Clinical trial NCT02308410: Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty
Official title: Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty; a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Tourniquet
Postoperative outcome
Total knee arthroplasty
Lead sponsor: Medicort Sports & Orthopedic Care
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2014-12-04
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Score (KOOS) questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: Baseline, day 1, day 2, day 3 and 8 weeks
measure: Isometric bilateral strength
timeFrame: Baseline and 8 weeks
measure: VAS questionnaire.
timeFrame: Baseline, day 1, day 2, day 3 and 8 weeks
measure: EQ-5D questionnaire
timeFrame: Baseline, day 1, day 2, day 3 and 8 weeks
Other outcomes:
measure: Length of Stay (LOS)
timeFrame: Baseline, day 1, day 2 and day 3
measure: Used analgesics
timeFrame: Baseline, day 1, day 2 and day 3
Locations:
city: Naarden
country: Netherlands
facility: Bergman Clinic Naarden
state: Noord-Holland
city: Naarden
country: Netherlands
facility: Medicort Sports & Orthopedic Care
state: Noord-Holland
Study officials:
References:
citation: 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.