Arthropathy of KneeNCT04733716
Does Tourniquet Use Have an Effect on Pain and Function After Total Knee Arthroplasty
A study testing Using Tourniquet in people with Arthropathy of Knee and Pain, Joint, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) is an effective surgical procedure for reducing knee joint pain and improving the quality of life of patients with advanced knee osteoarthritis. Although advanced surgical techniques and prosthesis design are achieved, postoperative pain is a significant factor that affects those patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthropathy of Knee, Pain, Joint
- What is being tested?
- Using Tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2019to 1 Jan 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary knee osteoarthritis
- older than 18 years
- primary knee arthroplasty
Who cannot join
- Patients with a neurological disorder,
- diagnosed with fibromyalgia,
- history of knee operation,
- valgus knee,
- greater than 30° flexion contracture
- undergone bilateral knee arthroplasty or revision knee arthroplasty,
- chronic analgesic users, a
- patient with psychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Training and Research Hospital
Istanbul, Umraniye, 34760
About this study
Official title: Tourniquet Use Does Not Affect Pain and Function After Total Knee Arthroplasty: Patient Evaluation According to Pain Threshold
Total knee arthroplasty (TKA) is an effective surgical procedure for reducing knee joint pain and improving the quality of life of patients with advanced knee osteoarthritis. Although advanced surgical techniques and prosthesis design are achieved, postoperative pain is a significant factor that affects those patients who have undergone TKA with a satisfactory outcome. The reasons for postoperative pain after TKA are somewhat unclear Although there are studies evaluating the preoperative and postoperative conditions of the patients using pain scores, these values differ greatly in patients who are suitable for the same procedure. Previous studies have demonstrated that variability exists between individuals in basal pain sensitivity, which is assessed using quantitative sensory testing To our knowledge, only one study has investigated the pain condition using an algometer and postoperative pain and the analgesic requirement on the day of surgery and during the postoperative period.Unlike the above-cited study, in this study, we evaluated the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.
Read the detailed description
This is a prospective double-blinded, randomized controlled trial diagnostic study conducted at a single center from June 2018 to December 2019. Patients who underwent total knee arthroplasty due to end-stage knee osteoarthritis were asked to volunteer to participate in this study. A prospective randomized study was conducted using a digital algometer to assess the pain sensitivity for the relationship between postoperative early-stage pain score and first-year functional scores in patients with or without using tourniquet who underwent primary TKA. Patients were randomized to with or without tourniquet groups; a random number generated by the research staff determined the group designation, independent of a senior surgeon. T All participants in this study gave their written informed consent. Patients with a neurological disorder, diagnosed with fibromyalgia, history of knee operation, valgus knee, greater than 30° flexion contracture that had undergone bilateral knee arthroplasty or revision knee arthroplasty, chronic analgesic users, and those with a psychiatric disease were excluded from this study.
Preoperative Procedure: All patients had anterior-posterior and lateral radiographs of the bilateral knees, taken with a standard full-length weight-bearing the patients in bipedal stance, the knees in maximal extension for anterior-posterior and 30-degree flexion for lateral radiographs pre and postoperatively. In all patients, range of motion and contractures of both knee joints were recorded. All patient's educational level was also assessed. The pain threshold (PT) was evaluated using an analog algometer (Figure 1). The pain sensitivity was measured on the forearm using two mechanical pain stressors, which indicate which of an ascending sensory stimulus is first perceived as painful. This device is a force gauge that is used to apply an increasing amount of force to the skin through a 1 cm2 surface area until the pain threshold is achieved. This algometer stimulates pain, described as dull pressure at the pain threshold; the reliability and validity of this device have been reported. The pain sensitivity of all measurement patients was taken on the day before the surgery by the same author, and these values were blinded from another author who recorded the repetitive postoperative VAS and knee scores.
Operation Procedure: All patients were operated on in a single-center and experiences in arthroplasty practice. All the patients were operated on standard spinal anesthesia. All patients underwent cruciate-retaining Genesis II knee arthroplasty (Smith and Nephew, Memphis, TN, USA) with a midline incision and medial parapatellar approach with a fixed bearing design. Patella resurfacing was not performed, while patellar denervation was performed in all patients. Bone-cement (40 g) was used with a fourth-generation cementing device.
A pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the skin incision until skin closure in group 1 and no used in group 2. The tourniquet was inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure. Peri-operative tranexamic (TXA) acid was administrated intravenously with 20 mg/kg 30 min before surgery. Periarticular injection was not used for pain control in either group. An adductor canal block or epidural analgesia was not applied. Intra-articular drainage was used in every patient, which was removed after 24 h postoperatively.
