j.1365-2044.2004.03657.x.
PubMed 15023107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Arthropathy of Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Study of Landmarks for Spinal Anesthesia
ClinicalTrials.gov ID: NCT02330185
Acronym / sponsor ID: SALANDMARKUSG
Conditions: Arthropathy of Knee
Keywords: spinal anesthesia, ultrasonography, anatomical landmark
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Diskapi Yildirim Beyazit Education and Research HospitalOther government
Study start: Jan 2015
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 1 Jan 2015 (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.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
spinal anesthesia for knee arthroscopy	Experimental	Device: ultrasonographyThe intervention is spinal anesthesia. Tenth rib line or Tuffier's line will be examined as application landmarks by ultrasonography for spinal anesthesia.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

knee arthroscopic surgery

Key exclusion criteria (2 listed)

BMI>30
anatomical anomaly of vertebrae

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
ultrasonographyspinal anesthesia guided with ultrasonography	Device	spinal anesthesia for knee arthroscopy

Primary outcome

success of estimation the correct vertebral space
Time frame: 2 months
Independently, first anesthesist will determine the spinal anesthesia application point (intervertebral space) according to Tuffier's line and second anesthesist will determine it by ultrasonography. And third anesthesist will compare the accuracy of first determination.

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 5 Aug 2015.
Background: PubMed 15023107Jung CW, Bahk JH, Lee JH, Lim YJ. The tenth rib line as a new landmark of the lumbar vertebral level during spinal block. Anaesthesia. 2004 Apr;59(4):359-63. doi: 10.1111/j.1365-2044.2004.03657.x.

Related trials for Arthropathy of Knee

Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

dilek yazıcıoğlu study chair

anesthesiology and reanimation

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ultrasonography in people with Arthropathy of Knee, run by Diskapi Yildirim Beyazit Education and Research Hospital.

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 2 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 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

success of estimation the correct vertebral space (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02330185, 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 5 Aug 2015.