Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty

December 2, 2014 updated by: Medicort Sports & Orthopedic Care

Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study

A pneumatic tourniquet is often used during total knee arthroplasty. However, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. The purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (TKA) in the Bergman Clinic, the Netherlands were investigated. Patients scheduled for primary TKA due to osteoarthritis, age between 50 and 75 years and with Dutch language proficiency were eligible for inclusion. Exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, Body Mass Index (BMI) >35, severe coagulation disorders or hospitalization in the previous two months before surgery. Each patient included in the study signed informed consent. The research protocol was approved by the Regional Ethics Committee VCMO in Nieuwegein, the Netherlands, registration number W13.022.

Study Type

Observational

Enrollment (Actual)

99

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

  • Netherlands
    • Noord-Holland
      • Naarden, Noord-Holland, Netherlands, 1411 GE
        • Bergman Clinic Naarden
      • Naarden, Noord-Holland, Netherlands, 1411 GE
        • Medicort Sports & Orthopedic Care

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty in the Bergman Clinic Naarden, the Netherlands were investigated.

Description

Inclusion Criteria:

  • Scheduled TKA due to osteoarthritis
  • Age between 50 and 75 years
  • Dutch language proficiency
  • Signed informed consent

Exclusion Criteria:

  • Inflammatory arthritis
  • Severe cardiac complaints
  • Severe pulmonary disorders
  • Body Mass Index >35
  • Severe coagulation disorders
  • Hospitalization in the previous two months before surgery

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
Tourniquet group
This group received a pneumatic tourniquet during total knee arthroplasty.
Procedure: Tourniquet application during surgery
Both groups received usual care according to the orthopedic surgeons surgical preferences. One group received no tourniquet during surgery (non-tourniquet group) and the other group received a pneumatic tourniquet during surgery (tourniquet-group).
Non-tourniquet group
This group received no tourniquet during total knee arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Time Frame: 8 weeks
The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion (ROM)
Time Frame: Baseline, day 1, day 2, day 3 and 8 weeks
A standard clinical 30cm goniometer was used to evaluated the ROM
Baseline, day 1, day 2, day 3 and 8 weeks
Isometric bilateral strength
Time Frame: Baseline and 8 weeks
Bilateral isometric strength of the lower limb was measured using hand-held dynamometry (HHD)
Baseline and 8 weeks
VAS questionnaire.
Time Frame: Baseline, day 1, day 2, day 3 and 8 weeks
A 100mm Visual Analogue Scale was used for measuring current, minimal and maximal pain.
Baseline, day 1, day 2, day 3 and 8 weeks
EQ-5D questionnaire
Time Frame: Baseline, day 1, day 2, day 3 and 8 weeks
Quality of life was using the EQ05D questionnaire.
Baseline, day 1, day 2, day 3 and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay (LOS)
Time Frame: Baseline, day 1, day 2 and day 3
The total length of each the patients in hospital stay was calculated and evaluated for comparison between both groups.
Baseline, day 1, day 2 and day 3
Used analgesics
Time Frame: Baseline, day 1, day 2 and day 3
During the clinical phase, analgesic use was noted whereas the doses and time interval of each medication was recorded.
Baseline, day 1, day 2 and day 3

Collaborators and Investigators

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

Sponsor

Medicort Sports & Orthopedic Care

Collaborators

VU University of Amsterdam

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

October 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medicort Bergman Tourniquet

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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