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Does Tourniquet Use in Total Knee Replacement Improve Fixation

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
No use of tourniquet
Tourniquet
Sponsored by
Per Aspenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total knee, Tourniquet, Blood loss, pain, range of motion

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary or secondary osteoarthritis without other severe disease (ASA 1-2).

Exclusion Criteria:

  • were inability to give informed consent,
  • rheumatic arthritis,
  • malignancy,
  • coagulation disorder or medical treatment influencing the coagulation,
  • liver disease,
  • severe heart disease or bilateral operation.

Sites / Locations

  • Motala hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

No Tourniquet

Tourniquet

Arm Description

We compare tourniquet or not in knee surgery

We compare tourniquet or not in knee surgery

Outcomes

Primary Outcome Measures

View protocol record
Measures the migration of the knee prosthesis

Secondary Outcome Measures

View Protocol Record
Meassures of total bledding, ROM, KOOS, Pain

Full Information

First Posted
November 3, 2011
Last Updated
June 8, 2015
Sponsor
Per Aspenberg
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1. Study Identification

Unique Protocol Identification Number
NCT01470482
Brief Title
Does Tourniquet Use in Total Knee Replacement Improve Fixation
Official Title
Does Tourniquet Use in Total Knee Replacement Improve Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Aspenberg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.
Detailed Description
The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration. We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not. Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis. Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Total knee, Tourniquet, Blood loss, pain, range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Tourniquet
Arm Type
Other
Arm Description
We compare tourniquet or not in knee surgery
Arm Title
Tourniquet
Arm Type
Active Comparator
Arm Description
We compare tourniquet or not in knee surgery
Intervention Type
Procedure
Intervention Name(s)
No use of tourniquet
Other Intervention Name(s)
No Tourniquet
Intervention Description
Tourniquet is not applied i 25 pts
Intervention Type
Procedure
Intervention Name(s)
Tourniquet
Intervention Description
Use of tourniquet
Primary Outcome Measure Information:
Title
View protocol record
Description
Measures the migration of the knee prosthesis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
View Protocol Record
Description
Meassures of total bledding, ROM, KOOS, Pain
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary or secondary osteoarthritis without other severe disease (ASA 1-2). Exclusion Criteria: were inability to give informed consent, rheumatic arthritis, malignancy, coagulation disorder or medical treatment influencing the coagulation, liver disease, severe heart disease or bilateral operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Aspenberg, MD,PhD
Organizational Affiliation
Linkoeping University
Official's Role
Study Director
Facility Information:
Facility Name
Motala hospital
City
Motala
Country
Sweden

12. IPD Sharing Statement

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Does Tourniquet Use in Total Knee Replacement Improve Fixation

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