Deep Vein ThrombosisNCT01559532
Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty
An observational study of Deep Vein Thrombosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is an observational study to analyze the influence of surgery duration and tourniquet time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Sep 2011
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Seventy-eight consecutive patients from our institution underwent cemented TKA for degenerative knee disorders and then underwent AV, for which they gave informed consent, at a point between 7 and 12 days after surgery, after having been discharged from the hospital.
Who may be able to join
- patients that underwent cemented total knee arthroplasty
Who cannot join
- post-operative infection
- inadequate follow-up
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Orthopedics Department - University of Sao Paulo General Hospital
São Paulo, São Paulo, 05403-010
About this study
This is an observational study to analyze the influence of surgery duration and tourniquet time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total knee arthroplasty (TKA).
Read the detailed description
Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty
Tourniquet, Surgery Duration and DVT in TKA.
Abstract:
Objective: The occurrence of deep vein thrombosis (DVT) was evaluated in 78 patients submitted to total knee arthroplasty (TKA), followed by ascending venography (AV), between the seventh and twelfth days postoperative.
Methods: Patients received prophylaxis with oral anticoagulation for 12 days, maintaining INR at around 2.5.
Results: Results showed 45 cases (57.7%) of negative bilateral AV and 33 (42.3%) cases of positivity for DVT. Thirteen cases were of the proximal type DVT, making up 16.7% of the total. We compared the groups with and without DVT, and another which considered only cases with proximal DVT.
Conclusion: The statistical analysis didn't reveal significance in relation to tourniquet time, despite the higher likelihood of proximal DVT after 90 minutes (p=0.08) and surgery duration of more than 120 minutes increases its risk.
Keywords: Deep vein thrombosis. Prophylaxis. Thromboembolism. Tourniquet. Knee prosthesis.
Introduction Total knee arthroplasties (TKAs), together with total hip arthroplasties, are frequently the object of study regarding deep vein thrombosis (DVT) (1); however, DVT also commonly occurs in other knee procedures (2). Despite the importance of this problem and the interest in it, most researchers studying DVT generally focus on prophylaxis for prevention; surprisingly, there have been few studies of the isolated risk factors for DVT associated with TKA. Although there is some controversy about the role of TKA alone as a risk factor for DVT (3-7), some researchers believe that bone manipulation, reaming of the medullary canal, and the duration of the different procedures are relevant risk factors for DVT (8,9). Another important and controversial factor related to TKA is the use of surgical tourniquets. Although all these factors are mentioned in the literature, surgery duration as an isolated risk factor for DVT in TKA has received little attention.
We used ascending venography (AV) to evaluate the association between the use of tourniquets and total procedure duration and the occurrence of DVT during TKA.
Patients and Methods Seventy-eight consecutive patients from our institution underwent cemented TKA for degenerative knee disorders and then underwent AV, for which they gave informed consent, at a point between 7 and 12 days after surgery, after having been discharged from the hospital. Of the 78, 78.2% were women and 21.8% were men, with an average age of 65.1 years (range, 31-88 years; SD, 11.5 years). Osteoarthrosis was the diagnosis in 74.4%, rheumatoid arthritis in 21.8%, and other disorders in 3.8%.
All patients received prophylaxis for DVT with oral anticoagulants for 12 days, with an international normalized ratio being maintained at about 2.5 (range, 2.0-3.0) in all cases. Perioperatively, we recorded total pneumatic tourniquet time and total surgery duration, in minutes. In all cases, the use of a tourniquet was interrupted by hemostasis, after cementation of the implant and before wound closure. Five categories were established for total tourniquet time: <60, 61 to 90, 91 to 120, and >120 minutes. The total procedure duration was defined in the same way; we recorded the times of the initial incision and the last suture stitch made to close the incision. Three categories were defined for procedure duration: <120, 121 to 150, and >150 minutes. Only 2 patients (3.1%) were given a general anesthetic; all the others were given a spinal block.
The study end point was defined as the execution of bilateral AV at a point between 7 and 12 days after surgery, after hospital discharge. The AV was carried out by a specialist in vascular radiology. The technique applied was basically that described by Rabinov and Paulin (10). The presence of clinically manifested DVT and/or pulmonary embolism was also taken in to consideration. The clinical manifestations of DVT were greater edema of the lower limb than would be expected for the procedure, associated with intense pain on palpation of the calf and pain on passive dorsiflexion of the foot.
