Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedApril 3, 2014
March 1, 2014
10 months
March 24, 2014
March 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14
14 days after the surgery
Study Arms (1)
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).
Interventions
short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.
Eligibility Criteria
60 consecutive patients who underwent routine TKA were included in this prospective randomized study.
You may qualify if:
- Patients eligible for the study included those who underwent initial unilateral TKA for osteoarthritis or rheumatoid arthritis.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
orthopedic department, Peking Union Medical College Hospital
Beijing, 100730, China
Related Publications (1)
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.
PMID: 25212990DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Fan, MD
an orthopaedist of Peing Union Medical College Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 14 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
April 3, 2014
Study Start
February 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
April 3, 2014
Record last verified: 2014-03