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

NCT ID: NCT03365271

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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drainage

A drainage will be applied in this group.

Group Type EXPERIMENTAL

drainage

Intervention Type PROCEDURE

Applying a drain tube during TKA procedure

without drainage

Non-drainage will be applied in this group.

Group Type ACTIVE_COMPARATOR

non-drainage

Intervention Type PROCEDURE

No drain tube will be applied during TKA procedure

Interventions

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drainage

Applying a drain tube during TKA procedure

Intervention Type PROCEDURE

non-drainage

No drain tube will be applied during TKA procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lin Chutong

The clinical professor of arthritis clinic and research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianhao Lin, MD

Role: PRINCIPAL_INVESTIGATOR

arthritis clinic and research center

Central Contacts

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Chutong Lin

Role: CONTACT

Phone: +86 15652930253

Email: [email protected]

Other Identifiers

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PUPHEMS

Identifier Type: -

Identifier Source: org_study_id