Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet

March 17, 2015 updated by: Morten Grove Thomsen, Hvidovre University Hospital

Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: with tourniquet
Procedure: tourniquet
a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment
Placebo Comparator: without tourniquet
Procedure: no tourniquet
a tourniquet around the thigh is not used during insertion of the TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
migration of the prosthesis in millimeters assessed vith RSA.
Time Frame: 2 years
does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain.
Time Frame: 2 years
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
2 years
Patient satisfaction (VAS-scale)
Time Frame: 2 years
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
2 years
Knee range of motion (degrees)
Time Frame: 2 years
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Study Chair: Anders Troelsen, M.D, Ph.D, Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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