NCT01488175

Brief Summary

The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 2, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

December 2, 2011

Last Update Submit

March 17, 2015

Conditions

Osteoarthritis of the Knee

Keywords

TKARSATourniquetArthroplastyKnee

Outcome Measures

Primary Outcomes (1)

  • migration of the prosthesis in millimeters assessed vith RSA.

    does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?

    2 years

Secondary Outcomes (3)

  • postoperative pain.

    2 years

  • Patient satisfaction (VAS-scale)

    2 years

  • Knee range of motion (degrees)

    2 years

Study Arms (2)

with tourniquet

ACTIVE COMPARATOR
Procedure: tourniquet

without tourniquet

PLACEBO COMPARATOR
Procedure: no tourniquet

Interventions

tourniquetPROCEDURE

a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment

with tourniquet
no tourniquetPROCEDURE

a tourniquet around the thigh is not used during insertion of the TKA

without tourniquet

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis og osteoarthritis of the knee
  • patients must be 18 years or older
  • patients must understand and speak danish
  • must be able to give signed consent

You may not qualify if:

  • severe medical illness
  • documented osteoporosis
  • rheumatoid arthritis
  • prior surgery in the knee
  • neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Anders Troelsen, M.D, Ph.D

    Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 8, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

DK(1)