AV findings were considered positive for DVT in the presence of blood clots in the vein lumens (Figure 1). They were characterized as occurring on the operated side, contralateral or bilateral, and were diagnosed as proximal DVT (more severe) or distal DVT (less severe), depending on the contents of the radiologist's report.
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Thromboembolism, Tourniquet, Knee prosthesis.
- Medical subject headings
- Venous Thrombosis, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ATK patients | Patients from our institution that underwent cemented TKA for degenerative knee disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep vein thrombosis
Deep vein thrombosis confirmed by ascending venography performed 7 days after total knee arthroplasty.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaldo J Hernandez, Prof. Dr., Study director, Orthopedics and Traumatology Department - University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559532
- Sponsor's protocol ID
- 222
- Status last verified
- Mar 2012
- First submitted
- 13 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergqvist D, Bergentz SE, Fredin H. Thromboembolism in orthopaedic surgery. Acta Orthop Scand. 1984 Jun;55(3):247-50. doi: 10.3109/17453678408992348. No abstract available.
PubMed 6204500Stringer MD, Steadman CA, Hedges AR, Thomas EM, Morley TR, Kakkar VV. Deep vein thrombosis after elective knee surgery. An incidence study in 312 patients. J Bone Joint Surg Br. 1989 May;71(3):492-7. doi: 10.1302/0301-620X.71B3.2785998.
PubMed 2785998Caprini JA, Arcelus JI, Reyna JJ. Effective risk stratification of surgical and nonsurgical patients for venous thromboembolic disease. Semin Hematol. 2001 Apr;38(2 Suppl 5):12-9. doi: 10.1016/s0037-1963(01)90094-0.
PubMed 11449339Geerts WH, Heit JA, Clagett GP, Pineo GF, Colwell CW, Anderson FA Jr, Wheeler HB. Prevention of venous thromboembolism. Chest. 2001 Jan;119(1 Suppl):132S-175S. doi: 10.1378/chest.119.1_suppl.132s. No abstract available.
PubMed 11157647Haas S. Prevention of venous thromboembolism: recommendations based on the International Consensus and the American College of Chest Physicians Sixth Consensus Conference on Antithrombotic Therapy. Clin Appl Thromb Hemost. 2001 Jul;7(3):171-7. doi: 10.1177/107602960100700301.
PubMed 11441977Stulberg BN, Insall JN, Williams GW, Ghelman B. Deep-vein thrombosis following total knee replacement. An analysis of six hundred and thirty-eight arthroplasties. J Bone Joint Surg Am. 1984 Feb;66(2):194-201.
PubMed 6693445Kim YH, Kim VE. Factors leading to low incidence of deep vein thrombosis after cementless and cemented total knee arthroplasty. Clin Orthop Relat Res. 1991 Dec;(273):119-24.
PubMed 1959258Haas S. Managing the risk of venous thromboembolism in orthopedics: concluding remarks. Orthopedics. 1997 Feb;20 Suppl:26-7. No abstract available.
PubMed 9048405Zaw HM, Osborne IC, Pettit PN, Cohen AT. Risk factors for venous thromboembolism in orthopedic surgery. Isr Med Assoc J. 2002 Nov;4(11):1040-2. No abstract available.
PubMed 12489502Rabinov K, Paulin S. Roentgen diagnosis of venous thrombosis in the leg. Arch Surg. 1972 Feb;104(2):134-44. doi: 10.1001/archsurg.1972.04180020014004. No abstract available.
PubMed 5008903Brookenthal KR, Freedman KB, Lotke PA, Fitzgerald RH, Lonner JH. A meta-analysis of thromboembolic prophylaxis in total knee arthroplasty. J Arthroplasty. 2001 Apr;16(3):293-300. doi: 10.1054/arth.2001.21499.
PubMed 11307125Freedman KB, Brookenthal KR, Fitzgerald RH Jr, Williams S, Lonner JH. A meta-analysis of thromboembolic prophylaxis following elective total hip arthroplasty. J Bone Joint Surg Am. 2000 Jul;82-A(7):929-38. doi: 10.2106/00004623-200007000-00004.
PubMed 10901307Lotke PA, Ecker ML, Alavi A, Berkowitz H. Indications for the treatment of deep venous thrombosis following total knee replacement. J Bone Joint Surg Am. 1984 Feb;66(2):202-8.
PubMed 6693446Wauke K, Nagashima M, Kato N, Ogawa R, Yoshino S. Comparative study between thromboembolism and total knee arthroplasty with or without tourniquet in rheumatoid arthritis patients. Arch Orthop Trauma Surg. 2002 Nov;122(8):442-6. doi: 10.1007/s00402-002-0404-9. Epub 2002 Apr 18.
