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

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Tourniquet application during surgery

• Registration Number: NCT02308410
• Lead Sponsor: Medicort Sports & Orthopedic Care

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-11-20
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-02
• Last Update Submitted: 2014-12-02
• Study First Posted: 2014-12-04
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tourniquet group	Tourniquet application during surgery	This group received a pneumatic tourniquet during total knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Score (KOOS) questionnaire	8 weeks	The KOOS questionnaire was used to assess the functional outcome. Changes were evaluated from baseline at 8 weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Medicort Sports & Orthopedic Care; 🇳🇱 Naarden, Noord-Holland, Netherlands

Bergman Clinic Naarden; 🇳🇱 Naarden, Noord-Holland, Netherlands