Use of Tourniquet in Total Knee ArthroplastyNCT04469166
Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up
A study testing tourniquet and No tourniquet in people with Use of Tourniquet in Total Knee Arthroplasty, run by Hawler Medical University.
Trial summary
This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Use of Tourniquet in Total Knee Arthroplasty
- What is being tested?
- tourniquet and No tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 30 Mar 2020
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Grade 3 and 4 osteoarthritis
- age 55-80 years
- patients agree to participate in the study
Who cannot join
- Smoking
- Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis.
- Hip pathology like osteoarthritis or fractures
- Neuromuscular disorders
- Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.
- Previous knee surgery or knee infection
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- Peripheral vascular disease
- Rheumatoid arthritis
- Hemoglobin less than 12 gram/deciliter
About this study
Official title: Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial
This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.
Read the detailed description
In this study, investigators have primary outcome measures and secondary outcome measures which were assessed in multiple periods to see the effects of using tourniquet in total knee arthroplasty on the clinical and functional outcomes with follow up of 5 years.
- Being tested
- tourniquet, No tourniquet
- Keywords
- Tourniquet, Total knee arthroplasty, Clinical outcomes, Functional outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquetProcedure or surgery
Use of tourniquet
No tourniquetProcedure or surgery
No use of tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Active comparator | Group of tourniquet Receives: Procedure: tourniquet |
| No tourniquet | Active comparator | Group of no tourniquet Receives: Procedure: No tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee society score
Knee society score for functional outcome which will be low in poor function and high in best function
Measured: This score was assessed at 5 years postoperatively
Knee injury and osteoarthritis outcome scores
Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function
Measured: This score was assessed at 5 years post-operatively
VAS for thigh pain
Visual analogue scale for thigh pain which will be high in more pain and low in less pain
Measured: This score was assessed at 1st day post-operatively
Secondary outcomes (1)
Post operative complications
The complications can occurred after surgery
Measured: These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Mar 2014
- Primary completion20 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Tourniquet in Total Knee ArthroplastyStudies 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
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469166
- Sponsor's protocol ID
- HMU/Sherwan 10
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon the publication of our study, I will decide to share my patients data
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04469166
- Acronym / sponsor ID
- HMU/Sherwan 10
- Keywords
- Tourniquet, Total knee arthroplasty, Clinical outcomes, Functional outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- 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.
This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.
Detailed description
In this study, investigators have primary outcome measures and secondary outcome measures which were assessed in multiple periods to see the effects of using tourniquet in total knee arthroplasty on the clinical and functional outcomes with follow up of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Active comparator | Procedure: tourniquetGroup of tourniquet |
| No tourniquet | Active comparator | Procedure: No tourniquetGroup of no tourniquet |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Grade 3 and 4 osteoarthritis
- age 55-80 years
- patients agree to participate in the study
Key exclusion criteria (9 listed)
- Smoking
- Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis.
- Hip pathology like osteoarthritis or fractures
- Neuromuscular disorders
- Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.
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 |
|---|---|---|
| tourniquetUse of tourniquet | Procedure or surgery | Tourniquet |
| No tourniquetNo use of tourniquet | Procedure or surgery | No tourniquet |
Primary outcome
Knee society score
Time frame: This score was assessed at 5 years postoperatively
Knee society score for functional outcome which will be low in poor function and high in best function
Knee injury and osteoarthritis outcome scores
Time frame: This score was assessed at 5 years post-operatively
Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function
VAS for thigh pain
Time frame: This score was assessed at 1st day post-operatively
Visual analogue scale for thigh pain which will be high in more pain and low in less pain
1 secondary outcome
Post operative complications
Time frame: These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.
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 2020.
- Individual participant dataSharing planned: Undecided. Upon the publication of our study, I will decide to share my patients data
Related trials for Use of Tourniquet in Total Knee Arthroplasty
Not yet recruiting
Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies
Knee Osteoarthritis (OA), Total Knee Anthroplasty
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.
Questions about this trial
What is this clinical trial studying?
A study testing tourniquet and No tourniquet in people with Use of Tourniquet in Total Knee Arthroplasty, run by Hawler Medical University.
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 9 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 2020. 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.
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?
Knee society score (time frame: This score was assessed at 5 years postoperatively). 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 13 Jul 2020.