PubMed 12442180Wakankar HM, Nicholl JE, Koka R, D'Arcy JC. The tourniquet in total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br. 1999 Jan;81(1):30-3. doi: 10.1302/0301-620x.81b1.8971.
PubMed 10067997
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01559532
- Acronym / sponsor ID
- 222
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Thromboembolism, Tourniquet, Knee prosthesis.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Mar 2012 (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.
This is an observational study to analyze the influence of surgery duration and tourniquet time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total knee arthroplasty (TKA).
Detailed description
Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty
Tourniquet, Surgery Duration and DVT in TKA.
Abstract:
Objective: The occurrence of deep vein thrombosis (DVT) was evaluated in 78 patients submitted to total knee arthroplasty (TKA), followed by ascending venography (AV), between the seventh and twelfth days postoperative.
Methods: Patients received prophylaxis with oral anticoagulation for 12 days, maintaining INR at around 2.5.
Results: Results showed 45 cases (57.7%) of negative bilateral AV and 33 (42.3%) cases of positivity for DVT. Thirteen cases were of the proximal type DVT, making up 16.7% of the total. We compared the groups with and without DVT, and another which considered only cases with proximal DVT.
Conclusion: The statistical analysis didn't reveal significance in relation to tourniquet time, despite the higher likelihood of proximal DVT after 90 minutes (p=0.08) and surgery duration of more than 120 minutes increases its risk.
Keywords: Deep vein thrombosis. Prophylaxis. Thromboembolism. Tourniquet. Knee prosthesis.
Introduction Total knee arthroplasties (TKAs), together with total hip arthroplasties, are frequently the object of study regarding deep vein thrombosis (DVT) (1); however, DVT also commonly occurs in other knee procedures (2). Despite the importance of this problem and the interest in it, most researchers studying DVT generally focus on prophylaxis for prevention; surprisingly, there have been few studies of the isolated risk factors for DVT associated with TKA. Although there is some controversy about the role of TKA alone as a risk factor for DVT (3-7), some researchers believe that bone manipulation, reaming of the medullary canal, and the duration of the different procedures are relevant risk factors for DVT (8,9). Another important and controversial factor related to TKA is the use of surgical tourniquets. Although all these factors are mentioned in the literature, surgery duration as an isolated risk factor for DVT in TKA has received little attention.
We used ascending venography (AV) to evaluate the association between the use of tourniquets and total procedure duration and the occurrence of DVT during TKA.
Patients and Methods Seventy-eight consecutive patients from our institution underwent cemented TKA for degenerative knee disorders and then underwent AV, for which they gave informed consent, at a point between 7 and 12 days after surgery, after having been discharged from the hospital. Of the 78, 78.2% were women and 21.8% were men, with an average age of 65.1 years (range, 31-88 years; SD, 11.5 years). Osteoarthrosis was the diagnosis in 74.4%, rheumatoid arthritis in 21.8%, and other disorders in 3.8%.
All patients received prophylaxis for DVT with oral anticoagulants for 12 days, with an international normalized ratio being maintained at about 2.5 (range, 2.0-3.0) in all cases. Perioperatively, we recorded total pneumatic tourniquet time and total surgery duration, in minutes. In all cases, the use of a tourniquet was interrupted by hemostasis, after cementation of the implant and before wound closure. Five categories were established for total tourniquet time: <60, 61 to 90, 91 to 120, and >120 minutes. The total procedure duration was defined in the same way; we recorded the times of the initial incision and the last suture stitch made to close the incision. Three categories were defined for procedure duration: <120, 121 to 150, and >150 minutes. Only 2 patients (3.1%) were given a general anesthetic; all the others were given a spinal block.
The study end point was defined as the execution of bilateral AV at a point between 7 and 12 days after surgery, after hospital discharge. The AV was carried out by a specialist in vascular radiology. The technique applied was basically that described by Rabinov and Paulin (10). The presence of clinically manifested DVT and/or pulmonary embolism was also taken in to consideration. The clinical manifestations of DVT were greater edema of the lower limb than would be expected for the procedure, associated with intense pain on palpation of the calf and pain on passive dorsiflexion of the foot.
