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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308410
• Other study ID #: Medicort Bergman Tourniquet
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: December 2, 2014
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Medicort Sports & Orthopedic Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Bergman Clinic Naarden	Naarden	Noord-Holland
Netherlands	Medicort Sports & Orthopedic Care	Naarden	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Medicort Sports & Orthopedic Care	VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Stay (LOS)	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	No
Other	Used analgesics	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	No
Primary	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	No
Secondary	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	No
Secondary	Isometric bilateral strength	Bilateral isometric strength of the lower limb was measured using hand-held dynamometry (HHD)	Baseline and 8 weeks	No
Secondary	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	No
Secondary	EQ-5D questionnaire	Quality of life was using the EQ05D questionnaire.	Baseline, day 1, day 2, day 3 and 8 weeks	No