Prospective cohort study to analyse the effect of negative suction drain in Total Knee Arthroplasty
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Pt B D Sharma PGIMS Rohtak
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To assess the effects of surgical drains on postoperative wound complications such as hematoma, infection, and delayed wound healing.
Study Overview
Brief Summary
Total knee arthroplasty (TKA) is a commonly performed procedure for advanced knee osteoarthritis. Postoperative closed suction drains are traditionally used to reduce hematoma formation, swelling, and wound complications. However, recent evidence suggests that drain usage may increase blood loss, transfusion requirements, and delay functional recovery without providing significant clinical benefit.
This prospective randomized controlled trial aims to compare the clinical and functional outcomes of patients undergoing primary total knee arthroplasty with and without postoperative closed suction drainage. A total of 24 patients will be randomly allocated into two groups: Group A (drain group) and Group B (no-drain group). Primary outcomes include postoperative hemoglobin drop and total blood loss. Secondary outcomes include wound complications, postoperative pain, functional outcome assessed using WOMAC score at 1 month, transfusion requirement, and duration of hospital stay.
The findings of this study will help determine whether routine use of postoperative suction drains provides any clinical or functional advantage in patients undergoing primary total knee arthroplasty.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing primary tka with posterior stablised or cruciate sacrificing prosthesis.
Exclusion Criteria
- •Patients with coagulopathy, inflammatory arthritis, simulataneous bilateral tkr, malignancy, revision tkr and patients on long term anticoagulant therapy.
Outcomes
Primary Outcomes
To assess the effects of surgical drains on postoperative wound complications such as hematoma, infection, and delayed wound healing.
Time Frame: immediate and 1 month
Secondary Outcomes
- 1. To evaluate the effect of drain usage on postoperative pain and knee swelling.(2. To compare the total blood loss and need for blood transfusions between patients)
Investigators
Dr Pradeep Kamboj
Department of Orthopaedics, PGIMS Rohtak