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

NCT ID: NCT01488175

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

with tourniquet

Group Type ACTIVE_COMPARATOR

tourniquet

Intervention Type PROCEDURE

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

without tourniquet

Group Type PLACEBO_COMPARATOR

no tourniquet

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tourniquet

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

Intervention Type PROCEDURE

no tourniquet

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Morten Grove Thomsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Troelsen, M.D, Ph.D

Role: STUDY_CHAIR

Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

Hvidovre, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-2-2011-100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.