OsteoarthritisNCT01808859
Tourniquet and Quadricepsforce
A study testing Tourniquet in people with Osteoarthritis and Total Knee Arthroplasty, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose for this study is to investigate the quadriceps (thigh) function preoperatively and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint) in a randomised study with or without the use of a Tourniquet (cuff around the thigh during surgery) (100 mm Hg > systolic blood… Read more about this study
- Who is it for?
- Ages 41 to 80 years
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Jul 2014
- 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 41 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 40 < 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.
- The patient understand the clinical investigation and will cooperate with the investigational team
Who cannot join
- Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppresed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI<35 Diabethic neuropathy Preopratively opiod or garbabentine treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept Orthopedic surgery, Hässleholm Hospital
Hässleholm, Skåne County, 281 25
About this study
Official title: The Effect of Tourniquet Use During Total Knee Arthroplasty Surgery on the Postoperative Loss of Quadricepsforce
The purpose for this study is to investigate the quadriceps (thigh) function preoperatively and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint) in a randomised study with or without the use of a Tourniquet (cuff around the thigh during surgery) (100 mm Hg > systolic blood pressure).
Read the detailed description
Introduction It is established that knee arthroplasty generate a loss of 60-80 % quadriceps-force during the first 2-3 days postoperatively [1-4]. This can reduce the postoperative rehabilitation and walking function. There is, due to this fact, an increased interest in analysing the mechanism behind this quadriceps weakness [5].
One of the mechanism behind this could be the routinely used - but not evidence based - application of an intra operative tourniquet. Several studies, including reviews and meta-analysis show that the use of blood less field is debatable and can be one reason for localised muscle necrosis and increased pain. The use of a tourniquet and the effect on the total perioperative blood loss is doubtful [6-11].
The use of a tourniquet or not has no effect on the prosthetic fixation to the bone (Molt/STL) The influence on the late (>2 weeks) quadriceps function and rehabilitation is even debatable.
[6-11], but there is no investigation on the effect of the use of a tourniquet on the early significant loss of quadriceps-function.
The purpose for this study is to investigate the quadriceps function preoperatively and 48 hours postoperatively during knee arthroplasty in a randomised study with or without the use of a Tourniquet (100 mm Hg > systolic blood pressure).
Methods
Design:
This is a randomised controlled blinded clinical study (unless for the surgeon) in two arms - 1) TKA operated on with the use of a Tourniquet, and 2) without the use of Tourniquet during surgery.
All effect measures are compiled preoperatively and at 48 hours postoperatively. Even at the 2 weeks and 2 month follow up the effect measures will be compiled?
Inclusion Inclusion criteria patients > 40 < 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.
The patient understand the clinical investigation and will cooperate with the investigational team
Exclusion criteria Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppressed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI<35?? Diabetic neuropathy Preoperatively opioid or garbabentin treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty
Should we do bilaterally Biodex/quadriceps investigation, i.e a "controlled" leg????
The surgical procedure All patients will be operated on using the Triathlon knee system without a patella component. The Tourniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed. The patients operated on in the non-tourniquet group will have the same surgery and surgical technique.
The incision will be equal for all patients, a straight skin incision and a paramedial quadriceps incision with eversion of the patella.
The blood loss will be compiled The preoperative Hb and Hb at 48 hours will be compiled
Perioperatively all patients will receive 150 m LIA [12]. The patients will be mobilised during the first 2 hours postoperatively.
Parameters
Primary parameter:
isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions.
The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight [1]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended [13] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.
Pain at rest and pain during the isometric test will be measured by a VAS scale [1].
The bloodloss will be measured and the Hb will be compiled before and after surgery. The number of transfusions will be registered.
