Osteoarthritis, Hip
Conditions
Keywords
Suction, Arthroplasty, Replacement, Hip
Brief summary
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.
Detailed description
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.
Interventions
DEVICEClosed Suction Drainage System
patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary Hip Arthroplasty * Lateral Hardinge Approach * Non-cemented Acetabular and Femoral Components * Length of Skin Incision between 10 and 20 cm
Exclusion criteria
* Coagulative Disorders * Previous Surgery in the same limb * Age below 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline red blood cells (RBC) | Pre-operative and 24 Hours Postoperative | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mid thigh circumference (cm) | Pre-operative and 24 Hours Postoperative to 3 Months Postoperative | Metric tape is placed midway between upper border of patella and superior anterior iliac spine |
| C-Reactive Protein (CRP) (mg/L) | 3,6 and 12 Weeks Postoperative | — |
| Erythrocyte sedimentation rate (ESR) (mm/h) | 3,6 and 12 Weeks Postoperative | — |
| Complications | during 3 months follow-up | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for Pain | Pre-operative and 24 Hours Postoperative | Scores range from 0 (no pain) to 10 (worst possible pain) |
| Harris Hip Score Questionnaire | Pre-operative and 3 Months Postoperative | \<70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent |
Countries
Brazil
Outcome results
None listed