Total Knee ArthroplastyNCT04130009
Total Knee Arthroplasty With and Without Tourniquet: Comparative Study
A study testing Tourniquet use in people with Total Knee Arthroplasty, run by Hawler Medical University.
Trial summary
Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two… Read more about this study
- Who is it for?
- Ages 48 to 82 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Tourniquet use
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 20 Oct 2018
- 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 48 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment
Who cannot join
- Hb less than 12.
- D.M.,Blood dyscrasia.
- Any evidence of infection by screening test ESR and CRP. ,
- BMI more than 30.
About this study
Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B
Read the detailed description
This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters:
Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively.
Clinical DVT.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Tourniquet use
- Keywords
- Thigh pain, Total knee Arthroplasty, Tourniquet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet useProcedure or surgery
Also called No tourniquet use
Use of Tourniquet in The TKA
| Study group | Role | What they receive |
|---|---|---|
| TKA with tourniquet | Active comparator | This group was treated by TKA with the use of tourniquet Receives: Procedure: Tourniquet use |
| TKA without tourniquet | Active comparator | This group was treated by TKA without tourniquet Receives: Procedure: Tourniquet use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue score for thigh pain
This is measurement of the degree of thigh pain after operation which range from zero to 10
Measured: The VAS for thigh pain was measured in the day 14 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Mar 2016
- Primary completion10 Oct 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- This is comparative study between two groups one treated by Total knee with tourniquet and other group without tourniquet
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT04130009
- Sponsor's protocol ID
- HMU/Sherwan4
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty With and Without Tourniquet: Comparative Study
- ClinicalTrials.gov ID
- NCT04130009
- Acronym / sponsor ID
- HMU/Sherwan4
- Conditions
- Total Knee Arthroplasty
- Keywords
- Thigh pain, Total knee Arthroplasty, Tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 17 Oct 2019 (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.
Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B
Detailed description
This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters:
Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively.
Clinical DVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is comparative study between two groups one treated by Total knee with tourniquet and other group without tourniquet
| Arm | Type | Receives |
|---|---|---|
| TKA with tourniquet | Active comparator | Procedure: Tourniquet useThis group was treated by TKA with the use of tourniquet |
| TKA without tourniquet | Active comparator | Procedure: Tourniquet useThis group was treated by TKA without tourniquet |
Who may qualify
- Ages
- 48 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment
Key exclusion criteria (4 listed)
- Hb less than 12.
- D.M.,Blood dyscrasia.
- Any evidence of infection by screening test ESR and CRP. ,
- BMI more than 30.
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 useAlso: No tourniquet useUse of Tourniquet in The TKA | Procedure or surgery | TKA with tourniquet, TKA without tourniquet |
Primary outcome
Visual Analogue score for thigh pain
Time frame: The VAS for thigh pain was measured in the day 14 after operation
This is measurement of the degree of thigh pain after operation which range from zero to 10
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 17 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Total Knee Arthroplasty
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet use in people with 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 1 inclusion and 4 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 17 Oct 2019. 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?
Visual Analogue score for thigh pain (time frame: The VAS for thigh pain was measured in the day 14 after operation). 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 17 Oct 2019.