NCT03365271

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

November 25, 2017

Last Update Submit

December 2, 2017

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Swelling of the lower extremities

    one week after operation

  • Range of motion

    one week after operation

  • Pain

    one week after operation

Study Arms (2)

drainage

EXPERIMENTAL

A drainage will be applied in this group.

Procedure: drainage

without drainage

ACTIVE COMPARATOR

Non-drainage will be applied in this group.

Procedure: non-drainage

Interventions

drainagePROCEDURE

Applying a drain tube during TKA procedure

drainage
non-drainagePROCEDURE

No drain tube will be applied during TKA procedure

without drainage

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ready to receive single-side TKA
  • Be evaluated as ASA 1-2 degree before operation

You may not qualify if:

  • coagulation disorder
  • peripheral vessel diseases
  • contraindication of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Drainage

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Jianhao Lin, MD

    arthritis clinic and research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chutong Lin

CONTACT

+86 15652930253chutonglin@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The clinical professor of arthritis clinic and research center

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 7, 2017

Study Start

February 1, 2018

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

December 7, 2017

Record last verified: 2017-12