The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: non-drainage; Procedure: drainage

• Registration Number: NCT03365271
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.

Detailed Description

This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.

Study Timeline

• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-02
• Last Update Submitted: 2017-12-02
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-02
• Primary Completion: 2018-08
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Ready to receive single-side TKA
• Be evaluated as ASA 1-2 degree before operation

Exclusion Criteria

• coagulation disorder
• peripheral vessel diseases
• contraindication of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without drainage	non-drainage	Non-drainage will be applied in this group.
drainage	drainage	A drainage will be applied in this group.

Primary Outcome Measures

Name	Time	Method
The change of bleeding volume in perioperative period	before operation and one week after operation	The difference between baseline Hct collected before operation and Hct collected one week after operation

Secondary Outcome Measures

Name	Time	Method
Pain	one week after operation	Use the Visual Analogue Scale to estimate the pain and its score ranges from 0 to 10. The higher the score is, the more severe pain the patient is feeling.
Range of motion	one week after operation	Range of motion of the knee received operation
Swelling of the lower extremities	one week after operation	perimeter of lower extremities before and after operation