Postoperative Management and Analgesic Procedure: On the day of surgery, intravenous paracetamol 1 g was given at 8-h intervals, and intramuscular diclofenac sodium 75 mg and intravenous tramadol 100 mg in 100 mL normal saline were given at 12-h intervals. This analgesic procedure was continued at the time of discharge, and all patients were discharged on the third day of surgery. Physical therapy was started on postoperative day 1 in all patients. The functional assessments and range-of-motion were measured during routine physical therapy sessions.
Postoperative Assessment of Pain and Function: VAS score assessment was done at 24 h (rest), 36 h (post-physical therapy), and 48 h (rest) postoperatively. The Knee Society Clinical Scoring System (KSS) was also used for evaluation of functional outcomes, which is a condition-specific validated questionnaire widely used to evaluate the functional capabilities of the knee joint before and after total knee arthroplasty. The KSS was done in the first year postoperatively. The KSS consists of two parts. One part is the knee score (KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the function score, which has two components, walking capacity and stair-climbing ability and deductions done if the patient using any assistive devices.
- Conditions
- Arthropathy of Knee, Pain, Joint
- Being tested
- Using Tourniquet
- Keywords
- Knee Arthroplasty
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using TourniquetProcedure or surgery
The purpose of this prospective randomized double blinded study was to compare the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty with using Tourniquet | Active comparator | A pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the skin incision until skin closure in this group. The tourniquet was inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure. Receives: Procedure: Using Tourniquet |
| Total Knee Arthroplasty without using Tourniquet | Active comparator | A pneumatic tourniquet was not used in this group during the total knee arthroplasty. Receives: Procedure: Using Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Outcome-1
Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.
Measured: 24 hour
Visual Analog Scale Outcome-2
Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.
Measured: 36 hour
Visual Analog Scale Outcome-3
Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.
Measured: 48 hour
Knee Society Score
The Knee society score (KSS) consists of two parts. One part is the knee score (KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the function score, which has two components, walking capacity and stair-climbing ability and deductions done if the patient using any assistive devices.
Measured: First year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Jun 2019
- Primary completion10 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Çamur, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733716
- Sponsor's protocol ID
- 2020/13
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquet Use Does Not Affect Pain and Function After Total Knee Arthroplasty: Patient Evaluation According to Pain Threshold
- ClinicalTrials.gov ID
- NCT04733716
- Acronym / sponsor ID
- 2020/13
- Conditions
- Arthropathy of Knee, Pain, Joint
- Keywords
- Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 2 Feb 2021 (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.
Total knee arthroplasty (TKA) is an effective surgical procedure for reducing knee joint pain and improving the quality of life of patients with advanced knee osteoarthritis. Although advanced surgical techniques and prosthesis design are achieved, postoperative pain is a significant factor that affects those patients who have undergone TKA with a satisfactory outcome. The reasons for postoperative pain after TKA are somewhat unclear Although there are studies evaluating the preoperative and postoperative conditions of the patients using pain scores, these values differ greatly in patients who are suitable for the same procedure. Previous studies have demonstrated that variability exists between individuals in basal pain sensitivity, which is assessed using quantitative sensory testing To our knowledge, only one study has investigated the pain condition using an algometer and postoperative pain and the analgesic requirement on the day of surgery and during the postoperative period.Unlike the above-cited study, in this study, we evaluated the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.
Detailed description
This is a prospective double-blinded, randomized controlled trial diagnostic study conducted at a single center from June 2018 to December 2019. Patients who underwent total knee arthroplasty due to end-stage knee osteoarthritis were asked to volunteer to participate in this study. A prospective randomized study was conducted using a digital algometer to assess the pain sensitivity for the relationship between postoperative early-stage pain score and first-year functional scores in patients with or without using tourniquet who underwent primary TKA. Patients were randomized to with or without tourniquet groups; a random number generated by the research staff determined the group designation, independent of a senior surgeon. T All participants in this study gave their written informed consent. Patients with a neurological disorder, diagnosed with fibromyalgia, history of knee operation, valgus knee, greater than 30° flexion contracture that had undergone bilateral knee arthroplasty or revision knee arthroplasty, chronic analgesic users, and those with a psychiatric disease were excluded from this study.
