Knee ArthritisSkin to ACNCT03562559

Skin to Adductor Canal Distance in Various Positions

An observational study of Knee Arthritis, run by University of British Columbia at 1 site in Canada.

Completed

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

Trial summary

To control pain after total knee replacement surgery a catheter (tubing) is sometimes inserted into an anatomic space containing nerves that provide sensation to parts of the knee. This space is called the adductor canal. The catheters often stop working before we remove them for unclear reasons. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Knee Arthritis
What is being tested?: Measurements Using Ultrasound
How many people: 40 participants
Where: 1 siteCanada
Study dates: 1 Apr 2018to 1 Jan 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: We are recruiting patients undergoing total knee replacement. Per hospital protocol, patients will receive a spinal anesthetic and adductor canal block as part of their anesthetic regimen. After surgery, previously consented patients will have their skin to adductor canal distance measured by ultrasound in 5 different positions.

Who may be able to join

Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
Patients must be undergoing a primary total knee arthroplasty with neuraxial anaesthesia

Who cannot join

Patients with an allergy to ultrasound transducer gel or measuring tape

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

Official title: The Impact of Leg Movement on the Skin to Adductor Canal Distance: a Potential Cause for Catheter Displacement?

The catheters often stop working before we remove them for unclear reasons. The investigators think this is because the catheters become dislodged from where it was meant to be. This could be due to repeated movements of the catheter tip brought on by patients contracting their leg muscles when they ambulate or perform physio.

The investigators want to confirm this by measuring the distance from a fixed spot on the patient's thigh to the adductor canal using an ultrasound machine. The leg will be measured in various positions to simulate muscle movements. A significant change in the distance could possibly contribute to catheter dislodgement and result in catheter failure.

Conditions: Knee Arthritis
Being tested: Measurements Using Ultrasound
Keywords: Total Knee Arthroplasty, Adductor Canal Block

What participants receive

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

Measurements Using UltrasoundOther
Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.

Study groups in NCT03562559
Study group	Role	What they receive
TKA Patients		Not described Receives: Other: Measurements Using Ultrasound

What is being measured

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

Skin to Adductor Canal Distance Disparity
The largest distance disparity as measured from the 5 different leg positions
Measured: Measurements will be made on the day of surgery, no other assessment or follow up needed

Timeline

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

1 Apr 20181 Jan 2019

First posted19 Jun 2018
Study start1 Apr 2018
Primary completion1 Jan 2019
Study completion1 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee ArthritisStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe 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: Case only
Time perspective: Cross-sectional
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03562559
Sponsor's protocol ID: H17-02633
Acronym: Skin to AC
Status last verified: Sep 2019
First submitted: 29 May 2018
Last updated: 27 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tholin M, Wilson J, Lee S, Tang R, Sawka A, Vaghadia H. Impact of leg movement on skin-adductor canal distance: a potential cause for catheter tip displacement? Can J Anaesth. 2020 Aug;67(8):936-941. doi: 10.1007/s12630-020-01693-6. Epub 2020 May 8.
PubMed 32385824

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?

See locations

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All Knee Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Leg Movement on the Skin to Adductor Canal Distance: a Potential Cause for Catheter Displacement?
ClinicalTrials.gov ID: NCT03562559
Acronym / sponsor ID: Skin to AC / H17-02633
Conditions: Knee Arthritis
Keywords: Total Knee Arthroplasty, Adductor Canal Block
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 1 Jan 2019 (actual)
Study completion: 1 Jan 2019 (actual)
First posted: 19 Jun 2018 (actual)
Results: Posted 27 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
TKA Patients	–	Other: Measurements Using Ultrasound

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: We are recruiting patients undergoing total knee replacement. Per hospital protocol, patients will receive a spinal anesthetic and adductor canal block as part of their anesthetic regimen. After surgery, previously consented patients will have their skin to adductor canal distance measured by ultrasound in 5 different positions.

Key inclusion criteria (2 listed)

Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
Patients must be undergoing a primary total knee arthroplasty with neuraxial anaesthesia

Key exclusion criteria (1 listed)

Patients with an allergy to ultrasound transducer gel or measuring tape

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
Measurements Using UltrasoundUltrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.	Other	TKA Patients

Primary outcome

Skin to Adductor Canal Distance Disparity
Time frame: Measurements will be made on the day of surgery, no other assessment or follow up needed
The largest distance disparity as measured from the 5 different leg positions

Results and safety

Results posted to the registry on 27 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TKA Patients	40	40

Primary outcome: Skin to Adductor Canal Distance Disparity

Time frame: Measurements will be made on the day of surgery, no other assessment or follow up needed. Mean (90% Confidence Interval). Unit: centimeters

Measure	TKA Patients n = 40
Neutral vs manual displacement distance (cm)	1.01 (0.83 to 1.20)
Neutral vs external rotation distance (cm)	0.28 (0.16 to 0.39)
Neutral vs straight leg raise distance (cm)	0.43 (0.29 to 0.57)
Neutral vs leg flexion distance (cm)	0.63 (0.47 to 0.79)

Adverse events

Time frame: Adverse event date was not collected since this was an observational study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TKA Patients	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32385824Tholin M, Wilson J, Lee S, Tang R, Sawka A, Vaghadia H. Impact of leg movement on skin-adductor canal distance: a potential cause for catheter tip displacement? Can J Anaesth. 2020 Aug;67(8):936-941. doi: 10.1007/s12630-020-01693-6. Epub 2020 May 8.
Individual participant dataSharing planned: No

Related trials for Knee Arthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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.
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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.

Jason Wilson, MD principal investigator

University of British Columbia

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 Knee Arthritis, run by University of British Columbia at 1 site in Canada.

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 2 inclusion and 1 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 27 Sep 2019. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Skin to Adductor Canal Distance Disparity (time frame: Measurements will be made on the day of surgery, no other assessment or follow up needed). 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 NCT03562559, 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 27 Sep 2019.