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

Knee Osteoarthritis Clinical Trial

Official title:

Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365271
• Other study ID #: PUPHEMS
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 2, 2017
• Start date: February 2018
• Est. completion date: February 2019

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Chutong Lin
• Phone: +86 15652930253
• Email: chutonglin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• drainage
Applying a drain tube during TKA procedure
• non-drainage
No drain tube will be applied during TKA procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of bleeding volume in perioperative period	The difference between baseline Hct collected before operation and Hct collected one week after operation	before operation and one week after operation
Secondary	Swelling of the lower extremities	perimeter of lower extremities before and after operation	one week after operation
Secondary	Range of motion	Range of motion of the knee received operation	one week after operation
Secondary	Pain	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.	one week after operation