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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03365271
Enrollment
100
Registered
2017-12-07
Start date
2018-02-28
Completion date
2019-02-28
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

PROCEDUREdrainage

Applying a drain tube during TKA procedure

PROCEDUREnon-drainage

No drain tube will be applied during TKA procedure

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The change of bleeding volume in perioperative periodbefore operation and one week after operationThe difference between baseline Hct collected before operation and Hct collected one week after operation

Secondary

MeasureTime frameDescription
Swelling of the lower extremitiesone week after operationperimeter of lower extremities before and after operation
Range of motionone week after operationRange of motion of the knee received operation
Painone week after operationUse 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.

Contacts

Primary ContactChutong Lin
chutonglin@126.com+86 15652930253

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026