Does Tourniquet Use in Total Knee Replacement Improve Fixation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470482

Enrollment

Registered

2011-11-11

Start date

2006-08-31

Completion date

2010-05-31

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Total knee, Tourniquet, Blood loss, pain, range of motion

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

Interventions

PROCEDURENo use of tourniquet

Tourniquet is not applied i 25 pts

PROCEDURETourniquet

Use of tourniquet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
View protocol record	2 years	Measures the migration of the knee prosthesis

Secondary

Measure	Time frame	Description
View Protocol Record	2 years	Meassures of total bledding, ROM, KOOS, Pain

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026