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

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: drainage; Procedure: non-drainage

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drainage; A drainage will be applied in this group.	Procedure: drainage; Applying a drain tube during TKA procedure
Active Comparator: without drainage; Non-drainage will be applied in this group.	Procedure: non-drainage; No drain tube will be applied during TKA procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling of the lower extremities	perimeter of lower extremities before and after operation	one week after operation
Range of motion	Range of motion of the knee received operation	one week after operation
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Jianhao Lin, MD, arthritis clinic and research center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PUPHEMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No