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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Tourniquet application during surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tourniquet group<br>This group received a pneumatic tourniquet during total knee arthroplasty. | Procedure: Tourniquet application during surgery<br>* 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).<br>|
| Non-tourniquet group<br>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 | 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) | A standard clinical 30cm goniometer was used to evaluated the ROM | Baseline, day 1, day 2, day 3 and 8 weeks | 
| Isometric bilateral strength | Bilateral isometric strength of the lower limb was measured using hand-held dynamometry (HHD) | Baseline and 8 weeks | 
| VAS questionnaire. | 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 | Quality of life was using the EQ05D questionnaire. | Baseline, day 1, day 2, day 3 and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourniquet, Postoperative outcome, Total knee arthroplasty