NCT02986061

Brief Summary

The aim of this study was to investigate whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

November 30, 2016

Last Update Submit

December 7, 2016

Conditions

Urinary Catheter

Outcome Measures

Primary Outcomes (3)

  • Postoperative urinary retention

    7 days

  • Postoperative urinary tract infection

    7 days

  • Urine volume

    3 days

Secondary Outcomes (3)

  • Length of stay

    14 days

  • Intraoperative intravenous fluid

    1 day

  • Duration of the surgery

    1 day

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients with indwelling urinary catheter

Device: Urinary catheter

Study Group

NO INTERVENTION

Patients without indwelling urinary catheter

Interventions

Urinary catheterDEVICE
Control Group

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period.

You may not qualify if:

  • Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Joint Surgery, Southwest Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Urinary Catheters

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Central Study Contacts

Wei-Nan Zeng, MD

CONTACT

weinanzeng@163.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
Director

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 8, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2017

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)