Length of stay will be compiled. The time from surgery to the first mobilisation will be measured
Number of patients 64 patients will be included in this study by allocation to +/- Tourniquet (100 mm Hg > systolic blood pressure), 32 patients in each group. The power calculation is based on earlier data on the loss of knee extension force after a total knee arthroplasty [1]. With a loss of 40% muscle force (0.3 Nm/kg) without Tourniquet and a type I error of 5 % (p < 0,05) and a type II error of 20% (80% power) it is calculated that 58 patients should included be. To compensate for dropouts 64 patients will be included in this study.
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Tourniquet
- Keywords
- Total Knee Arthroplasty, Thigh Tourniquet
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetDevice
hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Experimental | The Torniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed Receives: Device: Tourniquet |
| No tourniquet | No intervention | The patients operated on in the non-tourniquet group will have the same surgery and surgical technique but without tourniquet hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
isometric quadriceps-force measured
isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions.
The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight [1]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended [13] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.
Measured: pre operatively and 48 hrs post op
Secondary outcomes (1)
Pain
Pain at rest and pain during the isometric test will be measured by a VAS scale
Measured: pre opertively and 48 hrs post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Harsten, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808859
- Sponsor's protocol ID
- Biodex2013
- Status last verified
- Nov 2014
- First submitted
- 28 Feb 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
PubMed 21044725Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14.
PubMed 18448878Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
PubMed 15866968Smith TO, Hing CB. Is a tourniquet beneficial in total knee replacement surgery? A meta-analysis and systematic review. Knee. 2010 Mar;17(2):141-7. doi: 10.1016/j.knee.2009.06.007. Epub 2009 Jul 19.
PubMed 19616954Ledin H, Aspenberg P, Good L. Tourniquet use in total knee replacement does not improve fixation, but appears to reduce final range of motion. Acta Orthop. 2012 Oct;83(5):499-503. doi: 10.3109/17453674.2012.727078. Epub 2012 Sep 14.
PubMed 22974220Harsten A, Bandholm T, Kehlet H, Toksvig-Larsen S. Tourniquet versus no tourniquet on knee-extension strength early after fast-track total knee arthroplasty; a randomized controlled trial. Knee. 2015 Mar;22(2):126-30. doi: 10.1016/j.knee.2014.12.010. Epub 2014 Dec 31.
PubMed 25648580
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tourniquet Use During Total Knee Arthroplasty Surgery on the Postoperative Loss of Quadricepsforce
- ClinicalTrials.gov ID
- NCT01808859
- Acronym / sponsor ID
- Biodex2013
- Conditions
- Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Thigh Tourniquet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Mar 2013 (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 for this study is to investigate the quadriceps (thigh) function preoperatively and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint) in a randomised study with or without the use of a Tourniquet (cuff around the thigh during surgery) (100 mm Hg > systolic blood pressure).
Detailed description
Introduction It is established that knee arthroplasty generate a loss of 60-80 % quadriceps-force during the first 2-3 days postoperatively [1-4]. This can reduce the postoperative rehabilitation and walking function. There is, due to this fact, an increased interest in analysing the mechanism behind this quadriceps weakness [5].
One of the mechanism behind this could be the routinely used - but not evidence based - application of an intra operative tourniquet. Several studies, including reviews and meta-analysis show that the use of blood less field is debatable and can be one reason for localised muscle necrosis and increased pain. The use of a tourniquet and the effect on the total perioperative blood loss is doubtful [6-11].
The use of a tourniquet or not has no effect on the prosthetic fixation to the bone (Molt/STL) The influence on the late (>2 weeks) quadriceps function and rehabilitation is even debatable.
[6-11], but there is no investigation on the effect of the use of a tourniquet on the early significant loss of quadriceps-function.
The purpose for this study is to investigate the quadriceps function preoperatively and 48 hours postoperatively during knee arthroplasty in a randomised study with or without the use of a Tourniquet (100 mm Hg > systolic blood pressure).
Methods
Design:
This is a randomised controlled blinded clinical study (unless for the surgeon) in two arms - 1) TKA operated on with the use of a Tourniquet, and 2) without the use of Tourniquet during surgery.
All effect measures are compiled preoperatively and at 48 hours postoperatively. Even at the 2 weeks and 2 month follow up the effect measures will be compiled?
