Back to resultsThe Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
drainage
non-drainage
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
drainage
without drainage
Arm Description
A drainage will be applied in this group.
Non-drainage will be applied in this group.
Outcomes
Primary Outcome Measures
The change of bleeding volume in perioperative period
The difference between baseline Hct collected before operation and Hct collected one week after operation
Secondary Outcome Measures
Swelling of the lower extremities
perimeter of lower extremities before and after operation
Range of motion
Range of motion of the knee received 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.
Full Information
NCT ID
NCT03365271
First Posted
November 25, 2017
Last Updated
December 2, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03365271
Brief Title
The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
Official Title
Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2018 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drainage
Arm Type
Experimental
Arm Description
A drainage will be applied in this group.
Arm Title
without drainage
Arm Type
Active Comparator
Arm Description
Non-drainage will be applied in this group.
Intervention Type
Procedure
Intervention Name(s)
drainage
Intervention Description
Applying a drain tube during TKA procedure
Intervention Type
Procedure
Intervention Name(s)
non-drainage
Intervention Description
No drain tube will be applied during TKA procedure
Primary Outcome Measure Information:
Title
The change of bleeding volume in perioperative period
Description
The difference between baseline Hct collected before operation and Hct collected one week after operation
Time Frame
before operation and one week after operation
Secondary Outcome Measure Information:
Title
Swelling of the lower extremities
Description
perimeter of lower extremities before and after operation
Time Frame
one week after operation
Title
Range of motion
Description
Range of motion of the knee received operation
Time Frame
one week after operation
Title
Pain
Description
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.
Time Frame
one week after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chutong Lin
Phone
+86 15652930253
Email
chutonglin@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhao Lin, MD
Organizational Affiliation
arthritis clinic and research center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
We'll reach out to this number within 24 hrs