NCT01470482

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

November 3, 2011

Last Update Submit

June 8, 2015

Conditions

Osteoarthritis, Knee

Keywords

Total kneeTourniquetBlood losspainrange of motion

Outcome Measures

Primary Outcomes (1)

  • View protocol record

    Measures the migration of the knee prosthesis

    2 years

Secondary Outcomes (1)

  • View Protocol Record

    2 years

Study Arms (2)

No Tourniquet

OTHER

We compare tourniquet or not in knee surgery

Procedure: No use of tourniquet

Tourniquet

ACTIVE COMPARATOR

We compare tourniquet or not in knee surgery

Procedure: Tourniquet

Interventions

No use of tourniquetPROCEDURE

Tourniquet is not applied i 25 pts

Also known as: No Tourniquet
No Tourniquet
TourniquetPROCEDURE

Use of tourniquet

Tourniquet

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motala hospital

Motala, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, KneeHemorrhagePain

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Per Aspenberg, MD,PhD

    Linkoeping University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 11, 2011

Study Start

August 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

SE(1)