Inclusion Inclusion criteria patients > 40 < 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.
The patient understand the clinical investigation and will cooperate with the investigational team
Exclusion criteria Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppressed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI<35?? Diabetic neuropathy Preoperatively opioid or garbabentin treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty
Should we do bilaterally Biodex/quadriceps investigation, i.e a "controlled" leg????
The surgical procedure All patients will be operated on using the Triathlon knee system without a patella component. The Tourniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed. The patients operated on in the non-tourniquet group will have the same surgery and surgical technique.
The incision will be equal for all patients, a straight skin incision and a paramedial quadriceps incision with eversion of the patella.
The blood loss will be compiled The preoperative Hb and Hb at 48 hours will be compiled
Perioperatively all patients will receive 150 m LIA [12]. The patients will be mobilised during the first 2 hours postoperatively.
Parameters
Primary parameter:
isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions.
The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight [1]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended [13] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.
Pain at rest and pain during the isometric test will be measured by a VAS scale [1].
The bloodloss will be measured and the Hb will be compiled before and after surgery. The number of transfusions will be registered.
Length of stay will be compiled. The time from surgery to the first mobilisation will be measured
Number of patients 64 patients will be included in this study by allocation to +/- Tourniquet (100 mm Hg > systolic blood pressure), 32 patients in each group. The power calculation is based on earlier data on the loss of knee extension force after a total knee arthroplasty [1]. With a loss of 40% muscle force (0.3 Nm/kg) without Tourniquet and a type I error of 5 % (p < 0,05) and a type II error of 20% (80% power) it is calculated that 58 patients should included be. To compensate for dropouts 64 patients will be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Experimental | Device: TourniquetThe Torniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed |
| No tourniquet | No intervention | –The patients operated on in the non-tourniquet group will have the same surgery and surgical technique but without tourniquet hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks. |
Who may qualify
- Ages
- 41 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients > 40 < 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.
- The patient understand the clinical investigation and will cooperate with the investigational team
Key exclusion criteria (1 listed)
- Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppresed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI<35 Diabethic neuropathy Preopratively opiod or garbabentine treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty
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 |
|---|---|---|
| Tourniquethyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks. | Device | Tourniquet |
Primary outcome
isometric quadriceps-force measured
Time frame: pre operatively and 48 hrs post op
isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions. The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight [1]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended [13] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.
1 secondary outcome
Pain
Time frame: pre opertively and 48 hrs 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 6 Nov 2014.
- Background: PubMed 21044725Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
- Background: PubMed 18448878Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14.
- Background: PubMed 15866968Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
- Background: PubMed 19616954Smith TO, Hing CB. Is a tourniquet beneficial in total knee replacement surgery? A meta-analysis and systematic review. Knee. 2010 Mar;17(2):141-7. doi: 10.1016/j.knee.2009.06.007. Epub 2009 Jul 19.
- Background: PubMed 22974220Ledin H, Aspenberg P, Good L. Tourniquet use in total knee replacement does not improve fixation, but appears to reduce final range of motion. Acta Orthop. 2012 Oct;83(5):499-503. doi: 10.3109/17453674.2012.727078. Epub 2012 Sep 14.
- Derived from this study: PubMed 25648580Harsten A, Bandholm T, Kehlet H, Toksvig-Larsen S. Tourniquet versus no tourniquet on knee-extension strength early after fast-track total knee arthroplasty; a randomized controlled trial. Knee. 2015 Mar;22(2):126-30. doi: 10.1016/j.knee.2014.12.010. Epub 2014 Dec 31.
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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 in people with Osteoarthritis and Total Knee Arthroplasty, run by Region Skane at 1 site in Sweden.
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 6 Nov 2014. 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 Sweden. 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?
isometric quadriceps-force measured (time frame: pre operatively and 48 hrs post op). 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 NCT01808859, which also lists 6 linked publications.
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 6 Nov 2014.