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The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.
After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Suction Drainage System | Active Comparator | Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure |
|
| No Closed Suction Drainage System | No Intervention | Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed Suction Drainage System | Device | patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline red blood cells (RBC) | total RBC loss (mL) = [Uncompensated RBC loss (mL)] + [Compensated RBC loss (mL)] Uncompensated RBC loss (mL) = [Initial RBC (mL)] - [Final RBC (mL)] Compensated RBC loss (mL) = [Sum of RBCs received from the various sources of transfusion] Initial RBC (mL) = [Estimated blood volume (mL)] x [Initial Hct level (%)] at Day -1 Final RBC (mL) = [Estimated blood volume (mL)] x [Final Hct level (%)] at Day +3 Estimated blood volume (mL) = Women: [Body surface area (m2)] x 2430 Men: [Body surface area (m2)] x 2530 Body surface area (m2) = 0.0235 x [Height (cm)]0.42246 x [Weight (kg)]0.51456 Total blood loss at Hct level of 35% (mL) = [Total blood loss (mL)] / 0.35 | Pre-operative and 24 Hours Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Mid thigh circumference (cm) | Metric tape is placed midway between upper border of patella and superior anterior iliac spine | Pre-operative and 24 Hours Postoperative to 3 Months Postoperative |
| C-Reactive Protein (CRP) (mg/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for Pain | Scores range from 0 (no pain) to 10 (worst possible pain) | Pre-operative and 24 Hours Postoperative |
| Harris Hip Score Questionnaire | <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Ricardo Negreiros Vicente, MD PhD | Hip Surgery Group Instituto Ortopedia e Traumatologia do Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Ortopedia e Traumatologia do Hospital das ClÃnicas da Faculdade de Medicina da Universidade de São Paulo IOT-HCFMUSP | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23982636 | Background | Zhou XD, Li J, Xiong Y, Jiang LF, Li WJ, Wu LD. Do we really need closed-suction drainage in total hip arthroplasty? A meta-analysis. Int Orthop. 2013 Nov;37(11):2109-18. doi: 10.1007/s00264-013-2053-8. Epub 2013 Aug 28. | |
| 15022802 | Background | Gonzalez Della Valle A, Slullitel G, Vestri R, Comba F, Buttaro M, Piccaluga F. No need for routine closed suction drainage in elective arthroplasty of the hip: a prospective randomized trial in 104 operations. Acta Orthop Scand. 2004 Feb;75(1):30-3. doi: 10.1080/00016470410001708050. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 3,6 and 12 Weeks Postoperative |
| Erythrocyte sedimentation rate (ESR) (mm/h) | 3,6 and 12 Weeks Postoperative |
| Complications | during 3 months follow-up |
| Pre-operative and 3 Months Postoperative |
| 23917702 | Background | Chen ZY, Gao Y, Chen W, Li X, Zhang YZ. Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2014 Aug;24(6):939-46. doi: 10.1007/s00590-013-1284-0. Epub 2013 Aug 6. |
| 9113547 | Background | Ovadia D, Luger E, Bickels J, Menachem A, Dekel S. Efficacy of closed wound drainage after total joint arthroplasty. A prospective randomized study. J Arthroplasty. 1997 Apr;12(3):317-21. doi: 10.1016/s0883-5403(97)90029-2. |
| 19056215 | Background | Strahovnik A, Fokter SK, Kotnik M. Comparison of drainage techniques on prolonged serous drainage after total hip arthroplasty. J Arthroplasty. 2010 Feb;25(2):244-8. doi: 10.1016/j.arth.2008.08.014. Epub 2008 Dec 4. |
| 3403607 | Background | Willett KM, Simmons CD, Bentley G. The effect of suction drains after total hip replacement. J Bone Joint Surg Br. 1988 Aug;70(4):607-10. doi: 10.1302/0301-620X.70B4.3403607. |
| D012216 |
| Rheumatic Diseases |