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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01488175

Enrollment

Registered

2011-12-08

Start date

2012-01-31

Completion date

2015-01-31

Last updated

2015-03-18

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

Conditions

Osteoarthritis of the Knee

Keywords

TKA, RSA, Tourniquet, Arthroplasty, Knee

Brief summary

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.

Interventions

PROCEDUREtourniquet

a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment

PROCEDUREno tourniquet

a tourniquet around the thigh is not used during insertion of the TKA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

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