AV findings were considered positive for DVT in the presence of blood clots in the vein lumens (Figure 1). They were characterized as occurring on the operated side, contralateral or bilateral, and were diagnosed as proximal DVT (more severe) or distal DVT (less severe), depending on the contents of the radiologist's report.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATK patients | – | –Patients from our institution that underwent cemented TKA for degenerative knee disorders. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy-eight consecutive patients from our institution underwent cemented TKA for degenerative knee disorders and then underwent AV, for which they gave informed consent, at a point between 7 and 12 days after surgery, after having been discharged from the hospital.
Key inclusion criteria (1 listed)
- patients that underwent cemented total knee arthroplasty
Key exclusion criteria (2 listed)
- post-operative infection
- inadequate follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Deep vein thrombosis
Time frame: 7 days
Deep vein thrombosis confirmed by ascending venography performed 7 days after total knee arthroplasty.
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 21 Mar 2012.
- Background: PubMed 6204500Bergqvist D, Bergentz SE, Fredin H. Thromboembolism in orthopaedic surgery. Acta Orthop Scand. 1984 Jun;55(3):247-50. doi: 10.3109/17453678408992348. No abstract available.
- Background: PubMed 2785998Stringer MD, Steadman CA, Hedges AR, Thomas EM, Morley TR, Kakkar VV. Deep vein thrombosis after elective knee surgery. An incidence study in 312 patients. J Bone Joint Surg Br. 1989 May;71(3):492-7. doi: 10.1302/0301-620X.71B3.2785998.
- Background: PubMed 11449339Caprini JA, Arcelus JI, Reyna JJ. Effective risk stratification of surgical and nonsurgical patients for venous thromboembolic disease. Semin Hematol. 2001 Apr;38(2 Suppl 5):12-9. doi: 10.1016/s0037-1963(01)90094-0.
- Background: PubMed 11157647Geerts WH, Heit JA, Clagett GP, Pineo GF, Colwell CW, Anderson FA Jr, Wheeler HB. Prevention of venous thromboembolism. Chest. 2001 Jan;119(1 Suppl):132S-175S. doi: 10.1378/chest.119.1_suppl.132s. No abstract available.
- Background: PubMed 11441977Haas S. Prevention of venous thromboembolism: recommendations based on the International Consensus and the American College of Chest Physicians Sixth Consensus Conference on Antithrombotic Therapy. Clin Appl Thromb Hemost. 2001 Jul;7(3):171-7. doi: 10.1177/107602960100700301.
- Background: PubMed 6693445Stulberg BN, Insall JN, Williams GW, Ghelman B. Deep-vein thrombosis following total knee replacement. An analysis of six hundred and thirty-eight arthroplasties. J Bone Joint Surg Am. 1984 Feb;66(2):194-201.
- Background: PubMed 1959258Kim YH, Kim VE. Factors leading to low incidence of deep vein thrombosis after cementless and cemented total knee arthroplasty. Clin Orthop Relat Res. 1991 Dec;(273):119-24.
- Background: PubMed 9048405Haas S. Managing the risk of venous thromboembolism in orthopedics: concluding remarks. Orthopedics. 1997 Feb;20 Suppl:26-7. No abstract available.
- Background: PubMed 12489502Zaw HM, Osborne IC, Pettit PN, Cohen AT. Risk factors for venous thromboembolism in orthopedic surgery. Isr Med Assoc J. 2002 Nov;4(11):1040-2. No abstract available.
- Background: PubMed 5008903Rabinov K, Paulin S. Roentgen diagnosis of venous thrombosis in the leg. Arch Surg. 1972 Feb;104(2):134-44. doi: 10.1001/archsurg.1972.04180020014004. No abstract available.
- Background: PubMed 11307125Brookenthal KR, Freedman KB, Lotke PA, Fitzgerald RH, Lonner JH. A meta-analysis of thromboembolic prophylaxis in total knee arthroplasty. J Arthroplasty. 2001 Apr;16(3):293-300. doi: 10.1054/arth.2001.21499.
- Background: PubMed 10901307Freedman KB, Brookenthal KR, Fitzgerald RH Jr, Williams S, Lonner JH. A meta-analysis of thromboembolic prophylaxis following elective total hip arthroplasty. J Bone Joint Surg Am. 2000 Jul;82-A(7):929-38. doi: 10.2106/00004623-200007000-00004.
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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.
Arnaldo J Hernandez, Prof. Dr. study director
Orthopedics and Traumatology Department - University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 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 21 Mar 2012. 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 Brazil. 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?
Deep vein thrombosis (time frame: 7 days). 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 NCT01559532, which also lists 15 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 21 Mar 2012.