Clinical trial NCT02102581: Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty
Official title: Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Tourniquet
Total knee arthroplasty
Blood loss
Limb swelling
Limb circumference
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 consecutive patients who underwent routine TKA were included in this prospective randomized study.

Brief summary: To study the short-term effects of tourniquet use in different ways in total knee arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.Investigators want to observe the difference between the two groups. Hypothesis was made that patients in group B may feel better after operation for short time use of tourniquet.

Detailed description: Objective: To study the short-term effects of tourniquet use in different ways in total knee arthroplasty.

Methods: 60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for the study included those who underwent initial unilateral TKA for osteoarthritis or rheumatoid arthritis.

Exclusion Criteria:

* Patients with diabetes, hemorrhagic disease, Hb \< 100 g/L, peripheral neurovascular disease, malignant tumors, history of vascular thrombosis, or history of infection in the lower limb were excluded

Primary outcomes:
measure: the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14
timeFrame: 14 days after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: orthopedic department, Peking Union Medical College Hospital
Study officials:
affiliation: an orthopaedist of Peing Union Medical College Hospital
name: Yu Fan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fan Y, Jin J, Sun Z, Li W, Lin J, Weng X, Qiu G. The limited use of a tourniquet during total knee arthroplasty: a randomized controlled trial. Knee. 2014 Dec;21(6):1263-8. doi: 10.1016/j.knee.2014.08.002. Epub 2014 Sep 9.