NCT01993758

Brief Summary

This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration 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, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

November 19, 2013

Last Update Submit

May 20, 2014

Conditions

Osteoarthritis

Keywords

tourniquet pressuretotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Acquisition of bloodless surgical field just after skin incision

    Dichotomous variable determined during operation by operator (Yes or No)

    just after skin incision during operation

Secondary Outcomes (7)

  • Failure of acquiring bloodless surgical field during operation

    after skin incision through the point of tourniquet deflation

  • Increasement of tourniquet pressure to acquire bloodless surgical field

    after skin incision though the point of tourniquet deflation

  • Thigh pain on the site of tourniquet application

    postoperative 2nd day

  • Knee pain

    postoperative 2nd day

  • Skin problem on the site of tourniquet application

    posteoperative 2nd day

  • +2 more secondary outcomes

Study Arms (2)

Conventional tourniquet pressure

ACTIVE COMPARATOR

The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.

Procedure: Conventional tourniquet pressure

Low tourniquet pressure

EXPERIMENTAL

The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.

Procedure: Low tourniquet pressure

Interventions

Low tourniquet pressurePROCEDURE

Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation

Low tourniquet pressure
Conventional tourniquet pressurePROCEDURE

Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation

Conventional tourniquet pressure

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients undergoing total knee arthroplasty

You may not qualify if:

  • Systolic blood pressure measured at ward \> 200mmHg
  • Thigh circumference \> 78cm
  • Anesthesia other than spinal anesthesia
  • Simultaneous bilateral total knee arthroplasty
  • The patients who disagreed the enrollment of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

  • Kim TK, Bamne AB, Sim JA, Park JH, Na YG. Is lower tourniquet pressure during total knee arthroplasty effective? A prospective randomized controlled trial. BMC Musculoskelet Disord. 2019 Jun 4;20(1):275. doi: 10.1186/s12891-019-2636-7.

    PMID: 31159799DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • T K Kim, MD, PhD

    Joint Reconstruction Center, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

T K Kim, MD, PhD

CONTACT

82-31-787-7196osktk@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

KR(1)