OsteoarthritisNCT02907047
Tourniquet vs. no Tourniquet During Total Knee Arthroplasty
A study testing tourniquet inflated and tourniquet not inflated in people with Osteoarthritis, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- tourniquet inflated and tourniquet not inflated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
- Diagnosis of osteoarthritis
Who cannot join
- Revision surgery
- Bilateral knee surgery
- Age <18 or >80
- BMI >40
- Baseline lower extremity strength less than 5/5
- Vascular calcifications
Show all 16Show fewer
- History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
- Functionally limiting spine disease
- Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
- Patients who cannot perform the baseline functional tests
- Allergy/contraindication to protocol medications
- Post-traumatic arthritis
- Inflammatory arthritis
- Pregnancy
- Prisoners
- Patients receiving care as part of a worker's compensable injury
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.
- Conditions
- Osteoarthritis
- Being tested
- tourniquet inflated, tourniquet not inflated
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquet inflatedOther
tourniquet not inflatedOther
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Active comparator | These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure Receives: Other: tourniquet inflated |
| No tourniquet | Other | These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure Receives: Other: tourniquet not inflated |
What is being measured
The primary outcome is the main question the study is designed to answer.
timed up and go (TUG) score
Measured: 4 weeks following surgery
Stair Climb test
time, in seconds, to climb one flight of nine stairs
Measured: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Visual Analog Scale: Pain
Measured: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Secondary outcomes (3)
blood loss
calculated blood loss determine by hemoglobin dilution
Measured: intra-operative
surgical field visualization
subjective rating provided by the surgeon
Measured: intra-operative
range of motion
measured, in degrees, using a goniometer
Measured: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Apr 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907047
- Sponsor's protocol ID
- 16Austin01
- Status last verified
- Jun 2019
- First submitted
- 15 Sep 2016
- Last updated
- 1 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquet vs. no Tourniquet During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02907047
- Acronym / sponsor ID
- 16Austin01
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 20 Sep 2016 (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 correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.
Study design
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Active comparator | Other: tourniquet inflatedThese subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure |
| No tourniquet | Other | Other: tourniquet not inflatedThese subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All unilateral primary knee arthroplasties performed by investigators participating in this study will be eligible for inclusion
- Diagnosis of osteoarthritis
Key exclusion criteria (16 listed)
- Revision surgery
- Bilateral knee surgery
- Age <18 or >80
- BMI >40
- Baseline lower extremity strength less than 5/5
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 |
|---|---|---|
| tourniquet inflated | Other | Tourniquet |
| tourniquet not inflated | Other | No tourniquet |
Primary outcome
timed up and go (TUG) score
Time frame: 4 weeks following surgery
Stair Climb test
Time frame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
time, in seconds, to climb one flight of nine stairs
Visual Analog Scale: Pain
Time frame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
3 secondary outcomes
blood loss
Time frame: intra-operative
surgical field visualization
Time frame: intra-operative
range of motion
Time frame: in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op
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 1 Jul 2019.
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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 tourniquet inflated and tourniquet not inflated in people with Osteoarthritis, run by Rothman Institute Orthopaedics 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 2 inclusion and 16 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 1 Jul 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 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?
timed up and go (TUG) score (time frame: 4 weeks following surgery). The study lists 3 primary outcomes in all. 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 1 Jul 2019.