Preoperative Procedure: All patients had anterior-posterior and lateral radiographs of the bilateral knees, taken with a standard full-length weight-bearing the patients in bipedal stance, the knees in maximal extension for anterior-posterior and 30-degree flexion for lateral radiographs pre and postoperatively. In all patients, range of motion and contractures of both knee joints were recorded. All patient's educational level was also assessed. The pain threshold (PT) was evaluated using an analog algometer (Figure 1). The pain sensitivity was measured on the forearm using two mechanical pain stressors, which indicate which of an ascending sensory stimulus is first perceived as painful. This device is a force gauge that is used to apply an increasing amount of force to the skin through a 1 cm2 surface area until the pain threshold is achieved. This algometer stimulates pain, described as dull pressure at the pain threshold; the reliability and validity of this device have been reported. The pain sensitivity of all measurement patients was taken on the day before the surgery by the same author, and these values were blinded from another author who recorded the repetitive postoperative VAS and knee scores.
Operation Procedure: All patients were operated on in a single-center and experiences in arthroplasty practice. All the patients were operated on standard spinal anesthesia. All patients underwent cruciate-retaining Genesis II knee arthroplasty (Smith and Nephew, Memphis, TN, USA) with a midline incision and medial parapatellar approach with a fixed bearing design. Patella resurfacing was not performed, while patellar denervation was performed in all patients. Bone-cement (40 g) was used with a fourth-generation cementing device.
A pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the skin incision until skin closure in group 1 and no used in group 2. The tourniquet was inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure. Peri-operative tranexamic (TXA) acid was administrated intravenously with 20 mg/kg 30 min before surgery. Periarticular injection was not used for pain control in either group. An adductor canal block or epidural analgesia was not applied. Intra-articular drainage was used in every patient, which was removed after 24 h postoperatively.
Postoperative Management and Analgesic Procedure: On the day of surgery, intravenous paracetamol 1 g was given at 8-h intervals, and intramuscular diclofenac sodium 75 mg and intravenous tramadol 100 mg in 100 mL normal saline were given at 12-h intervals. This analgesic procedure was continued at the time of discharge, and all patients were discharged on the third day of surgery. Physical therapy was started on postoperative day 1 in all patients. The functional assessments and range-of-motion were measured during routine physical therapy sessions.
Postoperative Assessment of Pain and Function: VAS score assessment was done at 24 h (rest), 36 h (post-physical therapy), and 48 h (rest) postoperatively. The Knee Society Clinical Scoring System (KSS) was also used for evaluation of functional outcomes, which is a condition-specific validated questionnaire widely used to evaluate the functional capabilities of the knee joint before and after total knee arthroplasty. The KSS was done in the first year postoperatively. The KSS consists of two parts. One part is the knee score (KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the function score, which has two components, walking capacity and stair-climbing ability and deductions done if the patient using any assistive devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty with using Tourniquet | Active comparator | Procedure: Using TourniquetA pneumatic tourniquet was used before surgery at the proximal thigh and inflated before the skin incision until skin closure in this group. The tourniquet was inflated to either 275 or 325 mmHg, depending on the patient's systolic blood pressure. |
| Total Knee Arthroplasty without using Tourniquet | Active comparator | Procedure: Using TourniquetA pneumatic tourniquet was not used in this group during the total knee arthroplasty. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary knee osteoarthritis
- older than 18 years
- primary knee arthroplasty
Key exclusion criteria (8 listed)
- Patients with a neurological disorder,
- diagnosed with fibromyalgia,
- history of knee operation,
- valgus knee,
- greater than 30° flexion contracture
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 |
|---|---|---|
| Using TourniquetThe purpose of this prospective randomized double blinded study was to compare the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold. | Procedure or surgery | Total Knee Arthroplasty with using Tourniquet, Total Knee Arthroplasty without using Tourniquet |
Primary outcome
Visual Analog Scale Outcome-1
Time frame: 24 hour
Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.
Visual Analog Scale Outcome-2
Time frame: 36 hour
Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.
Visual Analog Scale Outcome-3
Time frame: 48 hour
Both groups were also evaluated with Visual Analog Scale for assess the pain status postoperatively.
Knee Society Score
Time frame: First year
The Knee society score (KSS) consists of two parts. One part is the knee score (KSS1), which includes pain (maximum 50 points), stability, total range of flexion, and other items (varus, valgus, extension delay, and flexion contracture). The other part (KSS2) is the function score, which has two components, walking capacity and stair-climbing ability and deductions done if the patient using any assistive devices.
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 2 Feb 2021.
- Individual participant dataSharing planned: No
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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 Using Tourniquet in people with Arthropathy of Knee and Pain, Joint, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 8 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 2 Feb 2021. 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 Turkey (Türkiye). 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?
Visual Analog Scale Outcome-1 (time frame: 24 hour). The study lists 4 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 2 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.