Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02102581

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Procedure: short time 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty: a Randomized Controlled Trial

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
short time tourniquet 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(short time).	Procedure: short time tourniquet short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.

Arm

Intervention/Treatment

short time tourniquet

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(short time).

Procedure: short time tourniquet

short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.

Outcome Measures

Primary Outcome Measures

the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14 [14 days after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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