NCT01470482

CompletedPhase 3

Does Tourniquet Use in Total Knee Replacement Improve Fixati...

Per Aspenberg Source

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Other study identifiers

Sponsor study identifier

Ledin01

Secondary identifiers

VR - 2009-6725).

OTHER · EPN Linköping M59-06

Study Type

interventional

Actual enrollment (reported)

50

Locations

1 country

Sites

1

Timeline

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 50 participants
Study completion date: May 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)
Study Completion
May 2010
Actual (reported)
First Submitted
November 3, 2011
Actual (reported)
First Posted
November 11, 2011
Actual (reported)

Last Updated: June 9, 2015
Status Verified: June 2015
Last Update Submitted: 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:

Sponsors & Collaborators

Per Aspenberg
Otherlead

Study Sites (1)

Motala hospital

Motala, Sweden

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)

Study Officials

Per Aspenberg, MD,PhD
Linkoeping University
STUDY DIRECTOR

Enrollment

50 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT00265447

Exercise and Physical Fitness for Persons With Knee Osteoarthritis

Phase 3Completed

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Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

Phase 3Completed

NCT00450112

Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

Phase 3Completed

NCT00503828

Derris Scandens Benth Extract VS Naproxen in Knee OA

Phase 3Completed

NCT00264225

Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)

Phase 3Completed

NCT01017445

Stick Versus Quadricep Exercise for Knee Osteoarthritis

Phase 3Unknown

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Equipment and Supplies

Primary Completion

May 2010

Actual (reported)

Study Completion

May 2010

Actual (reported)

Last Updated

June 9, 2015

Record last verified: 2015-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01470482
Data provider: ClinicalTrials.gov
Source updated: 2015-06-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:14 UTC

Locations

SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

No Tourniquet

Tourniquet

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations