Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty

NCT01559532 | Completed

• 1 other identifier: 222
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Thromboembolism; Tourniquet; Knee prosthesis.

Outcome Measures

Primary Outcomes (1)

• Deep vein thrombosis

  Deep vein thrombosis confirmed by ascending venography performed 7 days after total knee arthroplasty.

  7 days

Study Arms (1)

ATK patients

Patients from our institution that underwent cemented TKA for degenerative knee disorders.

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• patients that underwent cemented total knee arthroplasty

You may not qualify if:

• post-operative infection
• inadequate follow-up

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Orthopedics Department - University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (15)

• 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.

  PMID: 6204500 BACKGROUND

• Stringer 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.

  PMID: 2785998 BACKGROUND

• Caprini 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.

  PMID: 11449339 BACKGROUND

• Geerts 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.

  PMID: 11157647 BACKGROUND

• Haas 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.

  PMID: 11441977 BACKGROUND

• Stulberg 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.

  PMID: 6693445 BACKGROUND

• Kim 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.

  PMID: 1959258 BACKGROUND

• Haas S. Managing the risk of venous thromboembolism in orthopedics: concluding remarks. Orthopedics. 1997 Feb;20 Suppl:26-7. No abstract available.

  PMID: 9048405 BACKGROUND

• Zaw 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.

  PMID: 12489502 BACKGROUND

• Rabinov 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.

  PMID: 5008903 BACKGROUND

• Brookenthal 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.

  PMID: 11307125 BACKGROUND

• Freedman 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.

  PMID: 10901307 BACKGROUND

• Lotke 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.

  PMID: 6693446 BACKGROUND

• Wauke 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.

  PMID: 12442180 BACKGROUND

• Wakankar 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.

  PMID: 10067997 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arnaldo J Hernandez, Prof. Dr.

  Orthopedics and Traumatology Department - University of Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

BR (1)