Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty

March 30, 2014 updated by: Peking Union Medical College Hospital

Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty: a Randomized Controlled Trial

To study the short-term effects of tourniquet use in different ways in total knee arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.Investigators want to observe the difference between the two groups. Hypothesis was made that patients in group B may feel better after operation for short time use of tourniquet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To study the short-term effects of tourniquet use in different ways in total knee arthroplasty.

Methods: 60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • orthopedic department, Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

60 consecutive patients who underwent routine TKA were included in this prospective randomized study.

Description

Inclusion Criteria:

  • Patients eligible for the study included those who underwent initial unilateral TKA for osteoarthritis or rheumatoid arthritis.

Exclusion Criteria:

  • Patients with diabetes, hemorrhagic disease, Hb < 100 g/L, peripheral neurovascular disease, malignant tumors, history of vascular thrombosis, or history of infection in the lower limb were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
short time tourniquet
60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation(short time).
Procedure: short time tourniquet
short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14
Time Frame: 14 days after the surgery
14 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Yu Fan, MD, an orthopaedist of Peing Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 30, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Estimate)

April 3, 2014

Last Update Submitted That Met QC Criteria

March 30, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orthopedic deparment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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